A Clinical Trial of Infliximab for Uveitis

The Use of Remicade (Infliximab) in the Management of Vision-threatening Uveitis That is Refractory to Other Modes of Systemic Immunosuppression

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.

Study Overview

• Status: Completed
• Conditions: Uveitis
• Intervention / Treatment: Drug: Remicade (infliximab)

• Study Type: Interventional
• Enrollment: 32
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: 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

Publications and helpful links

General Publications

• 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. doi: 10.1001/archopht.123.7.903.
• Suhler EB, Smith JR, Giles TR, Lauer AK, Wertheim MS, Kurz DE, Kurz PA, Lim L, Mackensen F, Pickard TD, Rosenbaum JT. Infliximab therapy for refractory uveitis: 2-year results of a prospective trial. Arch Ophthalmol. 2009 Jun;127(6):819-22. doi: 10.1001/archophthalmol.2009.141. No abstract available.

Study record dates

Study Major Dates

• Study Start: August 1, 2001
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: January 5, 2006
• First Submitted That Met QC Criteria: January 5, 2006
• First Posted (Estimate): January 9, 2006

Study Record Updates

• Last Update Posted (Estimate): July 4, 2011
• Last Update Submitted That Met QC Criteria: July 1, 2011
• Last Verified: January 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Uveal Diseases; Uveitis; Antirheumatic Agents; Gastrointestinal Agents; Dermatologic Agents; Infliximab
• Other Study ID Numbers: e1473