Infliximab Plus Methotrexate for the Treatment of Rheumatoid Arthritis

Centocor Ortho Biotech

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Infliximab 10 mg/kg; Drug: Infliximab 3 mg/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00269867

CR006259

Details and patient eligibility

About

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.

Full 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.

Enrollment: 428 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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428 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.

Treatment:

Drug: Placebo

Infliximab 3 mg/kg every 8 weeks

Experimental group

Description:

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.

Treatment:

Drug: Infliximab 3 mg/kg

Infliximab 3 mg/kg every 4 weeks

Experimental group

Description:

Infliximab 3 mg/kg will be administered as infusion at Week 0, 2, 6 and every 4 weeks up to Week 52.

Treatment:

Drug: Infliximab 3 mg/kg

Infliximab 10 mg/kg every 8 weeks

Experimental group

Description:

Infliximab 10 mg/kg will be administered as infusion at Week 0, 2, 6 and every 8 weeks up to Week 52.

Treatment:

Drug: Infliximab 10 mg/kg

Infliximab 10 mg/kg every 4 weeks

Experimental group

Description:

Infliximab 3 mg/kg will be administered as infusion at Week 0, 2, 6 and every 4 weeks up to Week 52.

Treatment:

Drug: Infliximab 10 mg/kg