A Clinical Trial of Infliximab for Uveitis - Full Text View

Sponsors and Collaborators:	Oregon Health and Science University Centocor, Inc.
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00273390

Purpose

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	Intervention
Uveitis	Drug: Remicade (infliximab)

Drug Information available for: Infliximab

U.S. FDA Resources

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

Further study details as provided by Oregon Health and Science University:

Estimated Enrollment:	32
Study Start Date:	August 2001
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	9 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The study group will include patients suffering from treatment-resistant vision-threatening uveitis who attend the Uveitis Clinic at Casey Eye Institute.
We plan to enroll 32 patients.

Exclusion Criteria:

Patients with ocular or systemic infection.
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.
Children under the age of 9.
Patients with known sensitivity to mouse proteins. Remicade is a chimeric protein with human and murine components.
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.
Patients with other serious systemic diseases that could interfere with participation in the study.
It is specifically noted that pregnant women and nursing mothers will be excluded from this study.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00273390

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

More Information

Publications of Results:

Suhler EB, Smith JR, Wertheim MS, Lauer AK, Kurz DE, Pickard TD, Rosenbaum JT. A prospective trial of infliximab therapy for refractory uveitis: preliminary safety and efficacy outcomes. Arch Ophthalmol. 2005 Jul;123(7):903-12.

Study ID Numbers:	e1473
Study First Received:	January 5, 2006
Last Updated:	February 6, 2008
ClinicalTrials.gov Identifier:	NCT00273390
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Infliximab
Uveitis
Eye Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Uveal Diseases
Therapeutic Uses
Gastrointestinal Agents

Antirheumatic Agents
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009