Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Adalimumab (D2E7), Double-blind adalimumab, adalimumab (Humira), adalimumab (D2E7), Humira (adalimumab), Humira, Adalimumab (Humira)
Adalimumab · 56 trials · 16 indications
The proportion of patients with improvement in arthritis (DAS 28) at week 24 -changes from screening in DAS 28 , HAQ, , CRP. ANOVA analysis and descriptive statistics. An interim evaluation of the above parameters will be performed at week 16 (visit 4) and yearly afterwards for 3 more years in those patients who will continue drug study during the extension period
Improvement in the O'Leary Sant Symptom and Problem Index from baseline to week 12 Total scores on a scale range: 0-36 (0, meaning no symptoms to 36, meaning the most severe symptoms)
ASAS20 responder had improvement of 20% or more and absolute improvement of at least 10 units (on a scale of 0 \[least\] to 100 \[worst\]) from Baseline in at least 3 of the following 4 domains, with absence of deterioration (change for worse of at least 20% and net worsening of at least 10 units) in the potential remaining domain: Patient's Global Assessment of Disease Activity; Total Back Pain visual analog scale (VAS); Bath Ankylosing Spondylitis Functional Index (BASFI); and Inflammation (mean of 2 morning stiffness-related Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] scores).
Modified Total Sharp Score (mTSS) is a measure of joint health, used in evaluation of inhibition of radiographic progression of disease. Digitized X-rays of hands and feet were obtained then scored in a blinded manner: for erosions (0 \[no damage\] to 5 \[complete collapse or total destruction of joint\]) and for joint space narrowing (0 \[no damage\] to 4 \[complete luxation of joint\]). Scores were added, giving total mTSS (0 \[normal\] to 380 \[maximal disease\]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.
Response defined as at least 30% improvement in 3 or more of 6 juvenile rheumatoid arthritis (JRA) core set criteria, and at least 30% worsening in not more than 1 JRA criterion, compared with baseline. JRA core set criteria include physician's global assessment of disease severity; parent's/patient's global assessment of overall well-being; number of active joints (joints with swelling or with limitation of motion \[LOM\] and with pain, tenderness or both); number of joints with LOM; physical function of the Disability Index of Childhood Health Assessment Questionnaire; C-reactive protein.
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) subjects. ASAS has 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = at least 20% improvement (vs. baseline) and an absolute improvement ≥ 10 units on a 0 - 100 scale (0 = no disease activity; 100 = high disease activity) for ≥ 3 domains, and no worsening (defined as a worsening of ≥ 20% and a net worsening of ≥ 10 units) in the remaining domain.
The PGA is a 6-point scale used to measure the severity of a patient's disease. Plaque elevation, scaling, and erythema are rated from 0= clear (no plaque elevation; no scaling; erythema=hyperpigmentation, pigmented macules, diffuse faint pink or red coloration) to 5=very severe (plaque elevation=very marked; scaling=very coarse; erythema=very severe \[extreme red coloration, dusky to deep red coloration\]).
Serious adverse events were collected from the time of informed consent, and nonserious adverse events were collected from the time of first dose of adalimumab, until 70 days after the last injection of adalimumab. Refer to the Reported Adverse Events section of this results disclosure for specific adverse events reported. Note: Severe events considerably interfered in patients' usual activities and may have been life-threatening. Serious events were life-threatening; resulted in hospitalization, congenital anomalies, or disability; or required intervention to prevent seriousness.
Physical examination findings were compared between Baseline and Week 24, and changes were recorded (Normal at Baseline to Abnormal at Week 24; or Abnormal at Baseline to Normal at Week 24). Physical examination criteria (normal vs. abnormal) were at the clinical judgement of the examining physician. Significant changes in physical examination from Baseline were considered to be adverse events.
Laboratory values were assessed for values above and below the normal (reference) ranges used by the central laboratory. Note abbreviations used in table: Alk. phosphatase = alkaline phosphatase, ALT = alanine aminotransferase, AST = aspartate aminotransferase, ESR = erythrocyte sedimentation rate
Vital signs values were assessed for values above and below the normal (reference) ranges used by the central laboratory. Note, in table, BP = blood pressure.
Comparison of adalimumab 80 mg monthly dose versus placebo and adalimumab 40 mg eow in the number of responders with ACR criteria improvement consisting of 20%, (ACR20) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20% improvement in 3 of the following 5 criteria: \[1\] physician's global assessment of disease activity (PGA), \[2\] subject's assessment of disease activity, \[3\] subject's assessment of pain, \[4\] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and \[5\] C-reactive protein (CRP) at each visit
PASI75 is defined as at least a 75% reduction in PASI (Psoriasis Area and Severity Index) score compared with the Baseline PASI score. PASI scores range from 0.0 (best) to 72.0 (worst), with the highest score representing complete erythroderma of the severest degree. The percent decrease in score is calculated as (Week 0 PASI score minus Week 16 PASI score) divided by Week 0 PASI score. Positive percent decreases indicate improvement, with best improvement being 100%. The outcome measure is the percentage of participants who had at least a 75% PASI score decrease.
PASI 75 is a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI). The PASI scale runs from 0-72, where 0 = no psoriasis and 72 = complete erythroderma of the severest possible degree
Pediatric Crohn's Disease Activity Index (PCDAI) is an index used to measure disease activity of pediatric patients with Crohn's Disease assessing abdominal pain, stool frequency, patient functioning, hematocrit, erythrocyte sedimentation rate, albumin, weight, height, abdomen, perirectal disease, and extraintestinal manifestations. It ranges from 0 to 100; higher scores indicate more active disease. The primary endpoint was clinical remission as defined by PCDAI score ≤ 10. The comparison was between High-Dose adalimumab versus Low-Dose adalimumab in the intent-to-treat population.
Extent of exposure for all adalimumab treated subjects
Extent of exposure for all adalimumab treated subjects
Treatment compliance (%) = 100 \* (Number of doses of study medication actually received)/(Number of doses planned during the subject's participation in the study).
5-items that assess general well-being, abdominal pain, diarrhea, abdominal mass, and complications. Score is total of 1) subject well-being (0=very well; 4=terrible); 2) abdominal pain (0=none; 3=severe); 3) diarrhea (number of time per day); 4) abdominal mass (0=none; 3=definite and tender); 5) complications (number). Maximum total score for HBI is not specified, is dependent on number of diarrhea times each day and number of complications. Clinical remission = HBI less than 5. Highest total score at Baseline was 47. Missing data were imputed using non-responder imputation (NRI).
Clinical remission per Mayo score is defined as a total Mayo score \<= 2 and no individual subscore \> 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: Stool Frequency Subscore, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease).
Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: Stool Frequency Subscore (SFS), Rectal Bleeding Subscore (RBS), Endoscopy Subscore, and Physician's Global Assessment Subscore (PGA), each of which ranges from 0 (normal) to 3 (severe disease).
Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease).
Subjects were to have undergone up to 4 endoscopies to evaluate the presence or absence of mucosal ulceration: at Screening, at Week 12 (subjects who moved to open label (OL) drug between Week 8 and Week 12 because of disease flare or non-response were evaluated by endoscopy prior to receiving OL dosing), at the time of switch from blinded study drug to OL adalimumab at any time after Week 12, and at Week 52 or Early Termination. Subjects who remained blinded for the entire 52-week trial or switched to OL adalimumab between Week 8 and Week 12 were to have undergone 3 endoscopies.
Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: \[1\] physician's global assessment of disease activity (PGA), \[2\] subject's assessment of disease activity, \[3\] subject's assessment of pain, \[4\] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and \[5\] C-reactive protein (CRP) at each visit.
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of \< 150. The CDAI is a weighted composite score of 8 clinical factors measured over a 1-week period. A lower CDAI score indicates lesser disease severity.
Number of responders with ACR criteria improvement consisting of 20%, 50%, and 70% (ACR20/50/70, respectively) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: 1) physician's global assessment of disease activity (PGA), 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire (DI-HAQ), and 5) C-reactive protein (CRP) at each visit.
The Physician's Global Assessment \[PGA\] was scored by the physician using a 6-point scale (0-5) for the degree of overall lesion severity, where 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, and 5 = very severe. Subjects with a PGA of Clear or Minimal overall lesion severity had scores of 0 or 1.
ASAS 20 responders - improvement of \>=20% and absolute improvement of \>=10 units from Baseline in a visual analog scale (VAS) for \>=3 of 4 domains; Patient's Global Assessment of disease activity VAS (0 \[none\]-100 \[severe\]), Total Back Pain VAS (0 \[no pain\]-100 \[severe\]), BASFI VAS (0 \[easy\]-100\[impossible\]); and Inflammation VAS (0 \[none\]-10 \[very severe\]) and absence of deterioration in the potential remaining domain, defined as a worsening of \>=20% and a net worsening of \>=10 units. Applied to each scale and not to an overall global scale.
Radiographic progression was based on change in mSASSS scoring (comparison of the means) from double-blind Baseline visit to Week 104. The mSASSS is the sum of the lumbar and cervical spine score ( 0 \[no change\] to 72 \[progression\]), derived from scoring the anterior site of the lumbar spine (T12 to S1) and the cervical spine (C2 to T1) as either 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), 3 (bridging syndesmophyte), or N (vertebral body not evaluable). Data from NCT00195819 was compared with data from AS patients in OASIS.
ASAS 20 responders - improvement of \>=20% and absolute improvement of \>=10 units from Baseline in a visual analog scale (VAS) 0 \[no disease activity\]-100 \[high disease activity\]) for \>=3 of 4 domains; Patient's Global Assessment of disease activity VAS; (0\[none\]-100 \[severe\]), Total Back Pain VAS; (0 \[no pain\]-100 \[severe\]), BAth Ankylosing Spondylitis Functional Index (BASFI) VAS (0 \[easy \]-100\[impossible\]); and Inflammation VAS; (1 \[no pain\] to 10 \[severe pain\]) and absence of deterioration in the potential remaining domain. Applied to each scale and not to an overall global scale.
ACR20 response criteria were: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient 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 (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.
ACR20 response criteria were: \>=20% improvement in tender joint count; \>=20% improvement in swollen joint count; and \>=20% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient 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 (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.
ACR50 response criteria were: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient 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 (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.
ACR50 response criteria were: \>=50% improvement in tender joint count; \>=50% improvement in swollen joint count; and \>=50% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient 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 (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.
ACR70 response criteria were: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient 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 (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.
ACR70 response criteria were: \>=70% improvement in tender joint count; \>=70% improvement in swollen joint count; and \>=70% improvement in at least 3 of the 5 remaining ACR core measures: patient assessment of pain; patient 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 (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response). All improvements were assessed relative to the baseline of the prior study.
Clinical remission on modified Disease Activity Score (DAS28) was a value \<2.6; \>=2.6 to \<=3.2 indicated low disease activity; \>3.2 to \<=5.1 indicated moderate disease activity; and \>5.1 indicated high disease activity. DAS28 score is calculated using the number of tender joints and swollen joints (out of 28 each), patient global assessment of disease activity, and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response).
Clinical remission on modified Disease Activity Score (DAS28) was a value \<2.6; \>=2.6 to \<=3.2 indicated low disease activity; \>3.2 to \<=5.1 indicated moderate disease activity; and \>5.1 indicated high disease activity. DAS28 score is calculated using the number of tender joints and swollen joints (out of 28 each), patient global assessment of disease activity, and C-reactive protein (a laboratory marker of inflammation that is sensitive to acute changes in inflammatory response).
The HAQ-DI is a measure of disability that ranges from 0 to 3. Decrease in score indicates improvement in physical function; a decrease of 0.22 or greater from Baseline score is clinically significant. Participants assessed their ability to perform at least 6 of the following 8 specific tasks (1. dress/groom; 2. arise; 3. eat; 4. walk; 5. reach; 6. grip; 7. maintain hygiene; 8. maintain daily activity) over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The 8 task scores are added and the sum is divided by the number of tasks assessed (range = 6 to 8). This yields a HAQ-DI score of 0 to 3.
The HAQ-DI is a measure of disability that ranges from 0 to 3. Decrease in score indicates improvement in physical function; a decrease of 0.22 or greater from Baseline score is clinically significant. Participants assessed their ability to perform at least 6 of the following 8 specific tasks (1. dress/groom; 2. arise; 3. eat; 4. walk; 5. reach; 6. grip; 7. maintain hygiene; 8. maintain daily activity) over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). The 8 task scores are added and the sum is divided by the number of tasks assessed (range = 6 to 8). This yields a HAQ-DI score of 0 to 3.
Patients were responders if they had: \>= 20% improvement in tender joint count; \>= 20% improvement in swollen joint count; and \>= 20% improvement in at least 3 of 5 remaining ACR core measures: patient assessment of pain; patient global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]); and acute phase reactant: C-reactive protein. Patients withdrawing early or receiving additional disease-modifying anti-rheumatic drugs (DMARDs) after Week 16 were non-responders.
Modified total Sharp x-ray score (mTSS) is a measure of change in joint health. Radiographs of hands/wrists and feet were obtained at screening and Week 52. Digitized images of these were scored in a blinded manner. Joints were scored for erosions from 0 (no damage) to 5 and for joint space narrowing from 0 (no damage) to 4; scores were added to obtain the mTSS (range = 0 \[normal\] to 398 \[maximal disease\]). Large positive change indicates disease progression; small positive/no change indicates slowing/halting of disease progression; and negative change may indicate improvement of disease.
Subjects assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Subjects assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ indicated improvement.
Number in remission at 24 weeks (absence of clinical-evidence synovitis (no tender/swollen joints) \& CRP\< 5mg/ml)
Clinical response is defined as a Physician's Global Assessment (PGA) of clear, minimal, or mild (scores of 0, 1, or 2) with a minimum of 2 grades improvement (reduction) from baseline. PGA is a physician's assessment of the severity of disease based on a 6-point scale (score of 0 = clear and 5 = very severe).
American College of Rheumatology (ACR) criteria improvement consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-Blind period.
Clinical remission=Crohn's Disease (CD) Activity Index (CDAI) \<150; number of soft stools, abdominal pain, general well-being, presence of 6 signs (arthritis/arthralgia; iritis/uveitis; erythema nodosum/pyoderma gangrenosum/aphthous stomatitis; fissure, abscess, anal fistula; other cutaneous fistula; fever over 100 degrees), taking medication for diarrhea, abdominal mass, hematocrit, and weight loss are documented during 1-week assessment period. CDAI total score is \>= 0 and without upper limit. Low score=less severe CD activity. Decrease indicates improvement.
CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Comparison of the number of subjects with a clinical remission (CDAI \< 150) in the adalimumab 160 mg (Week 0)/ 80 mg (Week 2) and adalimumab 80 mg (Week 0)/ 40 mg (Week 2) groups at Week 4.
PASI scores range from 0 (best outcome) to 72 (worst outcome including erythema, induration, desquamation, and area affected). Baseline is defined as the last available PASI value prior to the first dose of study drug (adalimumab or placebo) in Study M04-688 (NCT00338754).
Number of subjects with American College of Rheumatology (ACR) criteria improvement consisting of 20%, 50%, and 70% (ACR20, ACR50, and ACR70, respectively) reduction in tender or swollen joint counts \[TJC or SJC, respectively\] and 20%, 50%, and 70% improvement, respectively, in 3 of the following 5 criteria: \[1\] physician's global assessment of disease activity \[PGA\], \[2\] subject's assessment of disease activity, \[3\] subject's assessment of pain, \[4\] subject's assessment of functional disability via a health assessment questionnaire \[HAQ\], and \[5\] C-reactive protein \[CRP\]) at each visit
| Arm | Type | Description |
|---|---|---|
| Adalimumab, Behcet with arthritis | EXPERIMENTAL | - |
| adalimumab | EXPERIMENTAL | Adalimumab 80mg subcutaneous loading dose followed by 40 mg subcutaneous every 2 weeks for 12 weeks |
| Inactive drug | PLACEBO_COMPARATOR | Placebo in identical syringe subcutaneous every 2 weeks for 12 weeks |
| methotrexate + adalimumab | EXPERIMENTAL | Methotrexate and intraarticular triamcinolone hexacetonide plus adalimumab. |
| methotrexate + placebo | PLACEBO_COMPARATOR | Methotrexate and intraarticular triamcinolone hexacetonide and placebo |
| Placebo | PLACEBO_COMPARATOR | Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 24. |
| DB Placebo | PLACEBO_COMPARATOR | Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly. |
| DB adalimumab | EXPERIMENTAL | Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly. |
| DB Adalimumab/OL Adalimumab | EXPERIMENTAL | Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly. |
| DB Placebo/OL Adalimumab | EXPERIMENTAL | Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly. |
| DB Adalimumab/RE OL Adalimumab | EXPERIMENTAL | Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly. |
| DB Placebo/RE OL Adalimumab | EXPERIMENTAL | Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible at Week 12 or after) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly. |
| Open Label | EXPERIMENTAL | - |
| 40 mg | ACTIVE_COMPARATOR | 40 mg every other week |
| 80 mg | ACTIVE_COMPARATOR | 80 mg monthly |
| adalimumab + placebo | ACTIVE_COMPARATOR | adalimumab + placebo (vehicle ointment) |
| adalimumab + calcipotriol/betamethasone | ACTIVE_COMPARATOR | adalimumab + calcipotriol/betamethasone ointment |
| 1 | EXPERIMENTAL | - |
| Open-label adalimumab (Week 0 to Week 4) | ACTIVE_COMPARATOR | All subjects received an open-label adalimumab induction regimen. Subjects weighing greater than or equal to 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing less than 40 kg at Baseline received 80 mg at Week 0 and 40mg at Week 2. |
| Low-Dose Adalimumab: 20 mg or 10 mg eow (Week 4 to Week 52) | ACTIVE_COMPARATOR | Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy. |
| High-Dose Adalimumab: 40 mg or 20 mg eow (Week 4 to Week 52) | ACTIVE_COMPARATOR | Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight \[BW\] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy. |
| Adalimumab 80/40 | EXPERIMENTAL | - |
| Adalimumab 160/80/40 | EXPERIMENTAL | - |
| adalimumab group | EXPERIMENTAL | - |
| placebo group | EXPERIMENTAL | - |
| Double Blind | PLACEBO_COMPARATOR | Blinded study through Week 52. Adalimumab compared to placebo during blinded portion. |
| A | ACTIVE_COMPARATOR | - |
| B | ACTIVE_COMPARATOR | - |
| C | PLACEBO_COMPARATOR | - |
| Adalimumab 40 mg every other week (eow) | EXPERIMENTAL | - |
| DB adalimumab 20 mg ew | EXPERIMENTAL | Subjects received 20 mg adalimumab subcutaneously (SC) once weekly (ew) and concomitant methotrexate (MTX) during the double-blind (DB) phase. |
| DB adalimumab 40 mg eow | EXPERIMENTAL | Subjects received 40 mg adalimumab subcutaneously (SC) every other week (eow) and concomitant methotrexate (MTX) during the double-blind (DB) phase. Subjects received placebo injections SC and concomitant MTX on the alternate weeks during the DB phase. |
| DB placebo ew | PLACEBO_COMPARATOR | Subjects received placebo subcutaneously (SC) once weekly (ew) and concomitant methotrexate (MTX) during the double-blind (DB) phase. |
| DB adalimumab 20 mg ew/OL adalimumab 40 mg eow | EXPERIMENTAL | Subjects received adalimumab 20 mg subcutaneously (SC) once weekly (ew) during the double-blind (DB) phase, then adalimumab 40 mg SC every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX). |
| DB adalimumab 40 mg eow/OL adalimumab 40 mg eow | EXPERIMENTAL | Subjects received adalimumab 40 mg subcutaneously (SC) every other week (eow) with placebo on alternate weeks during the double-blind (DB) phase, then adalimumab 40 mg SC eow during the open-label (OL) extension phase, along with concomitant methotrexate (MTX). |
| DB placebo ew/OL adalimumab 40 mg eow | EXPERIMENTAL | Subjects received placebo subcutaneously (SC) once weekly (ew) during the double-blind phase, then adalimumab 40 mg SC every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX). |
| TNF-antagonist | EXPERIMENTAL | Adalimumab, 40 mg, 2-weekly Methotrexate, rapid escalation to 25mg, weekly Folic Acid 5mg, 6 days a week |
| Placebo + MTX | ACTIVE_COMPARATOR | Placebo, 2 weekly Methotrexate, rapid escalation to 25mg, weekly Folic Acid 5mg, 6 days a week |
| Adalimumab 40 mg qwk | EXPERIMENTAL | Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15. |
| Adalimumab 40 mg eow | EXPERIMENTAL | Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15. |
| Adalimumab 80 mg | EXPERIMENTAL | Adalimumab 80 mg administered subcutaneously every other week |
| Adalimumab 40 mg | EXPERIMENTAL | Adalimumab 40 mg administered subcutaneously every other week |
| Placebo eow | PLACEBO_COMPARATOR | Subjects received placebo subcutaneously (SC) every other week (eow) during the double-blind treatment period lasting 52 weeks. |
| OL Adalimumab 40 mg eow | EXPERIMENTAL | Subjects received open-label (OL) 40 mg adalimumab subcutaneously (SC) every other week (eow) during the double-blind treatment period lasting 52 weeks. |
| Adalimumab 160 mg/80 mg | EXPERIMENTAL | - |
| Adalimumab 80 mg/40 mg | EXPERIMENTAL | - |
| Adalimumab 40 mg every other week | EXPERIMENTAL | - |
| Adalimumab 80 mg every other week | EXPERIMENTAL | - |
| 20 mg | EXPERIMENTAL | 20 mg adalimumab eow |
| Name | Type | Description |
|---|---|---|
| Adalimumab (Humira) | DRUG | Open label pilot trial. The study includes 3 phases : 1. Open label treatment period of 24 weeks. 2. Extension follow -up (3 years): Patients who responded well to study drug and their disease relapsed within the first 12 weeks following study drug interruption will be eligible to receive the study drug for 3 years in order to comply with the Israeli Ministry of Health requirements. 3. Safety follow-up: For patients who withdraw from either the open label treatment period or extension period, for another 24 weeks. |
| Adalimumab | DRUG | 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period |
| inactive drug | OTHER | 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period |
| Placebo | DRUG | Saline injection 0.9%, 0.8 ml s.c. every second week up to 2 years |
| Double-blind adalimumab | BIOLOGICAL | Double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) |
| Double-blind Placebo | DRUG | Double-blind adalimumab-matching placebo administered subcutaneously (SC)every other week (eow) |
| Open-label Adalimumab | BIOLOGICAL | Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) after completion of the first 26 weeks in the study |
| Open-labelAdalimumabRescue | BIOLOGICAL | Open-label adalimumab 40 mg administered subcutaneously (SC) every other week (eow) as rescue treatment to complete the first 26 weeks in the study- dependent on participant eligibility (increase in disease activity), applies to Weeks 12 to 26 |
| Calcipotriol/Betamethasone Ointment | DRUG | Topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mcg/g) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16 |
| placebo (vehicle ointment) | DRUG | Topical vehicle ointment (matching active calcipotriol/betamethasone ointment) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16 |
| Humira (adalimumab) | BIOLOGICAL | Study drug will be provided as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). Loading dose of 80 mg of adalimumab subcutaneously (sc) at Baseline, and 40 mg of adalimumab sc at Week 1, followed by 40 mg of adalimumab sc every other week (eow) for 24 weeks. |
| MTX | DRUG | MTX 7.5 to 25 mg once weekly |
| placebo adalimumab, placebo MTX | DRUG | placebo injections once every other week after 2 injections at Baseline (adalimumab) placebo capsules once weekly (MTX) |
| adalimumab (D2E7) | BIOLOGICAL | Adalimumab 40 mg every other week, subcutaneous |
| Methotrexate | DRUG | - |
| placebo for adalimumab | DRUG | placebo eow Week 0 - Week 12 |
| Folic Acid | DRUG | - |
| Adalimumab 80 mg | BIOLOGICAL | Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks. |
| Adalimumab 40 mg | BIOLOGICAL | Adalimumab 40 mg administered subcutaneously every other week for 104 weeks |
Inclusion Criteria: 1. Able and willing to give written informed consent and comply with the requirements of the study protocol. 2. Patients with Behcet disease ,who fulfilled the International Study group criteria for Behcet Disease. 3. Experienced an inadequate response to previous or current tre...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY002-072 |
| XBiotech, Inc. | XBIT | 1 | PHASE2 | vilamakitug |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Upadacitinib |
| Novartis AG Sponsored ADR | NVS | 1 | - | Secukinumab |
| Pfizer Inc. | PFE | 1 | - | Tofacitinib |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
Humira is a monoclonal antibody used for the treatment of psoriasis. It is being developed by Abbott Laboratories for this dermatological condition. In clinical trials, Humira has been studied as an add-on therapy for patients with psoriasis who have had an inadequate response to their current treatment.
Humira is a monoclonal antibody that targets tumor necrosis factor-alpha (TNF-alpha). By binding to TNF-alpha, Humira is designed to block its activity, which is involved in the inflammatory process of psoriasis. This mechanism is intended to reduce the signs and symptoms of the condition.
Humira is developed by Abbott Laboratories, a company traded under the ticker symbol ABT. The company is conducting clinical research on Humira for the treatment of psoriasis, with a completed Phase 3 trial evaluating its use in this indication.
Humira is in Phase 3 clinical development for the treatment of psoriasis. A Phase 3 trial, identified as NCT00513370, has been completed. This trial was an open-label, uncontrolled study that enrolled 203 participants in Canada. Humira is still considered investigational for this use.
Humira has one completed clinical trial for psoriasis, registered as NCT00513370. This Phase 3 study was titled "A Canadian Open-Label Access Program to Evaluate Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis." The trial enrolled 203 adults aged 18 years and older in Canada.
Yes, Humira is the same as adalimumab. The clinical trial for Humira in psoriasis, NCT00513370, specifically evaluates adalimumab, which is the scientific name for Humira. This alternative name is used in the trial title and is important for identifying the drug in medical literature.