Conditions: Rheumatoid Arthritis
Keywords: RA Arthritis
Allocation: NA | Intervention model: PARALLEL
Enrollment: 28
Healthy volunteers: no

Brief summary:
This is a Phase II, randomized, active-controlled, double-blind, double-dummy, parallel-group, multicenter study in the United States enrolling patients with active RA. The study will enroll approximately 290 patients at approximately 130 sites.

Detailed description:

Arms:
arm 1: Participants received two intravenous (IV) infusions of 200 mg ocrelizumab administered on Day 1 and Day 15 and placebo IV infliximab infusions administered on Day 1, Day 15, Week 6, and Week 14. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity. arm 2: Participants received four IV infusions of 5 mg/kg infliximab administered on Day 1, Day 15, Week 6, and Week 14 and placebo ocrelizumab infusions administered on Day 1 and Day 15. In addition to the study medication, all patients were to receive methotrexate at a stable dose of 7.5-25 mg/week and folic acid or equivalent at a dose of 5 mg/week to minimize methotrexate toxicity.

Interventions: intervention 1: Infliximab intervention 2: Methotrexate intervention 3: Methylprednisolone intervention 4: Ocrelizumab intervention 5: Placebo
Intervention descriptions: intervention 1: Intravenous repeating dose intervention 2: Oral or parenteral repeating dose intervention 3: Intravenous repeating dose intervention 4: Intravenous repeating dose intervention 5: Intravenous repeating dose

Protocol document: