A Clinical Trial of Infliximab for Uveitis

Not Applicable

Completed

• Conditions: Uveitis

• Registration Number: NCT00273390
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-08
• Study First Submitted: 2006-01-05
• Study First Submitted QC: 2006-01-05
• Study First Posted: 2006-01-09
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2008-01
• Last Update Submitted: 2011-07-01
• Last Update Posted: 2011-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified