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Tofacitinib

Phase 3

Ankylosing Spondylitis | Small molecule | Immunology |Pfizer, Inc.|Last Updated: Jun 16, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment478
FDA Designations
No designations recorded
Clinical trial landscape

Tofacitinib · 19 trials · 10 indications

Phase 3 9Phase 2 5Phase 1 5
NCT04624230Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative ColitisUlcerative Colitis
ACTIVE NOT_RECRUITING118 Analytics
NCT03486457Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic ArthritisPsoriatic Arthritis
COMPLETED204 Analytics
NCT03502616Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)Ankylosing Spondylitis
COMPLETED270 Analytics
NCT02281552A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED209 Analytics
NCT01976364Open-Label Extension Study Of Tofacitinib In Psoriatic ArthritisArthritis, Psoriatic
COMPLETED686 Analytics
NCT01877668Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator StudyPsoriatic Arthritis
COMPLETED422 Analytics
NCT01882439Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF InhibitorsPsoriatic Arthritis
COMPLETED395 Analytics
NCT01458951A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative ColitisUlcerative Colitis
COMPLETED547 Analytics
NCT01465763A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative ColitisUlcerative Colitis
COMPLETED614 Analytics
PHASE3ACTIVE NOT_RECRUITING
Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis
Ulcerative ColitisUnlock trial analytics
PHASE3COMPLETED
Efficacy And Safety Of Tofacitinib In Chinese Subjects With Active Psoriatic Arthritis
Psoriatic ArthritisUnlock trial analytics
PHASE3COMPLETED
Efficacy and Safety of Tofacitinib in Subjects With Active Ankylosing Spondylitis (AS)
Ankylosing SpondylitisUnlock trial analytics
PHASE3COMPLETED
A Study To Evaluate The Safety And Efficacy Of Tofacitinib Modified Release Tablets Compared To Tofacitinib Immediate Release Tablets In Adult Patients With Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics
PHASE3COMPLETED
Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis
Arthritis, PsoriaticUnlock trial analytics
PHASE3COMPLETED
Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study
Psoriatic ArthritisUnlock trial analytics
PHASE3COMPLETED
Tofacitinib In Psoriatic Arthritis Subjects With Inadequate Response to TNF Inhibitors
Psoriatic ArthritisUnlock trial analytics
PHASE3COMPLETED
A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis
Ulcerative ColitisUnlock trial analytics
PHASE3COMPLETED
A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis
Ulcerative ColitisUnlock trial analytics
Study Endpoints
Primary Endpoints
Remission by central read Mayo score following 44 weeks in the maintenance phase.
Outcome measured at the end of the 44 weeks of the maintenance phase.

Remission is defined by central endoscopy read Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. The primary outcome Mayo score is the summation of 4 subscores as listed below : * patient reported stool frequency (scored 0 to 3) * patient reported rectal bleeding (scored 0 to 3) * central read findings on endoscopy (scored 0 to 3) * physician's global assessment (scored 0 to 3) The Mayo score has a scale from 0 to 12 points, with the lower score indicating lower ulcerative colitis (UC) disease activity.

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 3
Month 3

ACR50 response: greater than or equal to (≥) 50% improvement in tender (TJC) and swollen joint counts (SJC) and ≥50% improvement in 3 of the 5 remaining ACR-core set measures: patient (PtGA) and physician global assessments (PhyGA), pain, disability (Health Assessment Questionnaire - Disability Index \[HAQ-DI\], scored from 0 to 3), and an acute-phase reactant (C-reactive protein \[CRP\]). TJC was based on 68 joints and SJC was based on 66 joints. PtGA, PhyGA and Pain were VAS on a scale of 0-100 millimeter (mm).

Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS)20 Response at Week 16
Week 16

ASAS20 assess 4 domains: Patient Global Assessment of Disease (PGA) (assess disease activity on a scale of 0 \[not active\] to 10 \[very active\], high score=more disease activity), total back pain (scale of 0 \[no pain\] to 10 \[most severe pain\], high score=more severity), Function (Bath Ankylosing Spondylitis Functional Index \[BASFI\]; participant's level of ability on scale of 0 \[easy\] to 10 \[impossible\], low score= better functional health) and Inflammation (morning stiffness, Mean of Question \[Q\]5 and Q6 of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] defined as 6-item questionnaire measure disease activity on a scale of 0 \[none\] to 10 \[severe\], high score=more disease activity). ASAS20 response: greater than or equal to (\>=) 20 percent (%) improvement from baseline in disease activity and absolute change of \>=1 unit in \>=3 domains and no worsening of \>=20% and an absolute change of \>=1 unit in remaining domain.

Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (C-Reactive Protein [CRP]) at Week 12
Baseline, Week 12

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, CRP (milligrams per liter \[mg/L\]) and patient global assessment of disease activity on a 100 millimeter (mm) visual analog scale (VAS: scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity. DAS28-4 (CRP) \[less than or equal to\] \<= 3.2 implied low disease activity and greater than (\>) 3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28-4 (CRP) less than (\<) 2.6 implied remission.

Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 48 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious AEs.

Number of Adverse Events (AEs) by Severity
Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)

An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs were classified into 3 categories according to their severity as mild AEs (did not interfere with participant's usual function), moderate AEs (interfered to some extent with participant's usual function) and severe AEs (interfered significantly with participant's usual function).

Number of Participants With Abnormal Clinical Laboratory Values
Date of first dose of study medication up to 48 months (36 months of main study and 12 months of sub-study)

Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes,neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin \[total, direct, indirect\], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids (cholesterol, HDL, LDL, triglyceride, apolipoprotein \[A-1, B\]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy (urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Laboratory abnormality: determined by investigator per pre-defined criteria.

Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Values
Date of first dose of study medication (Baseline) up to 48 months (36 months of main study and 12 months of sub-study)

Laboratory tests: hematology (Hb, hematocrit, RBC count, platelets, reticulocytes, WBC count, count and absolute lymphocytes, neutrophils, basophils, eosinophils, monocytes. Liver function (bilirubin\[total,direct,indirect\], AST, ALT, alkaline phosphatase, gamma-glutamyl transferase, albumin, total protein), renal function (blood urea nitrogen, creatinine), Lipids(cholesterol, HDL, LDL, triglyceride, apolipoprotein \[A-1, B\]), electrolytes (sodium, potassium, chloride, calcium, biocarbonate), chemistry (glucose, HbA1c, creatinine kinapse), urinalysis dipstick(urine-pH, glucose, ketones, protein, blood, leukocyte, esterase), urinalysis microscopy(urine- RBC, WBC, bacteria, epithelial cells),C-reactive protein. Clinically significant change: determined by investigator per pre-defined criteria.

Sub-study: Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score at Month 6
Sub-study: Baseline (Day 1), Month 6

HAQ-DI assessed the degree of difficulty a participant had experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, reach, grip, hygiene, and other activities. There were total of 2-3 items distributed in each of these 8 domains. Each item was scored for level of difficulty on a 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible HAQ-DI score ranged from 0 (least difficulty) to 3 (extreme difficulty), where higher score indicated more difficulty while performing daily living activities.

Sub-study: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) at Month 6
Sub-study: Baseline (Day 1), Month 6

PASDAS was composite PsA disease activity score that included following components: Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) in millimeter (mm), swollen (66 joints) and tender joint counts (68 joints), Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6), tender dactylitic digit score (scored on a scale of 0-3, where 0= no tenderness and 3= extreme tenderness), short form-36 questionnaire (SF-36) physical component summary (norm-based domain scores were used in analyses; with a population mean of 50 with a SD of 10 points, and ranges from minus infinity to plus infinity) and C-reactive protein (CRP) in milligram per liter (mg/L). PASDAS was composite score and was a weighted index with score range of 0 to 10, where higher score indicated more severe disease.

Percentage of Participants Meeting American College of Rheumatology Response Criteria ≥20% (ACR20): Month 3
At end of Month 3

ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire - disability index (HAQ-DI), and C-reactive protein (CRP).

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
From Baseline to Month 3

The HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability.

Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20): Month 3
Month 3

ACR20 was calculated as a ≥20% improvement from baseline in tender/painful and swollen joint counts and ≥20% improvement from baseline in 3 of the 5 remaining ACR core set measures: patient's global assessment of arthritis, physician's global assessment of arthritis, patient's assessment of arthritis pain, Health Assessment Questionnaire - Disability Index (HAQ-DI), and C-reactive protein (CRP).

Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score: Month 3
Month 3

The HAQ-DI assesses the difficulty a patient has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question, level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The score for each domain is the maximum (worst) score from the items/questions within the domain. Higher score indicates greater disability. Overall score was computed as the sum of the domain scores divided by the number of domains answered. The total possible score ranged from 0 to 3 where 0 = least difficulty and 3 = extreme difficulty. Higher overall score indicates greater disability.

Percentage of Participants With Remission at Week 8
Week 8

Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of Ulcerative Colitis . It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher score indicating more severe disease.

Fold Change From Baseline in Varicella Zoster Virus (VZV)-Specific Immunoglobulin G (IgG) Levels at Week 4
Baseline (pre-vaccination; Day -14), Week 4 (6 weeks post-vaccination)

VZV-specific IgG levels as measured by enzyme-linked immunosorbent assay (ELISA).

Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 12
Week 12

The primary analysis of this outcome measure was performed using the Emax model. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 \[least\] to 10 \[worst\]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.

Percentage of Participants Achieving ASAS20 at Week 12
Baseline, Week 12

The supportive analysis of this outcome measure was performed using the normal approximation for two proportions. Clinical response to treatment was assessed according to ASAS20 criteria. ASAS20 responder had improvement of ≥ 20% and ≥1 unit in at least 3 domains (on a scale of 0 \[least\] to 10 \[worst\]) and no worsening of ≥20% and ≤1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Missing data were handled by NRI/LOCF. Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.

Number of Participants With Laboratory Test Abnormalities
During study treatment (maximum up to 118 months)

Parameters: Hematology (hemoglobin, hematocrit, erythrocytes, platelets, leukocytes, lymphocytes, lymphocytes/leukocytes, neutrophils, neutrophils/leukocytes, basophils, basophils/leukocytes, eosinophils, eosinophils/leukocytes, monocytes, monocytes/leukocytes, prothrombin international normalized ratio, erythrocyte sedimentation rate), clinical chemistry (bilirubin, direct/indirect bilirubin, aspartate/alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, alkaline phosphatase, protein, albumin, blood urea nitrogen, creatinine, cholesterol, high and low density lipoprotein cholesterol, Friedewald estimation, triglycerides, sodium, potassium, chloride, calcium, bicarbonate, glucose, creatine kinase, C reactive protein), urinalysis (specific gravity, potential of hydrogen (pH), glucose/ protein/ hemoglobin/ erythrocytes/ leukocytes, ketones, leukocyte esterase, hyaline casts, bacteria). Number of participants with at least 1 laboratory abnormality are reported.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
From start of the study intervention up to 28 days after last dose of the study intervention or until study completion or withdrawal, whichever is longer (maximum up to 118 months from start of study intervention)

An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily had a causal relationship with the treatment or usage. A serious AE (SAE) was defined as any untoward medical occurrence at any dose that met one or more of the following criteria: resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. An TEAE was any AE that occurred following the start of study treatment in this study or increased in severity following the start of study treatment in this study. AE included both SAEs and all non-SAEs.

Absolute Values of Body Weight at Baseline
At Baseline

Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

Absolute Value of Body Weight at Month 12 and Its Change From Baseline at Month 12
Baseline, Month 12

Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

Absolute Value of Body Weight at Month 24 and Its Change From Baseline at Month 24
Baseline, Month 24

Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

Absolute Value of Body Weight at Month 36 and Its Change From Baseline at Month 36
Baseline, Month 36

Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

Absolute Value of Body Weight at Month 48 and Its Change From Baseline at Month 48
Baseline, Month 48

Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

Absolute Value of Body Weight at Month 60 and Its Change From Baseline at Month 60
Baseline, Month 60

Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

Absolute Value of Body Weight at Month 72 and Its Change From Baseline at Month 72
Baseline, Month 72

Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

Absolute Value of Body Weight at Month 84 and Its Change From Baseline at Month 84
Baseline, Month 84

Body weight was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

Absolute Value of Height at Baseline
At Baseline

Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

Absolute Value of Height at Month 12 and Its Change From Baseline at Month 12
Baseline, Month 12

Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

Absolute Value of Height at Month 24 and Its Change From Baseline at Month 24
Baseline, Month 24

Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

Absolute Value of Height at Month 36 and Its Change From Baseline at Month 36
Baseline, Month 36

Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

Absolute Value of Height at Month 48 and Its Change From Baseline at Month 48
Baseline, Month 48

Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

Absolute Value of Height at Month 60 and Its Change From Baseline at Month 60
Baseline, Month 60

Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

Absolute Value of Height at Month 72 and Its Change From Baseline at Month 72
Baseline, Month 72

Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

Absolute Value of Height at Month 84 and Its Change From Baseline at Month 84
Baseline, Month 84

Height was collected to assess growth and physical development. Baseline value was based on the enrollment gap: either from the qualifying studies (A3921103 \[NCT01513902\], A3921104 \[NCT02592434\], or A3921165 \[NCT03000439\]) (when participants enrolled in the current extension study within 14 days of the last visit of the qualifying/ index study), or from the current extension study (A3921145 \[NCT01500551\]) (when enrollment was out of 14-day window).

Number of Participants According to Tanner Stage at Baseline
At Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap)

Pubertal development was measured using Tanner stage, by age group (2 to \<6 years, 6 to \<12 years, and 12 years or older) for males and females separately. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (fully developed breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes continue to enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size).

Number of Participants With Shift in Tanner Stage From Baseline to Month 12
Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 12

Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 12. Only rows with non-zero values were reported in this outcome measure.

Number of Participants With Shift in Tanner Stage From Baseline to Month 24
Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 24

Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 24. Only rows with non-zero values were reported in this outcome measure.

Number of Participants With Shift in Tanner Stage From Baseline to Month 36
Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 36

Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 36. Only rows with non-zero values were reported in this outcome measure.

Number of Participants With Shift in Tanner Stage From Baseline to Month 48
Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 48

Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 48. Only rows with non-zero values were reported in this outcome measure.

Number of Participants With Shift in Tanner Stage From Baseline to Month 60
Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 60

Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 60. Only rows with non-zero values were reported in this outcome measure.

Number of Participants With Shift in Tanner Stage From Baseline to Month 72
Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 72

Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 72. Only rows with non-zero values were reported in this outcome measure.

Number of Participants With Shift in Tanner Stage From Baseline to Month 84
Baseline (from the qualifying/ index studies or the current extension study based on the enrollment gap), at Month 84

Pubertal development was measured using Tanner stage, by age group and gender. Assessment included, 1) Male: pubic hair and size of genitalia and 2) Female: pubic hair and breast exam. There were 5 stages for each assessment type. Stages for, a) Pubic hair: 1 (no hair), 2 (downy hair), 3 (scant terminal hair), 4 (terminal hair filled entire triangle overlying pubic region), 5 (terminal hair extended beyond inguinal crease onto thigh); b) Breast exam: 1 (no breast development), 2 (breasts buds), 3 (breast tissue palpable outside areola; no areolar development), 4 (secondary mounds, separation of contours), 5 (full breast); c) Genitalia: 1 (no genital growth), 2 (enlargement of scrotum and testes), 3 (penis grow in size, testes enlarge), 4 (penis grow in length/ breadth, scrotum darkens, testes enlarge), 5 (adult shape and size). Number of participants are reported per shift in Tanner stage from Baseline to Month 84. Only rows with non-zero values were reported in this outcome measure.

Percentage of Participants Achieving a 75% Reduction in the Psoriasis Area and Severity Index (PASI75) at Week 12
Week 12

Combined assessment of lesion severity and area affected into single score; range equals (=) 0 (no disease) to 72 (maximal disease). Body divided into 4 sections=head, upper/lower limbs, trunk; each area scored by itself and scores combined for final PASI. For each section percent area of skin involved was estimated: 0 (0%) to 6 (90-100%) and severity estimated by clinical signs of erythema, induration, scaling; ranged 0-4: 0=none, 1=slight, 2=moderate, 3=marked, 4=very marked. Final PASI=sum of severity parameters for each section\*area score\*weighing factor (head=0.1, upper limbs=0.2, trunk=0.3, lower limbs=0.4) summed over all sections.

Percentage of Participants Achieving a Physician's Global Assessment (PGA) Response of "Clear" or "Almost Clear" at Week 12
Week 12

PGA psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration and scaling across all psoriatic lesions. PGA of Psoriasis scale ranges from 0 (no psoriasis) to 4 (severe disease). ‘Clear’ and “Almost clear’ includes all participants who were scored as a 0 or 1.

Percentage of Participants With Clinical Response
Week 8

Clinical response was defined as a decrease from baseline in Mayo score of at least 3 points and at least 30 percent, with accompanying decrease in subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1. Mayo score: instrument designed to measure disease activity of ulcerative colitis. Total score range: 0 to 12; higher score=more severe disease. It consisted of 4 subscores: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy and physician global assessment, each ranged from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe).

AUCinf for tofacitinib oral solution and tofacitinib tablet
24 hrs after study drug administration in Period 1 and Period 2

Area under the curve from time zero to extrapolated infinite time for both oral solution and tofacitinib.

AUClast for tofacitinib oral solution and tofacitinib tablet
24 hrs after study drug administration in Period 1 and Period 2

Area under the plasma concentration time curve from 0 to time of the last measurement of both the tofacitinib oral solution and tofacitinib tablet.

Area under the plasma concentration time profile from time zero extrapolated to infinite time (AUCinf)
Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment.
Area under the plasma concentration time profile from time zero to the time of the last quantifiable concentration (AUClast)
Plasma PK samples will be collected pre dose and after the Day 1 AM dose of MR and IR treatments and the PM dose of the IR treatment.
Area under the concentration time profile for the 24 hour period (AUC24)
Blood samples for assessing steady state PK will be collected prior to dosing on Days 5, 6 and 7 and after dosing on Day 7 (up to 24 hours post Day 7 AM dose)
AUC inf
48 hours post dose

Area under the plasma concentration-time profile from time zero to infinity (AUCinf).

AUC last
48 hours post dose

Area under the plasma concentration-time profile from time zero to time of last identifiable quantitation (AUC last).

Cmax
48 hours post dose

Maximum observed plasma concentration (Cmax).

Area under the plasma concentration-time profile from time zero extrapolated to infinite time (AUCinf )
24 hours
Maximum plasma concentration (Cmax)
24 hours
Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 1
23 hours (hrs) prior to morning dose on Day 1 (Baseline for HPD 1), 1 hour (hr) post morning dose on Day 1

Triplicate 12-lead electrocardiogram (ECG) measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled hour post morning dose (HPD), except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 1
22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 1

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled hour post morning dose (HPD), except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 1
20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 1

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 1
16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 1

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 1
12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 1

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Change From Baseline in QT Interval at 16 Hour Post Morning Dose (HPD 16) on Day 1
8 hrs prior to morning dose on Day 1 (Baseline for HPD 16), 16 hrs post morning dose on Day 1

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.Change from baseline in QT interval at HPD 16 was planned to be analyzed for participants who received CP-690,550 60 mg and matching placebo.

Change From Baseline in QT Interval at 0 Hour Post Morning Dose (HPD 0) on Day 14
Hour 0 (pre-dose) on Day 1 (Baseline for HPD 0), 0 hr on Day 14

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles. The mean of the triplicates at HPD=0 on Day 1 will be defined as the baseline for HPD=0.

Change From Baseline in QT Interval at 1 Hour Post Morning Dose (HPD 1) on Day 14
23 hrs prior to morning dose on Day 1 (Baseline for HPD 1), 1 hr post morning dose on Day 14

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Change From Baseline in QT Interval at 2 Hour Post Morning Dose (HPD 2) on Day 14
22 hrs prior to morning dose on Day 1 (Baseline for HPD 2), 2 hrs post morning dose on Day 14

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Change From Baseline in QT Interval at 4 Hour Post Morning Dose (HPD 4) on Day 14
20 hrs prior to morning dose on Day 1 (Baseline for HPD 4), 4 hrs post morning dose on Day 14

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Change From Baseline in QT Interval at 8 Hour Post Morning Dose (HPD 8) on Day 14
16 hrs prior to morning dose on Day 1 (Baseline for HPD 8), 8 hrs post morning dose on Day 14

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Change From Baseline in QT Interval at 12 Hour Post Morning Dose (HPD 12) on Day 14
12 hrs prior to morning dose on Day 1 (Baseline for HPD 12), 12 hrs post morning dose on Day 14

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated.QT interval: The time corresponding to the beginning of depolarization to repolarization of the ventricles.For each scheduled HPD, except for HPD=0, the time-matched baseline QT was defined as the mean of the triplicates on Day 0 at the same nominal HPD.

Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval
1, 2, 4, 8, 12 hrs post dose, additional 16 hrs post dose for 60 mg once daily group on Day 1; 1, 2 hrs post dose on Day 4, 7, 10;1,2,4,8,12 hrs post dose on Day 14; Day 21

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum increase from baseline of 30 to less than (\<) 60 msec(borderline) and greater than or equal to (\>=) 60 msec (prolonged) were summarized.

Number of Participants With Corrected QT (QTc) Interval Greater Than or Equal to 500 Millisecond
1, 2, 4, 8, 12 hrs post dose, additional 16 hrs post dose for 60 mg once daily group on Day 1; 1, 2 hrs post dose on Day 4, 7, 10;1,2,4,8,12 hrs post dose on Day 14; Day 21

Triplicate 12-lead ECG measurements (each recording separated by approximately 2 minutes) were performed and average was calculated. The time corresponding to beginning of depolarization to repolarization of the ventricles (QT interval) was adjusted for RR interval using QT and RR from each ECG by Fridericia's formula (QTcF = QT divided by cube root of RR) and by Bazette's formula (QTcB = QT divided by square root of RR). Participants with maximum QTc \>=500 msec were reported.

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 1
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1

AUCtau = area under the curve from time zero to end of dosing interval.

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) at Day 14
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14

AUCtau = area under the curve from time zero to end of dosing interval.

Maximum Observed Plasma Concentration (Cmax) at Day 1
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1
Maximum Observed Plasma Concentration (Cmax) at Day 14
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14
Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 1
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) at Day 14
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 14
Accumulation Ratio (R0)
0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 8, 12 hrs post dose on Day 1 and Day 14

Accumulation ratio was calculated as, R0 = area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1.

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 1
Baseline, 1 hr post-dose on Day 1

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 2
Baseline, hr 0 on Day 2

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 4
Baseline, hr 0 on Day 4

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 7
Baseline, hr 0 on Day 7

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 10
Baseline, hr 0 on Day 10

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 14
Baseline; hr 0, 8 hr post-dose on Day 14

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 18
Baseline, Hour 0 on Day 18

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 21
Baseline, hr 0 on Day 21

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 28
Baseline, hr 0 on Day 28

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Percent Change From Baseline in Fluorescence-Activated Cell Sorting (FACS) Analysis at Day 42
Baseline, hr 0 on Day 42

Absolute cell counts of cluster of differentiation 3 (CD3): T lymphocytes, cluster of differentiation 4 (CD4): Helper/Inducer T- Lymphocytes reactive with Major Histocompatability Complex-II (MHC-II), and cluster of differentiation 8 (CD8): Suppressor/Cytotoxic T-lymphocyte reactive with Major Histocompatability Complex-I (MHC-I), cluster of differentiation 16/56 (CD16/56): natural killer Cells, cluster of differentiation 19 (CD19): B-Lymphocytes determined using FACS.Baseline defined as mean of samples collected during screening, visit in which biopsy was taken, at Day 0 and at 0 hour Day 1.

Change From Baseline in Immune Cell Function at Day 14
Baseline (Within 7 days prior to Day 1), Day 14

The degree of immunosuppression induced by the study drug administration was evaluated using a bioluminescent assay in which the concentration of Adenosine-5-Triphosphate (ATP) released by CD4 cells was measured. ATP concentrations released from stimulated and unstimulated cells were evaluated. ATP Concentration less than or equal to (\<=) 225: low immune cell response, 226 to 524: Moderate immune cell response, \>= 525: strong immune cell response. Baseline was defined as the mean of the samples collected during the pre-dose biopsy.

Change From Baseline in Reticulocyte Count at Day 2
Baseline (Within 7 days prior to Day 1), Day 2

Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.

Change From Baseline in Reticulocyte Count at Day 4
Baseline (Within 7 days prior to Day 1), Day 4

Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.

Change From Baseline in Reticulocyte Count at Day 7
Baseline (Within 7 days prior to Day 1), Day 7

Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.

Change From Baseline in Reticulocyte Count at Day 10
Baseline (Within 7 days prior to Day 1), Day 10

Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.

Change From Baseline in Reticulocyte Count at Day 15
Baseline (Within 7 days prior to Day 1), Day 15

Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.

Change From Baseline in Reticulocyte Count at Day 21
Baseline (Within 7 days prior to Day 1), Day 21

Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.

Change From Baseline in Reticulocyte Count at Day 28
Baseline (Within 7 days prior to Day 1), Day 28

Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.

Change From Baseline in Reticulocyte Count at Day 42
Baseline (Within 7 days prior to Day 1), Day 42

Reticulocyte count was assessed to detect potential of Janus kinase 2 (JAK2) mediated erythropoiesis.

Time to Reach Maximum Change From Baseline and Time to Return to Baseline Value for Fluorescence-Activated Cell Sorting (FACS), Reticulocyte Counts and Immune Cell Function
Day 0 (pre-dose), 1, 2, 4, 7, 10, 14, 15, 18, 21, 28, 42
Half Maximal Effective Area Under the Concentration-Time Curve 50 (EAUC 50)
Day 14

EAUC 50 was calculated from a regression analyses using area under the concentration-time curve (AUC) as the independent variable. A sigmoid maximum effect (Emax) model was used to explain the relationship between AUC and modified Psoriasis Severity Index (mPASI) score, where Emax was the maximum effect (100 percent reduction in the total mPASI score from baseline), and EAUC 50 was the AUC where 50 percent of the maximum effect was measured.

Secondary Endpoints
Response by Mayo score
Outcome measured at induction Week 8, induction Week 16, and maintenance Week 44
Remission by Mayo score
Outcome measured at induction Week 8, induction Week 16, and maintenance Week 44
Change from baseline in Mayo score.
Outcome measured at induction Week 8, induction Week 16, and maintenance Week 44
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
tofacitinibEXPERIMENTALOpen label tofacitinib 5 mg BID weight based adult equivalent with the option for individual dose increase to 10 mg BID weight based adult equivalent for a limited time if dose escalation criteria are met, prior to returning to 5 mg BID.
Treatment Sequence AEXPERIMENTALTofacitinib 5 mg BID for 6 months
Treatment Sequence BPLACEBO_COMPARATORPlacebo for 3 months then tofacitinib 5 mg BID for 3 months
PlaceboPLACEBO_COMPARATOR -
tofacitinib modified release tabletEXPERIMENTAL -
tofacitinib immediate release tabletACTIVE_COMPARATOR -
Tofacitinib 5 mgBID x 12 monthsEXPERIMENTAL -
Tofacitinib 10 mg BID x 12 monthsEXPERIMENTAL -
Adalimumab 40 mg q2 weeks x 12 monthsACTIVE_COMPARATOR -
Placebo x3 months, then tofacitinib 5 mg BIDx 9 monthsPLACEBO_COMPARATOR -
Placebo x 3 months, then tofacitinib 10 mg BID x 9 monthsPLACEBO_COMPARATOR -
Treatment Sequence CPLACEBO_COMPARATORPlacebo for 3 months then tofacitinib 5 mg BID for 3 months
Treatment Sequence DPLACEBO_COMPARATORPlacebo for 3 months then tofacitinib 10 mg BID for 3 months
tofacitinib 10 mg BIDEXPERIMENTAL -
Placebo BIDPLACEBO_COMPARATOR -
Tofacitinib 5 mg BID (oral) (70 subjects)EXPERIMENTALZoster vaccine will be administered to subjects on background methotrexate; treatment with 5 mg tofacitinib twice daily will begin 2 to 3 weeks following vaccination and continue for 12 weeks.
Placebo tofacitinib BID (oral) (70 subjects)PLACEBO_COMPARATORZoster vaccine will be administered to subjects on background methotrexate; treatment with placebo twice daily will begin 2 to 3 weeks following vaccination and continue for 12 weeks.
Tofacitinib 2 mgEXPERIMENTAL -
Tofacitinib 5 mgEXPERIMENTAL -
Tofacitinib 10 mgEXPERIMENTAL -
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
15 mg BIDEXPERIMENTAL -
10 mg BIDEXPERIMENTAL -
3 mg BIDEXPERIMENTAL -
0.5 mg BIDEXPERIMENTAL -
Arm 1EXPERIMENTALSingle dose of 5 mL tofacitinib oral solution on Day 1 of Period 1 and Singe dose of 5 mg tofacitinib tablet on Day 1 of Period 2
Arm 2EXPERIMENTALSingle dose of 5 mg tofacitinib tablet on Day 1 of Period 1 and Singe dose of 5 mL tofacitinib oral solution on Day 1 of Period 2
Treatment A, separated washout phase, followed Treatment B.EXPERIMENTALTreatment A: Single oral dose of tofacitinib MR 11mg, administered as 1xMR 11mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7. washout phase: no later than 72 hours Treatment B: Two separate oral doses (12 hours apart) of tofacitinib IR 5mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7.
Treatment B, separated washout phase, followed Treatment A.EXPERIMENTALTreatment A: Single oral dose of tofacitinib MR 11mg, administered as 1xMR 11mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7. Washout phase: no later than 72 hours Treatment B: Two separate oral doses (12 hours apart) of tofacitinib IR 5mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7.
Tofacitinib MR 22 mg FedEXPERIMENTALSingle dose of tofacitinib MR 22 mg administered under fed conditions
Tofacitinib MR 22 mg FastedEXPERIMENTALSingle dose of tofacitinib MR 22 mg administered under fasted conditions
5 mg BIDEXPERIMENTAL5 mg BID for 13 days and once on Day 14
20 mg BIDEXPERIMENTAL20 mg BID for 13 days and once on Day 14
30 mg BIDEXPERIMENTAL30 mg BID for 13 days and once on Day 14
60 mg QDEXPERIMENTAL60 mg QD for 14 days
50 mg BIDEXPERIMENTAL50 mg BID x 13 days and once on day 14
Interventions
NameTypeDescription
tofacitinibDRUGOpen label tofacitinib 5 mg BID weight based adult equivalent with the option for individual dose increase to 10 mg BID weight based adult equivalent for a limited time if dose escalation criteria are met, prior to returning to 5 mg BID.
PlaceboOTHERtablets, to match tofacitinib 5 mg BID x 3 months
MethotrexateDRUGMethotrexate 7.5-20 mg weekly
Placebo MethotrexateDRUGPlacebo to match active methotrexate orally once a week
Tofacitinib 5 mg BIDDRUGTofacitinib orally (po) 1 tablet of 5 mg and placebo po 1 tablet BID x 12 months Placebo injections subcu every 2 weeks x 12 months
Tofacitinib 10 mg BIDDRUGTofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months
AdalimumabDRUGPlacebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months
Tofacitinib 2 mgDRUG4 blinded tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
Tofacitinib 5 mgDRUG4 blinded tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
Tofacitinib 10 mgDRUG4 blinded tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
(CP-6890,550) TofacitinibDRUG2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks
(CP-690,550) TofacitinibDRUG2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 weeks
CP- 690 550DRUGAdministration via oral route twice daily for the duration of treatment
Tofacitinib tabletDRUGSingle dose of tofacitinib 5 mg tablet
Tofacitinib Oral SolutionDRUGSingle 5 mL dose of tofacitinib oral solution (1 mg/mL)
tofacitinib MR 11 mgDRUGSingle oral dose of tofacitinib MR 11 mg, administered as 1 x MR 11 mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7.
tofacitinib IR 5 mgDRUGTwo separate oral doses (12 hours apart) of tofacitinib IR 5 mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7.
Tofacitinib MR 22 mg (Fed)DRUGA single dose of tofacitinib modified release 22 mg tablet after receiving the standard FDA high-fat/high-calorie meal
Tofacitinib MR 22 mg (Fasted)DRUGA single dose of tofacitinib modified release 22 mg tablet after an overnight fast of 10 hours
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Eligibility Criteria
Age Range2 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites69

Inclusion Criteria: * Evidence of a personally signed and dated informed consent document and assent document. * Males and females 2 to less than18 years old and weighing at least 10 kg. * Having a pathology report that confirms colonic inflammation consistent with UC with a clinical diagnosis of U...

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LOWJun 16, 2026NCT04624230lastUpdatePostDate: changed
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