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

Sponsor

Centocor, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00236028

Collaborator

(none)

607

Enrollment

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Infliximab	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

607 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) in Combination With Methotrexate Compared With Methotrexate Alone for the Treatment of Patients With Early Rheumatoid Arthritis

Actual Study Completion Date :

Apr 1, 2003

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Safety assessments throughout the study. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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