A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis
Primary Purpose
Giant Cell Arteritis
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Infliximab
Sponsored by
About this trial
This is an interventional treatment trial for Giant Cell Arteritis focused on measuring Giant Cell Arteritis, infliximab
Eligibility 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.
Sites / Locations
Outcomes
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)
Full Information
NCT ID
NCT00076726
First Posted
February 2, 2004
Last Updated
May 16, 2011
Sponsor
Centocor, Inc.
Collaborators
The Cleveland Clinic
1. Study Identification
Unique Protocol Identification Number
NCT00076726
Brief Title
A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis
Official Title
A Randomized, Double-Masked, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Infliximab in Subjects With Giant Cell Arteritis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis, infliximab did not reduce number of first relapses in GCA or cumulative glucocorticosteroid dosage
Study Start Date
November 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centocor, Inc.
Collaborators
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Giant Cell Arteritis
Keywords
Giant Cell Arteritis, infliximab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Infliximab
Primary Outcome Measure Information:
Title
The proportion of relapse-free patients through Week 22 .
Secondary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Centocor, Inc. Clinical Trial
Organizational Affiliation
Centocor, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17470830
Citation
Hoffman GS, Cid MC, Rendt-Zagar KE, Merkel PA, Weyand CM, Stone JH, Salvarani C, Xu W, Visvanathan S, Rahman MU; Infliximab-GCA Study Group. Infliximab for maintenance of glucocorticosteroid-induced remission of giant cell arteritis: a randomized trial. Ann Intern Med. 2007 May 1;146(9):621-30. doi: 10.7326/0003-4819-146-9-200705010-00004.
Results Reference
result
PubMed Identifier
21873264
Citation
Visvanathan S, Rahman MU, Hoffman GS, Xu S, Garcia-Martinez A, Segarra M, Lozano E, Espigol-Frigole G, Hernandez-Rodriguez J, Cid MC. Tissue and serum markers of inflammation during the follow-up of patients with giant-cell arteritis--a prospective longitudinal study. Rheumatology (Oxford). 2011 Nov;50(11):2061-70. doi: 10.1093/rheumatology/ker163. Epub 2011 Aug 25.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=145&filename=CR003139_CSR.pdf
Description
A Randomized, Double-masked, Placebo-controlled, Multicenter Study of the Safety and Efficacy of Infliximab in Subjects with Giant Cell Arteritis
Learn more about this trial
A Study of the Safety and Effectiveness of Infliximab (Remicade) in Patients With Giant Cell Arteritis
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