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A Clinical Trial of Infliximab for Uveitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00273390
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : July 4, 2011
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by:
Oregon Health and Science University

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
Uveitis Drug: Remicade (infliximab) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
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 : August 2001
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab





Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT00273390


Sponsors and Collaborators
Oregon Health and Science University
Centocor, Inc.
Investigators
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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
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00273390    
Other Study ID Numbers: e1473
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: July 4, 2011
Last Verified: January 2008
Additional relevant MeSH terms:
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Uveitis
Uveal Diseases
Eye Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents