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A Clinical Trial of Infliximab for Uveitis

Sponsor
Oregon Health and Science University (Other)
Overall Status
Completed
CT.gov ID
NCT00273390
Collaborator
Centocor, Inc. (Industry)
32
Enrollment
64
Duration (Months)

Study Details

Study Description

Brief Summary

This project is designed to test the hypothesis that inhibition of binding between tumor necrosis factor alpha (TNF-alpha) and its receptors using Remicade (infliximab, chimeric mouse/human IgG1K monoclonal antibody directed against human TNF-alpha, Centocor, Malvern,PA) is clinically useful for patients with uveitis that is refractory to other forms of systemic immunosuppressive therapy.

Condition or Disease Intervention/Treatment Phase
  • Drug: Remicade (infliximab)
 N/A

Study Design

Study Type:
Interventional
Official Title:
The Use of Remicade (Infliximab) in the Management of Vision-threatening Uveitis That is Refractory to Other Modes of Systemic Immunosuppression
Study Start Date :
Aug 1, 2001
Actual Primary Completion Date :
Dec 1, 2006
Actual Study Completion Date :
Dec 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    9 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. The study group will include patients suffering from treatment-resistant vision-threatening uveitis who attend the Uveitis Clinic at Casey Eye Institute.

    2. We plan to enroll 32 patients.

    Exclusion Criteria:

    1. Patients with ocular or systemic infection.

    2. Patients with the subtype of uveitis termed pars planitis who have MRI scan evidence of demyelination. There is a theoretical risk of adverse outcome of TNF-alpha inhibition on the clinical course of multiple sclerosis. Patients who suffer from pars planitis are at increased risk of developing multiple sclerosis.

    3. Children under the age of 9.

    4. Patients with known sensitivity to mouse proteins. Remicade is a chimeric protein with human and murine components.

    5. Patients with history of cancer (exception- skin cancers which are curatively resected), organ transplantation (exception- cornea), recent drug or alcohol addiction, or inability to keep appointments.

    6. Patients with other serious systemic diseases that could interfere with participation in the study.

    7. It is specifically noted that pregnant women and nursing mothers will be excluded from this study.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Oregon Health and Science University
    • Centocor, Inc.

    Investigators

    • Principal Investigator: James T Rosenbaum, MD, Oregon Health and Science University
    • Study Director: Eric B Suhler, MD, Oregon Health and Science University
    • Study Director: Justine Smith, MBBS, Phd, Oregon Health and Science University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00273390
    Other Study ID Numbers:
    • e1473
    First Posted:
    Jan 9, 2006
    Last Update Posted:
    Jul 4, 2011
    Last Verified:
    Jan 1, 2008
    Additional relevant MeSH terms:
    Uveitis
    Infliximab

    Study Results

    No Results Posted as of Jul 4, 2011