Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Infliximab 3 mg/kg; Drug: Infliximab 10 mg/kg; Drug: Placebo

• Registration Number: NCT00269867
• Lead Sponsor: Centocor, Inc.

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 Timeline

• Study Start: 1997-03
• Primary Completion: 2000-03
• Study Completion: 2000-03
• Study First Submitted: 2005-12-22
• Study First Submitted QC: 2005-12-22
• Study First Posted: 2005-12-26
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-03
• Last Update Posted: 2014-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 428

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infliximab 3 mg/kg every 8 weeks	Infliximab 3 mg/kg	Infliximab 3 milligram per kilogram (mg/kg) will be administered as infusion at Week 0, 2, 6 and every 8 weeks up to Week 52.
Infliximab 10 mg/kg every 8 weeks	Infliximab 10 mg/kg	Infliximab 10 mg/kg will be administered as infusion at Week 0, 2, 6 and every 8 weeks up to Week 52.
Placebo	Placebo	Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.
Infliximab 3 mg/kg every 4 weeks	Infliximab 3 mg/kg	Infliximab 3 mg/kg will be administered as infusion at Week 0, 2, 6 and every 4 weeks up to Week 52.
Infliximab 10 mg/kg every 4 weeks	Infliximab 10 mg/kg	Infliximab 3 mg/kg will be administered as infusion at Week 0, 2, 6 and every 4 weeks up to Week 52.

Primary Outcome Measures

Name	Time	Method
Change from baseline in ACR20 response at week 30; Change in modified van der Heijde-Sharp Score	Baseline and Week 30

Secondary Outcome Measures

Name	Time	Method
safety	up to Week 54