Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 22, 2005

Last Updated Date

April 6, 2007

Start Date ^†

Current Primary Outcome Measures ^†

Change from baseline in ACR20 response at week 30; Change in modified van der Heijde-Sharp Score

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00269867 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

safety

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis

Official Title ^†

A Placebo-Controlled, Double-Blinded, Randomized Clinical Trial of Anti-TNF Chimeric Monoclonal Antibody (cA2) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Treatment

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of infliximab (an anti-TNF chimeric monoclonal antibody [cA2]) in patients with active Rheumatoid Arthritis, despite methotrexate treatment.

Detailed Description

This is a placebo-controlled, double-blinded, randomized clinical study to evaluate the safety and effectiveness of infliximab in patients with active Rheumatoid Arthritis, despite methotrexate treatment. Infliximab is an anti-TNF chimeric monoclonal antibody (cA2). The primary measures of effectiveness include the change from baseline in American College of Rheumatology (ACR20) response at week 30, and the change in the modified van der Heijde Sharp Score. The ACR20 Responder Index a composite of clinical, laboratory, and functional measures and the van der Heijde-Sharp (vdH-S) scoring method is a method of rating structural damage in patients..

Patients will be treated with either infliximab or matching placebo.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Rheumatoid Arthritis

Intervention ^†

Drug: Infliximab

Study Arms / Comparison Groups

Publications *

Lipsky PE, van der Heijde DM, St Clair EW, Furst DE, Breedveld FC, Kalden JR, Smolen JS, Weisman M, Emery P, Feldmann M, Harriman GR, Maini RN; Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. Infliximab and methotrexate in the treatment of rheumatoid arthritis. Anti-Tumor Necrosis Factor Trial in Rheumatoid Arthritis with Concomitant Therapy Study Group. N Engl J Med. 2000 Nov 30;343(22):1594-602.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

428

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Patients with active Rheumatoid Arthritis despite treatment with methotrexate
Diagnosed with Rheumatoid Arthritis at least 6 months prior to screening
Having active disease at the time of screening and pre-infusion as defined by having at least 6 or more swollen joints and 6 or more tender joints
Using methotrexate for at least 3 months prior to study enrollment

Exclusion Criteria:

Patients having any systemic inflammatory condition
Having Lyme disease or a rheumatic disease other than Rheumatoid Arthritis
Who have used Disease-Modifying Antirheumatic Drugs (DMARDs) other than methotrexate within 4 weeks prior to screening
Who have used corticosteroids within 4 weeks prior to screening
Having received previous administration of infliximab

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00269867

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Centocor, Inc.

Collaborators ^††

Investigators ^†

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

Information Provided By

Centocor, Inc.

Verification Date

April 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.