Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis

PHASE3CompletedINTERVENTIONAL
Enrollment

428

Participants

Timeline

Start Date

March 31, 1997

Primary Completion Date

March 31, 2000

Study Completion Date

March 31, 2000

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Placebo

Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.

DRUG

Infliximab 3 mg/kg

Infliximab (anti-TNF chimeric monoclonal antibody \[cA2\]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.

DRUG

Infliximab 10 mg/kg

Infliximab (anti-TNF chimeric monoclonal antibody \[cA2\]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Centocor, Inc.

INDUSTRY