Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, infliximab, methotrexate
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.
Interventions
DRUGPlacebo
Matching placebo will be adminstered at Week 0, 2, 6 and every 4 weeks up to Week 54.
DRUGInfliximab 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 (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.
Sponsors
Centocor, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in ACR20 response at week 30; Change in modified van der Heijde-Sharp Score | Baseline and Week 30 |
Secondary
| Measure | Time frame |
|---|---|
| safety | up to Week 54 |
Outcome results
None listed