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A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis

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ClinicalTrials.gov Identifier: NCT00076726
Recruitment Status : Terminated (Interim analysis, infliximab did not reduce number of first relapses in GCA or cumulative glucocorticosteroid dosage)
First Posted : February 4, 2004
Last Update Posted : May 17, 2011
The Cleveland Clinic
Information provided by:
Centocor, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Giant Cell Arteritis Drug: Infliximab Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : November 2003
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Primary Outcome Measures :
  1. The proportion of relapse-free patients through Week 22 .

Secondary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00076726

Sponsors and Collaborators
Centocor, Inc.
The Cleveland Clinic
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Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00076726    
Other Study ID Numbers: CR003139
First Posted: February 4, 2004    Key Record Dates
Last Update Posted: May 17, 2011
Last Verified: April 2010
Keywords provided by Centocor, Inc.:
Giant Cell Arteritis
Additional relevant MeSH terms:
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Polymyalgia Rheumatica
Giant Cell Arteritis
Vascular Diseases
Cardiovascular Diseases
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
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents