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OpenTrials
Completed

NCT Number: NCT00273390

A Clinical Trial of Infliximab for Uveitis

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.

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Key information

Age range

9 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Remicade (infliximab)

Drug

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Centocor, Inc.

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Jan 9, 2006
Registry last updated
Jul 4, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.