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Sponsored by: |
Centocor, Inc. |
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Information provided by: | Centocor, Inc. |
ClinicalTrials.gov Identifier: | NCT00051623 |
The purpose of this study is to determine if Infliximab is safe and effective in the treatment of psoriatic arthritis. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.
Condition | Intervention | Phase |
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Arthritis, Psoriatic |
Drug: Infliximab |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind Trial of Anti-TNFa Chimeric Monoclonal Antibody (Infliximab) for the Treatment of Patients With Psoriatic Arthritis |
Estimated Enrollment: | 200 |
Study Start Date: | May 2003 |
Study Completion Date: | June 2004 |
This is a phase III, multicenter, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled study designed to determine the safety and effectiveness of Infliximab in the treatment of patients with psoriatic arthritis. This is an experimental medical research study. A total of 200 people in North America and Europe participated in this study during the 17 month study period.Patients will receive infusions of either placebo or 5 or 10 mg/kg infliximab (Remicade) at weeks 0,2, 6, 14, 16, 18, 22, 30, 38, and 46.Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures.
Patients will receive either placebo or 5 mg/kg induction infusions (weeks 0, 2 and 6) followed by maintanance infusions every 8 weeks until week 46. In the placebo group, paients may early escape at week 16 and crossover at week 24 to infliximab;. In the 5mg/kg group, dose escalation if needed at week 38.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR004789 |
Study First Received: | January 14, 2003 |
Last Updated: | November 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00051623 |
Health Authority: | United States: Food and Drug Administration |
Remicade Psoriatic arthritis Infliximab |
Spinal Diseases Skin Diseases Arthritis, Psoriatic Infliximab Joint Diseases Spondylarthropathy Bone Diseases Antibodies, Monoclonal |
Antibodies Musculoskeletal Diseases Psoriasis Arthritis Spondylarthritis Skin Diseases, Papulosquamous Immunoglobulins Spondylarthropathies |
Anti-Inflammatory Agents Therapeutic Uses Gastrointestinal Agents |
Antirheumatic Agents Dermatologic Agents Pharmacologic Actions |