Phase 2
Completed N=465
Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov NCT02093026 ↗Enrolled (actual)
465
Serious AEs
40.9%
Results posted
Mar 2017
Primary outcomePrimary: Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response After First Course — 67.1 percentage of participants
Summary
This study will assess the long-term safety and efficacy of repeat treatment courses of rituximab, in combination with methotrexate in a disease-modifying anti-rheumatic drug (DMARD) inadequate responder population of participants who were previously randomized into studies WA16291 (NCT02693210) or WA17043/U2644g (NCT00074438). The study permits multiple re-treatments until the protocol-defined end-of-treatment date (31 December 2011). Participants will then enter a safety follow-up (SFU) period of at least 48 weeks. This will provide at least 7 years follow-up data on all participants initially randomized into WA16291 or WA17043/U2644g. Approximately 600 participants will potentially be eligible to enter this open label extension study from their respective feeder studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an American College of Rheumatology 20 (ACR20) Response After First Course |
67.1 | — |
| PRIMARY Percentage of Participants With ACR20 Response After Second Course |
70.8 | — |
| PRIMARY Percentage of Participants With ACR20 Response After Third Course |
73.2 | — |
| PRIMARY Percentage of Participants With ACR20 Response After Fourth Course |
75.1 | — |
| PRIMARY Percentage of Participants With ACR20 Response After Fifth Course |
69.7 | — |
| PRIMARY Percentage of Participants With ACR20 Response After Sixth Course |
68.2 | — |
| PRIMARY Percentage of Participants With ACR20 Response After Seventh Course |
59.5 | — |
| SECONDARY Percentage of Participants With ACR50 and ACR70 Response |
39.4; 41.9; 44.8; 46.9; 40.0; 40.0 | — |
| SECONDARY American College of Rheumatology Index of Improvement (ACRn) Response |
31.07; 34.15; 36.93; 39.59; 33.76; 29.74 | — |
| SECONDARY Percentage of Participants With Low Disease Activity and Clinical Remission Based on DAS28-ESR |
24.3; 30.1; 29.3; 28.0; 23.8; 27.3 | — |
| SECONDARY Percentage of Participants With European League Against Rheumatism (EULAR) Response of 'Good' or 'Moderate' |
57.8; 58.5; 59.5; 60.9; 62.1; 57.0 | — |
| SECONDARY Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at 24 Weeks Following Each Course |
-0.51; -0.48; -0.43; -0.47; -0.44; -0.38 | — |
| SECONDARY Change From Baseline in Total Rheumatoid Factors (RF) at 24 Weeks Following Each Course |
— | — |
| SECONDARY Percentage of Participants Who Discontinued Treatment Due to Insufficient Response |
1.1; 2.3; 2.0; 2.0; 0.8; 0.0 | — |
| SECONDARY Time Since Last Treatment Course |
4.21 | — |
Eligibility Criteria
Inclusion Criteria
- participants with active RA
- completed 24 weeks of treatment in WA16291 or WA17043
- eligible for re-treatment, based on clinical symptoms (Disease Activity Score in 28 joints >=2.6)
- females of childbearing potential using reliable contraception
Exclusion Criteria
- participants who participated in rituximab studies WA16291 or WA17043 but withdrew into the safety follow-up phases of these trials
- previous rituximab non-responders
- current treatment with any other disease-modifying drug (apart from methotrexate), or any anti-tumor necrosis factor alfa, anti-interleukin-1, or other biologic therapies
- participants with known active infection of any kind
- evidence of any new or uncontrolled concomitant disease or development of any new contraindications which would preclude repeat treatment with rituximab
- history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- female participants who are pregnant or breastfeeding
Data sourced from ClinicalTrials.gov (NCT02093026). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.