Conditions: Rheumatoid Arthritis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 302
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous inadequate response to a)etanercept, b)infliximab or c)adalimumab. Patients will be treated with MabThera (1g infusion) on day 1 and day 15, and will continue their basic methotrexate therapy. The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: rituximab [MabThera]
Intervention descriptions: intervention 1: 1 g was given by intravenous infusion on Days 1 and 15

Protocol document: