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

Phase 3

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00236028
• Lead Sponsor: Centocor, Inc.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Completion: 2003-04
• Study First Submitted: 2005-10-07
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-12
• Status Verified: 2010-03
• Last Update Submitted: 2011-05-18
• Last Update Posted: 2011-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 607

Inclusion Criteria

• Diagnosis of rheumatoid arthritis for at least 3 months and less than or equal to 3 years before screening
• Active disease at the time of screening and pre-infusion of the drug

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 little or no ability for self care
• Rheumatic disease other than rheumatoid arthritis or any current systemic inflammatory condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement from baseline in clinical signs and symptoms, prevention of structural damage, and prevention of physical disability evaluated at week 54.

Secondary Outcome Measures

Name	Time	Method
Safety assessments throughout the study.