A Clinical Trial of Infliximab for Uveitis

NCT00273390 | Completed

• 1 other identifier: e1473
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Uveitis

Interventions

Remicade (infliximab) DRUG

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Centocor, Inc.: collaborator

Related Publications (2)

• 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.

  PMID: 16009830 RESULT

• 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.

  PMID: 19506209 DERIVED

MeSH Terms

Conditions

Uveitis

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• James T Rosenbaum, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Eric B Suhler, MD

  Oregon Health and Science University

  STUDY DIRECTOR

• Justine Smith, MBBS, Phd

  Oregon Health and Science University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 5, 2006
• First Posted: January 9, 2006
• Study Start: August 1, 2001
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: July 4, 2011

Record last verified: 2008-01