A Clinical Trial of Infliximab for Uveitis

Uveitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00273390
• Other study ID #: e1473
• Status: Completed
• Phase: N/A
• First received: January 5, 2006
• Last updated: July 1, 2011
• Start date: August 2001
• Est. completion date: December 2006

Study information

• Verified date: January 2008
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years and older

Eligibility

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

N/A

Related Conditions & MeSH terms

• Uveitis

Intervention

Drug:
• Remicade (infliximab)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Centocor, Inc.

References & Publications (1)

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. — View Citation