Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269867
• Other study ID #: CR006259
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2005
• Last updated: November 3, 2014
• Start date: March 1997
• Est. completion date: March 2000

Study information

• Verified date: November 2014
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: March 2000
• Est. primary completion date: March 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Placebo
Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.
• Infliximab 3 mg/kg
Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.
• Infliximab 10 mg/kg
Infliximab (anti-TNF chimeric monoclonal antibody [cA2]) 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks or every 4 weeks up to Week 52.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

References & Publications (1)

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 m — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in ACR20 response at week 30; Change in modified van der Heijde-Sharp Score		Baseline and Week 30	No
Secondary	safety		up to Week 54	Yes