Conditions: Rheumatoid Arthritis
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 36
Healthy volunteers: no

Brief summary:
This single arm study will assess the safety and efficacy of MabThera in combination with methotrexate in patients with rheumatoid arthritis who have had an inadequate response or intolerance to one or more anti-TNF agents. Patients will receive MabThera 1000mg i.v. on days 1 and 15, and methotrexate (10-25mg/week p.o. or parenteral), together with methylprednisolone 100mg i.v. prior to infusion of MabThera. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: rituximab [MabThera/Rituxan] intervention 2: Methotrexate
Intervention descriptions: intervention 1: 1000mg iv on days 1 and 15 intervention 2: 10-25mg/week po or parenteral

Protocol document: