NCT00299130View on ClinicalTrials.gov

A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis

PHASE3CompletedINTERVENTIONAL
Enrollment

511

Participants

Timeline

Start Date

October 31, 2005

Primary Completion Date

June 30, 2008

Study Completion Date

July 31, 2013

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Folate

A stable dose, ≥ 5 mg/week given as either a single dose or as a divided weekly dose, orally.

DRUG

Methotrexate

A stable dose of between 10-25 mg/week, oral or parenteral, as prescribed by the treating physician.

DRUG

Methylprednisolone

Intravenous infusion

DRUG

Placebo

Placebo to rituximab intravenous infusion

DRUG

Rituximab

Intravenous infusion

Sponsors

Lead Sponsor

Genentech, Inc.
All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

Genentech, Inc.

INDUSTRY