A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid Arthritis

Last updated: May 18, 2011
Sponsor: Centocor, Inc.
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Joint Injuries

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT00236028
CR003118
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of infliximab (Remicade) in patients with early rheumatoid arthritis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis for at least 3 months and less than or equal to 3years before screening

  • Active disease at the time of screening and pre-infusion of the drug

Exclusion

Exclusion Criteria:

  • Pregnant, nursing, or planning a pregnancy within 18 months of enrollment

  • Incapacitated, largely or wholly bedridden, or confined to a wheelchair, or had littleor no ability for self care

  • Rheumatic disease other than rheumatoid arthritis or any current systemic inflammatorycondition

Study Design

Total Participants: 607
Study Start date:
Estimated Completion Date:
April 30, 2003

Study Description

This is a randomized, multicenter, double-blind, active-treatment-controlled, three-arm, parallel study of chronic treatment with infliximab. This study will determine whether infliximab, at two different doses (3 mg/kg or 6 mg/kg) in combination with methotrexate (MTX), reduces the signs and symptoms (such as joint pain, swelling and stiffness) of rheumatoid arthritis. The study will also compare their effect on slowing down the joint damage associated with rheumatoid arthritis. Additional information on the safety of infliximab treatment will be obtained. The study will last for about 1 year. Patients will receive methotrexate and total of eight intravenous infusions of the study medication (Infliximab or placebo) spaced out over the first year. After the final infusion of study medication, several follow-up visits are to be made. Patients will receive methotrexate (start at 7.5mg/wk, increased to 20mg/wk by week8) and intravenous infusions of the study medication (Infliximab 3 or 6mg/kg, or placebo) at week 0, 2, and 6, and every 8 weeks thereafter through week 46.