A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate
This study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who have had an inadequate response or were intolerant to treatment with methotrexate. Eligible patients will receive MabThera (1000mg by intravenous infusion) on days 1 and 15, and background methotrexate (oral or subcutaneous dose of 10-25mg weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.
Drug: rituximab [MabThera/Rituxan]
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate|
- Percentage of Participants With an Adverse Event (AE) [ Time Frame: Week 104 ] [ Designated as safety issue: No ]
- Disease Activity Score Based on 28-Joint Count (DAS28) [ Time Frame: Day 1 and Week 24 ] [ Designated as safety issue: No ]DAS28 was calculated from the number of swollen joints and tender joints using the 28 joint count; the erythrocyte sedimentation rate (ESR) measured in millimeters per hour [mm/hr]); and the Patient's Global Assessment of disease activity (participant-rated visual analog assessment [VAS]) with transformed scores with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Overall, a DAS28 score of less than or equal to (≤) 3.2 equals (=) low disease activity, and a DAS28 score of greater than (>) 3.2 to 5.1 = moderate to high disease activity.
- Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category [ Time Frame: Screening, Day 1, and Weeks 24 and 104 ] [ Designated as safety issue: No ]DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline greater than (>)1.2 with DAS28 less than or equal to (≤)3.2; moderate responders: change from baseline >1.2 with DAS28 >3.2 to ≤5.1 or change from baseline >0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6 or change from baseline >0.6 and ≤1.2 with DAS28 >5.1.
- Percentage of Participants With Changes in Bone Density [ Time Frame: Screening, Weeks 48 and 104 ] [ Designated as safety issue: No ]Change in bone density in participants untreated with bisphosphonates was classified as percentage of participants with osteoporosis, osteopenia, or normal. In some participants, no determinations were available.
|Study Start Date:||October 2007|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Drug: rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15Drug: methotrexate
Please refer to this study by its ClinicalTrials.gov identifier: NCT00934648
|Casablanca, Morocco, 20000|
|Casablanca, Morocco, 20100|
|Marrakech, Morocco, 40000|
|Rabat, Morocco, 10150|
|Salé, Morocco, 15045|
|Study Director:||Clinical Trials||Hoffmann-La Roche|