Conditions: Rheumatoid Arthritis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 246
Healthy volunteers: no

Brief summary:
This single arm study will assess the safety of MabThera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents. Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate \>=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms:
arm 1: Eligible participants receiving Rituximab (MabThera/Rituxan) 1 gram/dose (g/dose) intravenously (IV) on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg per oris (PO) weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.

Interventions: intervention 1: Methotrexate intervention 2: rituximab [MabThera/Rituxan]
Intervention descriptions: intervention 1: \>=15 mg po/week intervention 2: 1g iv on days 1 and 15

Protocol document: