Recent Updates
Recently added Catalysts

CP 690,550 solutions

Phase 3

Arthritis, Rheumatoid | Small molecule | Musculoskeletal |Pfizer, Inc.|Last Updated: May 16, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials10
Total Enrollment9,021
FDA Designations
No designations recorded
Clinical Trials (10)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01039688Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTXPHASE3 COMPLETED 956Jan 1, 2010Mar 1, 2013Apr 6, 2018176 United States, Argentina +28
NCT00960440Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) InhibitorsPHASE3 COMPLETED 399Oct 1, 2009Mar 1, 2011Dec 19, 201892 United States, Australia +12
NCT00856544A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis MedicationsPHASE3 COMPLETED 795May 1, 2009Jan 1, 2011Jan 10, 2013133 United States, Australia +18
NCT00847613A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background MethotrexatePHASE3 COMPLETED 800Mar 1, 2009Feb 1, 2012May 16, 2024115 United States, Australia +13
NCT00814307A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid ArthritisPHASE3 COMPLETED 611Feb 1, 2009Jun 1, 2010Jan 18, 201395 United States, Brazil +14
NCT00413699Long-Term Effectiveness And Safety Of CP-690,550 For The Treatment Of Rheumatoid ArthritisPHASE3 COMPLETED 4,488Feb 5, 2007Oct 26, 2017Oct 30, 2018469 United States, Argentina +41
NCT00687193Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In JapanPHASE2 COMPLETED 318Mar 1, 2009Jul 1, 2010Mar 25, 201340 Japan
NCT00603512Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in JapanPHASE2 COMPLETED 140Jan 1, 2008Sep 1, 2008Jan 25, 201318 Japan
NCT00413660Comparison Of 6 CP-690,550 Doses Vs.Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid ArthritisPHASE2 COMPLETED 509Jan 1, 2007Aug 1, 2008Jan 18, 201382 United States, Argentina +11
NCT01023100A Study Of The Taste Of Different Oral Liquid Preparations Of CP-690,550 In Trained Adult Product TestersPHASE1 COMPLETED 5Mar 1, 2010Mar 1, 2010Jun 16, 20101 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Modified Total Sharp Score (mTSS) at Month 6
Month 6

mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score).

Change From Baseline at Month 6 in mTSS
Month 6

mTSS: sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores range from 0 (normal) to 448 (worst possible total score). An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.

Percentage of Participants Achieving American College of Rheumatology 70 (ACR70) Response at Month 6
Month 6

ACR70 response: greater than or equal to (≥) 70 percent (%) improvement in tender joints count (TJC) or swollen joints count (SJC) and ≥70% improvement in at least 3 of 5 remaining ACR core measures: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability (disability index of the Health Assessment Questionnaire \[HAQ\]), and 5) C-reactive protein (CRP).

Absolute Blood Pressure (BP) Values (mmHg)
Baseline and Months 1, 2, 3, 6, 9, 12, 15, 18, and 24

BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.

Change From Baseline in BP Values (mmHg)
Months 1, 2, 3, 6, 9, 12, 15, 18, and 24

BP: pressure exerted by the blood upon the walls of the blood vessels and especially arteries, usually measured on the radial artery using a sphygmomanometer. Systolic BP: the highest arterial blood pressure of a cardiac cycle occurring immediately after systole of the left ventricle of the heart. Diastolic BP: the lowest arterial blood pressure of a cardiac cycle occurring during diastole of the heart.

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 3
Month 3

ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joints count (TJC); \>= 20% improvement in swollen joints count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.

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

HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities:dress/groom;arise;eat; walk;reach;grip; hygiene;common activities over past week. Each item scored on 4-point scale from 0-3:0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Overall score was computed as sum of domain scores and divided by number of domains answered. Total possible score range 0-3:0=least difficulty and 3=extreme difficulty. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.

Percentage of Participants With Disease Activity Score Based on 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3
Month 3

DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR)(millimeter/hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (\<=)3.2 implied low disease activity, greater than (\>)3.2 to 5.1 implied moderate to high disease activity, less than (\<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 3 analysis.

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 6
Month 6

ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.

Percentage of Participants Achieving Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])Less Than 2.6 at Month 6
Month 6

DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeters/hour\[mm/hour\]) and patient's global assessment (PtGA) of disease activity(participant rated arthritis activity assessment). Total score range:0-9.4, higher score=more disease activity. DAS28-4 (ESR) less than or equal to (\<=)3.2 implied low disease activity, greater than (\>)3.2 to 5.1 implied moderate to high disease activity, less than (\<)2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.

Changes From Baseline in Modified Total Sharp Score (mTSS) at Month 6
Baseline, Month 6

mTSS = sum of erosion and Joint Space Narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change: scores at observation minus score at baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.

Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 6
Month 6

DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=\<) 3.2 implied low disease activity, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity and less than (\<) 2.6=remission. For comparison of CP-690,550 with placebo, placebo sequences were combined into single reporting group for Month 6 analysis.

Percentage of Participant With Disease Activity Score Using 28-Joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) Less Than 2.6 at Month 3
Month 3

DAS28-4 (ESR) calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joint count, erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (transformed score ranging 0 to 10; higher score indicated greater affectation due to disease activity). Total score range:0 to 9.4, higher score indicated more disease activity. DAS28-4 (ESR) less than or equal to (=\<) 3.2 implied low disease activity, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity and less than (\<) 2.6=remission.

Initial Period: Primary Endpoints Were Standard Laboratory Safety Data (Chemistry, Hematology, Etc.) and Adverse Event (AE) Reports
Includes laboratory test abnormality data for all visits and adverse event data up to 999 days after last dose of study drug

Treatment-emergent non serious AEs by System Organ Class (SOC) (all causalities) and Laboratory Test Abnormalities (without regard to baseline) The stated number of participants analyzed was the total number of participants in each group (AEs). The actual number of participants analyzed for each laboratory parameter varied, and is provided for each. Abs=absolute; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ESR=erythrocyte sedimentation rate; GGT=gamma glutamyl transferase; hgb=hemoglobin; HDL=high density lipids; LDL=low density lipids; LLN=lower limit of normal; qual=qualitative; Tot=total; ULN=upper limit of normal; WBC=white blood cell

Extension Period: Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs)
Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)

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. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.

Extension Period: Number of Participants With Laboratory Test Abnormalities
Baseline (Day 1 at Entry of Extension Period) up to 28 days after last study drug dose in Extension Period (13 Months)

Criteria for laboratory abnormalities: hemoglobin (Hg), hematocrit, red blood cell (RBC), high density lipoprotein (HDL) cholesterol:\<0.8\*lower limit of normal (LLN), platelet\<0.5\*LLN/\>1.75\*upper limit of normal (ULN), white blood cell (WBC)\<0.6\*LLN/\>1.5\*ULN, lymphocyte, neutrophil, protein, albumin \<0.8\*LLN/\>1.2\*ULN, basophil, eosinophil, monocyte, low density lipoprotein (LDL) cholesterol: \>1.2\*ULN; bilirubin\>1.5\*ULN, aspartate amino transferase(AT), alanine AT, gammaglutamyl transferase, alkaline phosphatase:\>3.0\*ULN; blood urea nitrogen, creatinine, cholesterol, triglyceride:\>1.3\*ULN; sodium \<0.95\*LLN/\>1.05\*ULN, potassium, chloride, calcium, bicarbonate: \<0.9\*LLN/\>1.1\*ULN; glucose\<0.6\*LLN/\>1.5\*ULN; Urine (specific gravity\<1.003/\>1.030, pH\<4.5/\>8, glucose, ketone, protein, blood/Hg(\>=1; RBC, WBC\>=20; creatinine kinase\>2\*ULN).

Initial Period: The Long Term Safety and Tolerability of CP-690,550 5 Milligrams (mg) Twice Daily (BID) and 10 mg BID for the Treatment of Rheumatoid Arthritis
Includes AEs for every visit and up to 999 days after last dose of study drug

Treatment-emergent AEs by SOC (all causalities) - all participants, by time. Data presented for Post Month 96 includes data up to and including Month 114.

Extension Period: Percentage of Participants With Adverse Events and Who Discontinued Treatment Due to Adverse Events to Assess Long-term Safety and Tolerability of Tofacitinib
Baseline (Day 1 at Entry of Extension Period) up to Month 6 of Extension Period; Month 6 of Extension Period to Month 12 of Extension Period

Long term safety and tolerability of Tofacitinib was measured as following: percentage (%) of participants with AEs, percentage of participants who discontinued due to AEs. An AE is any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship.

Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12
Week 12

ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in painful and tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 12
Week 12

ACR20 response: greater than or equal to (\>=) 20 percent (%) improvement in tender joint count (TJC); \>= 20% improvement in swollen joint count (SJC); and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).

A complete description of the sensory attributes of products (eg, aroma, flavor, texture, and mouthfeel).
3 months
Secondary Endpoints
mTSS Score at Baseline, Months 12 and 24
Baseline, Months 12 and 24
Change From Baseline in mTSS Score at Months 12 and 24
Months 12 and 24
Percentage of Participants With no Progression in mTSS at Months 6, 12, and 24
Months 6, 12, and 24
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
5 mg BID CP-690,550EXPERIMENTAL -
10 mg BID CP-690,550EXPERIMENTAL -
methotrexateACTIVE_COMPARATOR -
Sequence 1EXPERIMENTAL -
Sequence 2EXPERIMENTAL -
Sequence 3PLACEBO_COMPARATOR -
Sequence 4PLACEBO_COMPARATOR -
Active 5 mgEXPERIMENTAL -
Active 10 mgEXPERIMENTAL -
Placebo Sequence 1PLACEBO_COMPARATORPlacebo non-responders advance to 5 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 5 mg CP-690,550 at Month 6 visit.
Placebo Sequence 2PLACEBO_COMPARATORPlacebo non-responders advance to 10 mg CP-690,550 at Month 3 visit. All patients in this treatment arm advance to 10 mg CP-690,550 at Month 6 visit.
Active 5mgEXPERIMENTAL -
Open-Label Active Treatment Enrolled from Phase 2EXPERIMENTALPatients enrolling from Phase 2 studies
Open-Label Active Treatment Enrolled from Phase 3EXPERIMENTALPatients enrolling from Phase 3 studies
PlaceboPLACEBO_COMPARATOR -
CP-690,550, 10mgEXPERIMENTAL -
CP-690,550, 15mgEXPERIMENTAL -
CP-690,550, 1mgEXPERIMENTAL -
CP-690,550, 3mgEXPERIMENTAL -
CP-690,550, 5mgEXPERIMENTAL -
CP-690,550, 0mgPLACEBO_COMPARATOR -
CP 690,550 1 mg BIDEXPERIMENTAL -
CP 690,550 10 mg BIDEXPERIMENTAL -
CP 690,550 15 mgEXPERIMENTAL -
CP 690,550 3 mg BIDEXPERIMENTAL -
CP 690,550 5 mg BIDEXPERIMENTAL -
CP-690,550 20 mg QDEXPERIMENTAL -
Open labelEXPERIMENTAL -
Interventions
NameTypeDescription
CP-690,550DRUGOral tablets administered at a dose of 5 mg BID for 24 months
Disease-modifying antirheumatic drugDRUGOral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months
PlaceboDRUGOral placebo tablets administered BID daily during the first 3 months of the double-blind, study period.
CP 690,550 oral solutionsDRUGflavored and unflavored prototype CP-690,550 formulations
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites176

Inclusion Criteria: * Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated with methotrexate. * Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria. * Active disease as defined by both \>=6 tender or painful joints on motion and \>= 6 jo...

Countries:United StatesArgentinaAustraliaBelgiumBrazilBulgariaCanadaChileColombiaCosta RicaCzechiaDominican RepublicGermanyHungaryIndiaMalaysiaMexicoNew ZealandPeruPhilippinesPolandPuerto RicoRussiaSlovakiaSouth KoreaSpainSwedenTaiwanThailandUkraineAustriaFranceIrelandItalyChinaCroatiaDenmarkFinlandGreeceUnited KingdomVenezuelaJapanBosnia and HerzegovinaRomaniaTurkey (Türkiye)
Unlock Eligibility Criteria