Conditions: Rheumatoid Arthritis
Keywords: Rituxan RA
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 42
Healthy volunteers: no

Brief summary:
This was a Phase II, randomized, double-blind, multicenter study designed to evaluate the safety and efficacy of rituximab, administered at two different regimens for 2 years, in patients with moderate to severe active rheumatoid arthritis (RA) receiving stable doses of methotrexate (MTX).

Detailed description:

Arms:
arm 1: Rituximab: 1000 mg intravenous (IV) on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18).

Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion.

Methotrexate: 15-25 mg/wk oral or parenteral (10-14 mg/wk if intolerant).

Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk). arm 2: Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12.) For the Month 6 and 18 cycles, rituximab or placebo was administered.

Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion.

Methotrexate: 15-25 mg/wk oral or parenteral (10-14 mg/wk if intolerant).

Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).

Interventions: intervention 1: folate intervention 2: methotrexate intervention 3: methylprednisolone intervention 4: Placebo intervention 5: Rituximab
Intervention descriptions: intervention 1: Minimum of 1 mg/day oral (or folinic acid 5 mg/week) intervention 2: 15-25 mg/week oral or parenteral (10-14 mg/week if intolerant) intervention 3: 100 mg intravenous (IV) prior to each rituximab infusion (For Arm B, for the Months 6 and 18 cycles, IV saline was administered prior to each placebo infusion) intervention 4: To maintain the blind, patients in Arm B (Rituximab 1000 mg) received placebo infusions at Months 6 and 18. intervention 5: 500 mg or 1000 mg IV\*2.

Protocol document: