A Study of the Safety and Efficacy of Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Methotrexate

PHASE2CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

August 31, 2005

Primary Completion Date

February 28, 2009

Study Completion Date

February 28, 2009

Conditions
Rheumatoid Arthritis
Interventions
DRUG

folate

Minimum of 1 mg/day oral (or folinic acid 5 mg/week)

DRUG

methotrexate

15-25 mg/week oral or parenteral (10-14 mg/week if intolerant)

DRUG

methylprednisolone

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)

DRUG

Placebo

To maintain the blind, patients in Arm B (Rituximab 1000 mg) received placebo infusions at Months 6 and 18.

DRUG

Rituximab

500 mg or 1000 mg IV\*2.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY