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Sponsors and Collaborators: |
Centocor, Inc. The Cleveland Clinic International Network for the Study of Systematic Vasculitides |
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Information provided by: | Centocor, Inc. |
ClinicalTrials.gov Identifier: | NCT00076726 |
The purpose of this study is to evaluate the safety and efficacy (effectiveness) of Infliximab (Remicade) in patients with Giant Cell Arteritis. 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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Giant Cell Arteritis |
Drug: Infliximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized, Double-Masked, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Infliximab in Subjects With Giant Cell Arteritis |
Estimated Enrollment: | 42 |
Study Start Date: | November 2003 |
Study Completion Date: | July 2005 |
The purpose of this study is to see if infliximab is safe and effective in treating GCA. Currently, the only treatment for GCA is prednisone. GCA is a long lasting inflammatory disease. The cause is unknown. It may affect all the arteries, but it focuses on the big vessels such as those around the heart, the vessels in the neck and head, and their major branches. It can lead to vision loss, blindness, stroke, stenosis (narrowing of blood vessels) and aneurysms (a weakening in the lining of the blood vessel wall, which may eventually lead to rupture of the blood vessel). The damage to the arteries is caused by an immune response. A naturally occurring substance in the immune system called "tumor necrosis factor alpha" (TNFa) plays a significant role in this immune response against the blood vessels. This response is thought to cause the long-lasting inflammation (irritation and swelling of the vessels). By blocking the effect of TNFa we think that we may reduce the signs and symptoms associated with GCA. This trial will study patients who are stable on prednisone treatment by evaluating whether infliximab can control their symptoms as the dose of prednisone is reduced. Patients will receive infusions of either 5mg/kg of inflixmab or placebo at weeks 0, 2, 6, 14, 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 receive infusions of either 5mg/kg inflixmab or placebo infusions at weeks 0, 2, 6, 14, 22, 30, 38, and 46.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | CR003139 |
Study First Received: | February 2, 2004 |
Last Updated: | April 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00076726 |
Health Authority: | United States: Food and Drug Administration |
Giant Cell Arteritis infliximab |
Temporal arteritis Vasculitis Autoimmune Diseases Skin Diseases Infliximab Vascular Diseases Central Nervous System Diseases Rheumatic Diseases Brain Diseases |
Cerebrovascular Disorders Horton’s disease Muscular Diseases Musculoskeletal Diseases Polymyalgia Rheumatica Giant Cell Arteritis Connective Tissue Diseases Arteritis Autoimmune Diseases of the Nervous System |
Anti-Inflammatory Agents Skin Diseases, Vascular Immune System Diseases Therapeutic Uses Nervous System Diseases Gastrointestinal Agents |
Cardiovascular Diseases Vasculitis, Central Nervous System Antirheumatic Agents Dermatologic Agents Pharmacologic Actions |