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
- Registration Number
- NCT02281552
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 209
- diagnosis of rheumatoid arthritis
- currently taking a stable dose of methotrexate
- no evidence of active or latent or inadequately treated tuberculosis
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tofacitinib modified release tablet Tofacitinib - tofacitinib immediate release tablet Tofacitinib -
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Number of Participants Achieving an American College of Rheumatology 50% (ACR50) Response at Week 12 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.
Change From Baseline in Disease Activity Score in 28 Joints Using 4 Variables (DAS28-4) (Erythrocyte Sedimentation Rate [ESR]) at Week 12 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.
Number of Participants Achieving an American College of Rheumatology 20 Percent [%] (ACR20) Response at Week 12 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.
Change From Baseline in the Short Form 36 (SF-36) Health Survey Component Scores at Week 12 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.
Number of Participants Achieving an American College of Rheumatology 70% (ACR70) Response at Week 12 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.
Number of Participants With DAS Remission (DAS28-4-CRP <2.6) at Week 12 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.
Number of Participants With Low Disease Activity (DAS28-4-CRP <=3.2) at Week 12 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.
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 12 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.
Number of Participants Achieving an Improvement of at Least 0.22 Units in Health Assessment Questionnaire (HAQ Scores) at Week 12 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.
Change From Baseline in the Short Form 36 (SF-36) Health Survey Domain Scores at Week 12 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.
Number of Participants With DAS Remission (DAS28-4-ESR <2.6) at Week 12 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.
Number of Participants With Low Disease Activity (DAS28-4-ESR <=3.2) at Week 12 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.
Change From Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Scores at Week 12 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.
Change From Baseline in the European Quality of Life - 5 Dimensions Questionnaire (EQ-5D) Scores at Week 12 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.
Trial Locations
- Locations (36)
National Hospital Organization Toyohashi Medical Center
🇯🇵Toyohashi, Aichi, Japan
Yamada Rheumatology Clinic
🇯🇵Matsuyama, Ehime, Japan
Inoue Hospital
🇯🇵Tohrimachi, Takasaki, Gunma, Japan
Yoshida orthopaedics and rheumatologyclinic
🇯🇵Morioka, Iwate, Japan
Showa University Hospital
🇯🇵Shinagawa-ku, Tokyo, Japan
Sugimoto rheumatology and internal medicine clinic
🇯🇵Fukui, Japan
SHONO Rheumatism Clinic
🇯🇵Fukuoka, Japan
Sagawa Akira Rheumatology Clinic
🇯🇵Hokkaido, Japan
Matsubara Mayflower Hospital
🇯🇵Hyogo, Japan
Yokohama Minami Kyosai Hospital
🇯🇵Kanagawa, Japan
Kumamoto Orthopaedic Hospital
🇯🇵Kumamoto, Japan
Hirose Clinic
🇯🇵Saitama, Japan
National Hospital Organization Sagamihara National Hospital
🇯🇵Sagamihara, Kanagawa, Japan
Rabbit Clinic
🇯🇵Saitama, Japan
Osaki Citizen Hospital
🇯🇵Oosaki, Miyagi, Japan
Soshigayaokura clinic
🇯🇵Setagaya-ku, Tokyo, Japan
National Hospital Organization Yokohama Medical Center
🇯🇵Yokohama, Kanagawa, Japan
Sasebo Chuo Hospital
🇯🇵Sasebo, Nagasaki, Japan
Otsuka Clinic of Rheumatism and Medicine
🇯🇵Oita, Japan
St. Mary's Hospital
🇯🇵Kurume, Fukuoka, Japan
Japanese Red Cross Nagoya Daiichi Hospital
🇯🇵Nagoya, Aichi, Japan
National Hospital Organization Asahikawa Medical Center
🇯🇵Asahikawa, Hokkaido, Japan
Katayama Orthopaedic Rheumatology Clinic
🇯🇵Asahikawa, Hokkaido, Japan
Tohoku University Hospital/ Department of Hematology and Rheumatology
🇯🇵Sendai, Miyagi, Japan
Nagano Red Cross Hospital
🇯🇵Nagano-shi, Nagano, Japan
National Hospital Organization Nagoya Medical Center
🇯🇵Nagoya, Aichi, Japan
Gunma Rheumatism Clinic
🇯🇵Takasaki-shi, Gunma, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
🇯🇵Hiroshima-city, Hiroshima, Japan
Komagamine Rheumatoid Orthopaedic Clinic
🇯🇵Morioka, Iwate, Japan
National Hospital Organization Chiba-East Hospital
🇯🇵Chiba, Japan
National Hospital Organization Ureshino Medical Center
🇯🇵Ureshino-shi, Saga, Japan
Honjo Rheumatism Clinic
🇯🇵Takaoka-shi, Toyama, Japan
Miyasato Clinic
🇯🇵Shunan, Yamaguchi, Japan
National Hospital Organization Kyushu Medical Center
🇯🇵Fukuoka, Japan
Japanese Red Cross Kyoto Daiichi Hospital
🇯🇵Kyoto, Japan
Oribe Clinic of Rheumatology and Internal Medicine
🇯🇵Oita, Japan