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
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Centocor, Inc. |
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
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 |
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