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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Notify MeKey information
Conditions
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
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.
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