A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)
- Sponsor
- Hoffmann-La Roche
- Study ID
- NCT00422383
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- rituximab [MabThera/Rituxan] — DRUG500mg iv in days 1 and 15, and 500mg iv on days 168 and 182
- rituximab [MabThera/Rituxan] — DRUG500mg iv on days 1 and 15, and 1000mg iv on days 168 and 182
- rituximab [MabThera/Rituxan] — DRUG1000mg iv on days 1 and 15 and 1000mg iv (or placebo in UK)on days 168 and 182
Study Details
This study will evaluate the efficacy and safety of various treatment and retreatment regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly either orally or parenterally. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.
Key Dates
- Start date
- Feb 28, 2006
- Status verified
- Apr 2015
- Primary completion
- Mar 31, 2013
- Completion
- Mar 31, 2013
Study Design
- Enrollment
- 378 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 1
- Experimental: 2
- Experimental: 3
Primary Outcome Measure
Percentage of Participants With a Response as Determined by American College of Rheumatology (ACR) 20% Improvement (ACR20) [ Time Frame: Week 48 ]
Related Studies
- CorEvitas Rheumatoid Arthritis (RA) Drug Safety & Effectiveness RegistryEnrolling By Invitation · CorEvitas · Waltham, Massachusetts
- Physica System Total Knee Replacement Registry StudyRecruiting · Limacorporate S.p.a · Rancho Mirage, California
- Early Rheumatoid Arthritis Lung Disease StudyRecruiting · University of Nebraska · Omaha, Nebraska
- Maternal Autoimmune Disease Research Alliance (MADRA) RegistryRecruiting · Duke University · Durham, North Carolina