This study will evaluate the safety \& efficacy of Certolizumab Pegol (CZP) as additional medication to Methotrexate (MTX) in Chinese subjects with Rheumatoid Arthritis. 400 patients will be randomized to receive either CZP + MTX or placebo + MTX. Anticipated time in the study is about 32 weeks.
This is a phase 3, multicenter, double-blind, placebo-controlled, parallel group, randomized, 24-week study to evaluate the safety and efficacy of Certolizumab Pegol (CZP) as additional medication to Methotrexate (MTX) in Chinese subjects with active Rheumatoid Arthritis (RA) who have an incomplete response to Methotrexate. This study is designed to determine whether CZP 400 mg at Weeks 0, 2, and 4 followed by CZP 200 mg every 2 weeks (Q2W) in combination with MTX demonstrates superiority, in terms of greater improvement in relief of the signs and symptoms of RA, compared with MTX alone. Approximately 535 subjects will be screened to randomize 400 subjects into this study, at approximately 25 centers in the People's Republic of China. There will be 2 treatment groups, with 300 subjects in the CZP+MTX group and 100 subjects in the PBO+MTX group. For each subject, the study duration will last a maximum of approximately 38 weeks. Subjects who complete study RA0044 and subjects who fail to achieve an American College of Rheumatology 20 % Response Criteria (ACR20) response at Week 12 that is confirmed at Week 14 and thus are withdrawn from this study at Week 16, are permitted to receive treatment with CZP in the open-label extension study, RA0078. The secondary objectives are to assess the dose regimen of CZP in combination with MTX compared with MTX alone in the safety and tolerability, ability to improve physical function, and health outcomes measures in Chinese subjects with active RA; also to characterize the pharmacokinetic (PK) profile and immunogenicity of CZP in combination with MTX.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
430
* Active substance: Certolizumab Pegol * Pharmaceutical Form: Prefilled syringes * Concentration: 200 mg/ml * Route of administration: Subcutaneous injection
* Active substance: Methotrexate * Pharmaceutical form: Tablet * Concentration: Maximum dose 10 mg per week * Route of administration: Oral
* Active substance: Placebo * Pharmaceutical form: Prefilled syringes * Concentration: 0.9 % saline * Route of Administration: Subcutaneous injection
037
Baotou, China
001
Beijing, China
Percentage of Subjects Meeting the American College of Rheumatology 20 % Response Criteria (ACR20) at Week 24
The assessments are based on a 20 % or greater improvement from Baseline to Week 24 in the number of tender joints, in the number of swollen joints, and a 20 % or greater improvement in at least 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Time frame: Week 24
Percentage of Subjects Meeting the American College of Rheumatology 50 % Response Criteria (ACR50) at Week 24
The assessments are based on a 50 % or greater improvement from Baseline to Week 24 in the number of tender joints, in the number of swollen joints, and a 50 % or greater improvement in at least 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Time frame: Week 24
Percentage of Subjects Meeting the American College of Rheumatology 70 % Response Criteria (ACR70) at Week 24
The assessments are based on a 70 % or greater improvement from Baseline to Week 24 in the number of tender joints, in the number of swollen joints, and a 70 % or greater improvement in at least 3 of the 5 remaining core set measures: Patient's Global Assessment of Disease Activity (PtGADA), Physician's Global Assessment of Disease Activity (PhGADA), Patient's Assessment of Arthritis Pain (PtAAP), physical function as assessed by the Health Assessment Questionnaire - Disability Index (HAQ-DI) and C-Reactive Protein (CRP).
Time frame: Week 24
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24
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002
Beijing, China
013
Beijing, China
021
Beijing, China
025
Beijing, China
033
Beijing, China
014
Bengbu, China
011
Changchun, China
034
Changchun, China
...and 20 more locations
The HAQ-DI assesses the degree of difficulty experienced in 8 domains of daily living activities using 20 questions. Each domain consists of 2 or 3 items. For each question, the level of difficulty is scored from 0 to 3. A total score is computed from the item scores using the scoring rules provided by the index's author. HAQ-DI scores range from 0 to 3. Lower scores indicate less disability. Negative values indicate improvement from Baseline.
Time frame: Baseline, Week 24