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A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis
This study has been terminated.
Sponsors and Collaborators: Centocor, Inc.
The Cleveland Clinic
International Network for the Study of Systematic Vasculitides
Information provided by: Centocor, Inc.
ClinicalTrials.gov Identifier: NCT00076726
  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 II

MedlinePlus related topics: Polymyalgia Rheumatica
Drug Information available for: Infliximab
U.S. FDA Resources
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

Further study details as provided by Centocor, Inc.:

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

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 42
Study Start Date: November 2003
Study Completion Date: July 2005
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 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00076726

Sponsors and Collaborators
Centocor, Inc.
The Cleveland Clinic
International Network for the Study of Systematic Vasculitides
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

A Randomized, Double-masked, Placebo-controlled, Multicenter Study of the Safety and Efficacy of Infliximab in Subjects with Giant Cell Arteritis  This link exits the ClinicalTrials.gov site

Publications of Results:
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

Keywords provided by Centocor, Inc.:
Giant Cell Arteritis
infliximab

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 15, 2009