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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
1000mg iv on days 1 and 15
10-25mg weekly
Unnamed facility
Casablanca, Morocco
Unnamed facility
Casablanca, Morocco
Unnamed facility
Marrakesh, Morocco
Unnamed facility
Rabat, Morocco
Unnamed facility
Salé, Morocco
Percentage of Participants With an Adverse Event (AE)
Time frame: Week 104
Disease Activity Score Based on 28-Joint Count (DAS28)
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.
Time frame: Day 1 and Week 24
Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category
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.
Time frame: Screening, Day 1, and Weeks 24 and 104
Percentage of Participants With Changes in Bone Density
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.
Time frame: Screening, Weeks 48 and 104
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