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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
Centocor, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Giant Cell Arteritis focused on measuring Giant Cell Arteritis, infliximab

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    February 2, 2004
    Last Updated
    May 16, 2011
    Sponsor
    Centocor, Inc.
    Collaborators
    The Cleveland Clinic
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    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

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

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