- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02281552
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
March 12, 2018 updated by: Pfizer
A Multicenter, Randomized, Double-blind, Parallel-group, Phase 3 Study To Demonstrate Non-inferiority For The Efficacy Of A Once Daily Dose Of Tofacitinib Modified Release Tablet To A Twice Daily Dose Of The Immediate Release Tablet In Adult Patients With Rheumatoid Arthritis On Background Methotrexate
This is a 12 week study that will evaluate the efficacy and safety of the 11 mg tofacitinib modified release tablet taken once a day in patients with rheumatoid arthritis who continue taking methotrexate.
Results for the modified release tablets will be compared to the efficacy and safety of the 5 mg tofacitinib immediate release tablets taken twice a day in patients with rheumatoid arthritis who continue taking methotrexate.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
209
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chiba, Japan, 260-8712
- National Hospital Organization Chiba-East Hospital
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Fukui, Japan, 910-0068
- Sugimoto rheumatology and internal medicine clinic
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Fukuoka, Japan, 810-8563
- National Hospital Organization Kyushu Medical Center
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Fukuoka, Japan, 814-0002
- SHONO Rheumatism Clinic
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Hokkaido, Japan, 060-0001
- Sagawa Akira Rheumatology Clinic
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Hyogo, Japan, 673-1462
- Matsubara Mayflower Hospital
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Kanagawa, Japan, 236-0037
- Yokohama Minami Kyosai Hospital
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Kumamoto, Japan, 862-0976
- Kumamoto Orthopaedic Hospital
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Kyoto, Japan, 605-0981
- Japanese Red Cross Kyoto Daiichi Hospital
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Oita, Japan, 870-0823
- Oribe Clinic of Rheumatology and Internal Medicine
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Oita, Japan, 870-1155
- Otsuka Clinic of Rheumatism and Medicine
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Saitama, Japan, 336-0911
- Rabbit Clinic
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Saitama, Japan, 359-1111
- Hirose Clinic
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Aichi
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Nagoya, Aichi, Japan, 453-8511
- Japanese Red Cross Nagoya Daiichi Hospital
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Nagoya, Aichi, Japan, 460-0001
- National Hospital Organization Nagoya Medical Center
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Toyohashi, Aichi, Japan, 440-8510
- National Hospital Organization Toyohashi Medical Center
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Ehime
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Matsuyama, Ehime, Japan, 790-0905
- Yamada Rheumatology Clinic
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Fukuoka
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Kurume, Fukuoka, Japan, 830-8543
- St. Mary's Hospital
-
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Gunma
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Takasaki-shi, Gunma, Japan, 370-0004
- Gunma Rheumatism Clinic
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Tohrimachi, Takasaki, Gunma, Japan, 370-0053
- Inoue Hospital
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Hiroshima
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Hiroshima-city, Hiroshima, Japan, 730-8619
- Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
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Hokkaido
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Asahikawa, Hokkaido, Japan, 070-8644
- National Hospital Organization Asahikawa Medical Center
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Asahikawa, Hokkaido, Japan, 078-8243
- Katayama Orthopaedic Rheumatology Clinic
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Iwate
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Morioka, Iwate, Japan, 020-0015
- Yoshida orthopaedics and rheumatologyclinic
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Morioka, Iwate, Japan, 020-0034
- Komagamine Rheumatoid Orthopaedic Clinic
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Kanagawa
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Sagamihara, Kanagawa, Japan, 252-0392
- National Hospital Organization Sagamihara National Hospital
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Yokohama, Kanagawa, Japan, 245-8575
- National Hospital Organization Yokohama Medical Center
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Miyagi
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Oosaki, Miyagi, Japan, 989-6183
- Osaki Citizen Hospital
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Sendai, Miyagi, Japan, 9808574
- Tohoku University Hospital/ Department of Hematology and Rheumatology
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Nagano
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Nagano-shi, Nagano, Japan, 380-8582
- Nagano Red Cross Hospital
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Nagasaki
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Sasebo, Nagasaki, Japan, 857-1195
- Sasebo Chuo Hospital
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Saga
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Ureshino-shi, Saga, Japan, 843-0393
- National Hospital Organization Ureshino Medical Center
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Tokyo
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Setagaya-ku, Tokyo, Japan, 157-0073
- Soshigayaokura clinic
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Shinagawa-ku, Tokyo, Japan, 142-8666
- Showa University Hospital
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Toyama
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Takaoka-shi, Toyama, Japan, 933-0874
- Honjo Rheumatism Clinic
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Yamaguchi
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Shunan, Yamaguchi, Japan, 745-0824
- Miyasato Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosis of rheumatoid arthritis
- currently taking a stable dose of methotrexate
- no evidence of active or latent or inadequately treated tuberculosis
Exclusion Criteria:
- evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease
- clinically significant infections within the past 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: tofacitinib modified release tablet
|
tofacitinib modified release 11 mg tablet administered once time a day for 12 weeks
tofacitinib immediate release 5 mg tablet administered twice a day for 12 weeks
|
Active Comparator: tofacitinib immediate release tablet
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tofacitinib modified release 11 mg tablet administered once time a day for 12 weeks
tofacitinib immediate release 5 mg tablet administered twice a day for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (C-Reactive Protein [CRP]) at Week 12
Time Frame: 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.
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Baseline, Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (Erythrocyte Sedimentation Rate [ESR]) at Week 12
Time Frame: Baseline, Week 12
|
DAS28 is a measure of disease activity in participants with rheumatoid arthritis.
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (millimeters per hour [mm/hr]) and patient global assessment of disease activity on a 100 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 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity.
DAS28-4 (ESR) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) <2.6 implied remission.
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Baseline, Week 12
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Number of Participants Achieving an American College of Rheumatology 20 Percent [%] (ACR20) Response at Week 12
Time Frame: Week 12
|
Participants with 20% improvement in 68-tender and 66-swollen joint counts and 20% improvement in at least 3 of the 5 measures: patient's global assessment of arthritis, physician global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire-disability index(HAQ-DI) and CRP.
Patient's global assessment of arthritis: participant assessed arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis.
Physician global assessment of arthritis: physician judged participants arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis.
Patient's assessment of arthritis pain: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (most severe pain), higher score implied more pain.
HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
|
Week 12
|
Number of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12
Time Frame: Week 12
|
Participants with 50% improvement in 68-tender and 66-swollen joint counts and 50% improvement in at least 3 of the 5 measures: patient's global assessment of arthritis, physician global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire-disability index(HAQ-DI) and CRP.
Patient's global assessment of arthritis: participant assessed arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis.
Physician global assessment of arthritis: physician judged participants arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis.
Patient's assessment of arthritis pain: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (most severe pain), higher score implied more pain.
HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
|
Week 12
|
Number of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Week 12
Time Frame: Week 12
|
Participants with 70% improvement in 68-tender and 66-swollen joint counts and 70% improvement in at least 3 of the 5 measures: patient's global assessment of arthritis, physician global assessment of arthritis, patient's assessment of arthritis pain, health assessment questionnaire-disability index(HAQ-DI) and CRP.
Patient's global assessment of arthritis: participant assessed arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis.
Physician global assessment of arthritis: physician judged participants arthritis by 100 mm VAS, score: 0 mm (no arthritis) to 100 mm (extreme arthritis), higher score implied more arthritis.
Patient's assessment of arthritis pain: participant assessed arthritis pain by 100 mm VAS, score: 0 mm (no pain) to 100 mm (most severe pain), higher score implied more pain.
HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score implied more disability.
|
Week 12
|
Number of Participants With DAS Remission (DAS28-4-CRP <2.6) at Week 12
Time Frame: Week 12
|
DAS28 is a measure of disease activity in participants with rheumatoid arthritis.
DAS28-4 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (mg/L) and patient global assessment of disease activity on a 100 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) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (CRP) <2.6 implied remission.
Number of participants with DAS remission (DAS28-4-CRP<2.6)
were reported in this outcome measure.
|
Week 12
|
Number of Participants With DAS Remission (DAS28-4-ESR <2.6) at Week 12
Time Frame: Week 12
|
DAS28 is a measure of disease activity in participants with rheumatoid arthritis.
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and patient global assessment of disease activity on a 100 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 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity.
DAS28-4 (ESR) <= 3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) <2.6 implied remission.
Number of participants with DAS remission (DAS28-4-ESR<2.6)
were reported in this outcome measure.
|
Week 12
|
Number of Participants With Low Disease Activity (DAS28-4-CRP <=3.2) at Week 12
Time Frame: Week 12
|
DAS28 is a measure of disease activity in participants with rheumatoid arthritis.
DAS28-4 (CRP) was calculated from SJC and TJC using 28 joints count, CRP (mg/L) and patient global assessment of disease activity on a 100 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) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (CRP) <2.6 implied remission.
Number of participants with low disease activity (DAS28-4-CRP<=3.2) were reported in this outcome measure.
|
Week 12
|
Number of Participants With Low Disease Activity (DAS28-4-ESR <=3.2) at Week 12
Time Frame: Week 12
|
DAS28 is a measure of disease activity in participants with rheumatoid arthritis.
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hr) and patient global assessment of disease activity on a 100 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 (ESR) score range: 0 (none) to 9.4 (extreme disease activity), higher score indicated more disease activity.
DAS28-4 (ESR) <=3.2 implied low disease activity and >3.2 to <=5.1 implied moderate disease activity, >5.1 implied high disease activity, and DAS28-4 (ESR) <2.6 implied remission.
Number of participants with low disease activity (DAS28-4-ESR<=3.2) were reported in this outcome measure.
|
Week 12
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12
Time Frame: Baseline, Week 12
|
HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 categories of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities over past week.
Each activity category consisted of 2-3 items.
Each item scored on 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 score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.
|
Baseline, Week 12
|
Number of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ Scores) at Week 12
Time Frame: Week 12
|
HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 categories of daily living activities: dressing/grooming; arising; eating; walking; reach; grip; hygiene; and other activities over past week.
Each activity category consisted of 2-3 items.
Each item scored on 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 score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.
Number of participants with an improvement of at least 0.22 units in HAQ scores from baseline to Week 12 were reported in this outcome measure.
|
Week 12
|
Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12
Time Frame: Baseline, Week 12
|
SF-36 is a participant reported standardized survey designed to assess generic health related quality of life.
It consisted of 36 items evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health.
The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition.
Scores of 8 health aspects were aggregated to derive the two component scores (physical component scores [PCS], mental component scores [MCS]) ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition.
|
Baseline, Week 12
|
Change From Baseline in the Short Form 36 (SF-36) Health Survey Component Scores at Week 12
Time Frame: Baseline, Week 12
|
SF-36 is a participant reported standardized survey designed to assess generic health related quality of life.
It consisted of 36 items evaluating 8 aspects of functional health and well-being: physical functioning, role physical, bodily pain, social functioning, mental health, role emotional, vitality, and general health.
The score range for each of the 8 health aspects was from 0 (poor health) to 100 (better health), higher scores indicating good health condition.
Scores of 8 health aspects were aggregated to derive the two component scores PCS and MCS ranging from 0 (worst) to 100 (best), where higher scores indicated good health condition.
|
Baseline, Week 12
|
Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Scores at Week 12
Time Frame: Baseline, Week 12
|
The FACIT-Fatigue Scale was a participant completed questionnaire consisted of 13 items that assessed fatigue.
Each item was scored on a scale of 0 (not at all) to 4 (very much), Total score ranging from 0 (not at all) to 52 (very much), higher scores represented lower level of fatigue.
|
Baseline, Week 12
|
Change From Baseline in the European Quality of Life - 5 Dimensions Questionnaire (EQ-5D) Scores at Week 12
Time Frame: Baseline, Week 12
|
EQ-5D was a participant completed instrument designed to assess impact on quality of life in terms of a single utility score in five domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression with 3 possible answers for each item (1=no problem, 2=moderate problems, 3=severe problems).
The 5-dimensional systems are converted into a single index utility score between 0 and 1, where higher score indicated a better health state.
|
Baseline, Week 12
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to 12 weeks
|
An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
An 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 AEs were events between first dose of study drug and up to 12 weeks that were absent before treatment or that worsened relative to pretreatment state.
AEs included both serious and non- serious adverse events.
|
Baseline up to 12 weeks
|
Number of Participants With Clinically Significant Laboratory Test Abnormalities
Time Frame: Baseline up to 12 weeks
|
Criteria: lipids(cholesterol[CH] milligrams/deciliter[mg/dL] >1.3*upper limit normal(ULN), high-density lipoprotein CH mg/dL <0.8*lower limit normal(LLN), Low-density lipoprotein CH mg/dL >1.2* ULN, triglycerides mg/dL >1.3*ULN); neutrophil count(NC) <1000 cells/cubic milliliters(mm^3), platelet counts(PC) <100,000 P/mm^3, lymphocyte counts(LC) <500 L/mm^3, any single (aspartate transaminase elevation(ASTE)/alanine transaminase elevation(ALTE) >=3*ULN, hemoglobin(Hb) value <8.0 grams(g)/dL or >=2 g/dL below baseline, any serum creatinine(SC) increase(inc) >50% or inc >0.5 mg/dL over the average of screening(OAS) and baseline values(BV), 2 sequential ASTE/ALTE>=3*ULN with total bilirubin value(TBV) >=2*ULN, ASTE/ALTE >=3*ULN, ASTE/ALTE >=5*ULN, Hb <8.0 g/dL or decrease of >30% from BV, PC <75,000 P/mm^3, NC <1000 cells/mm^3, LC <500 L/mm^3, confirmed inc in SC >50% OAS and BV and detection of hepatitis B virus-deoxyribonucleic acid(HBV-DNA) by the two sequential quantitative tests.
|
Baseline up to 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 18, 2014
Primary Completion (Actual)
March 15, 2017
Study Completion (Actual)
March 15, 2017
Study Registration Dates
First Submitted
October 30, 2014
First Submitted That Met QC Criteria
October 30, 2014
First Posted (Estimate)
November 2, 2014
Study Record Updates
Last Update Posted (Actual)
October 12, 2018
Last Update Submitted That Met QC Criteria
March 12, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A3921215
- TOFACITINIB QD P3 (Other Identifier: Alias Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:
http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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