A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis
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Purpose
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 |
|---|---|---|
|
Giant Cell Arteritis |
Drug: Infliximab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Masked, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Infliximab in Subjects With Giant Cell Arteritis |
- The proportion of relapse-free patients through Week 22 .
- Proportion of relapse-free subjects through Week 54, time to first relapse, levels of biochemical markers of inflammation and disease activity (eg, ESR, C-reactive protein [CRP], interleukin [IL]-6) , cumulative dose of prednisone (or equivalents)
| Enrollment: | 44 |
| 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 infliximab 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 infliximab or placebo infusions at weeks 0, 2, 6, 14, 22, 30, 38, and 46.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients who have a diagnosis of Giant Cell Arteritis (GCA)
- Patients who have a diagnosis of GCA of = 4 weeks' duration
- Patients who are receiving = 40 mg/day of prednisone/prednisolone Exclusion Criteria:
- Patients must not have a prior diagnosis of GCA > 4 weeks
- Patients must not have failed to respond to glucocorticosteroid therapy within 5 days of initiation of therapy.
Contacts and Locations More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00076726 History of Changes |
| Other Study ID Numbers: | CR003139 |
| Study First Received: | February 2, 2004 |
| Last Updated: | May 16, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Centocor, Inc.:
|
Giant Cell Arteritis infliximab |
Additional relevant MeSH terms:
|
Arteritis Giant Cell Arteritis Polymyalgia Rheumatica Vascular Diseases Cardiovascular Diseases Vasculitis Vasculitis, Central Nervous System Autoimmune Diseases of the Nervous System Nervous System Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Skin Diseases, Vascular Skin Diseases |
Autoimmune Diseases Immune System Diseases Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Infliximab Dermatologic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013