Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis - Full Text View

Sponsored by:	Centocor, Inc.
Information provided by:	Centocor, Inc.
ClinicalTrials.gov Identifier:	NCT00269867

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Infliximab	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Immunoglobulins Globulin, Immune Infliximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

safety

Estimated Enrollment:

428

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269867

Sponsors and Collaborators

Centocor, Inc.

Investigators

Study Director:

Centocor, Inc. Clinical Trial

Centocor, Inc.

More Information

Publications of Results:

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.

Study ID Numbers:	CR006259
Study First Received:	December 22, 2005
Last Updated:	April 6, 2007
ClinicalTrials.gov Identifier:	NCT00269867
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centocor, Inc.:

Rheumatoid Arthritis
infliximab
methotrexate

Study placed in the following topic categories:

Autoimmune Diseases
Infliximab
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Antibodies, Monoclonal
Folic Acid

Antibodies
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Methotrexate
Immunoglobulins

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Enzyme Inhibitors

Reproductive Control Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 15, 2009