Clinical trial NCT00269867: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
infliximab
methotrexate
Lead sponsor: Centocor, Inc.
Sponsor class: INDUSTRY
First posted: 2005-12-26
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

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

Primary outcomes:
measure: Change from baseline in ACR20 response at week 30; Change in modified van der Heijde-Sharp Score
timeFrame: Baseline and Week 30
Secondary outcomes:
measure: safety
timeFrame: up to Week 54
Other outcomes:
Locations:
Study officials:
affiliation: Centocor, Inc.
name: Centocor, Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1056/NEJM200011303432202.
citation: Mack ME, Hsia E, Aletaha D. Comparative Assessment of the Different American College of Rheumatology/European League Against Rheumatism Remission Definitions for Rheumatoid Arthritis for Their Use as Clinical Trial End Points. Arthritis Rheumatol. 2017 Mar;69(3):518-528. doi: 10.1002/art.39945.