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NCT00001614 · ClinicalTrials.gov registry record · Phase 1
The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid Arthritis
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT00001614 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 13 participants.
The verdict
NCT00001614, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
Current treatment modalities for uveitis associated with juvenile rheumatoid arthritis have not been beneficial in the juvenile population. A new approach for treating patients with presumed autoimmune disorders is oral tolerance therapy. Chicken type II collagen (Colloral) is being developed as an oral tolerance therapy for the treatment of rheumatoid arthritis. This open label pilot study will describe the safety of chicken type II collagen added to current anti-inflammatory medications as treatment for patients with uveitis associated with juvenile rheumatoid arthritis. The primary ophthalmic outcomes of this study will be a change from baseline in the number of anterior chamber cells and the number and dosage of anti-inflammatory medications. Secondary outcomes for JRA will include change in physician's global assessment, parent/patient assessment of overall well-being, functional assessment, number of joints with active arthritis, number of joints with limited range of motion, and erythrocyte sedimentation rate (ESR). Secondary outcomes for uveitis will include change in visual acuity, vitreous haze, and anterior chamber flare.
Interventions
- DRUG Chicken type II collagen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 1997-07 |
| Est. Completion | 2000-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001614
The ClinicalTrials.gov registry entry for NCT00001614 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Chicken type II collagen is the first listed.
NCT00001614 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001614 about?
NCT00001614 is a clinical study titled "The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid Arthritis". Current treatment modalities for uveitis associated with juvenile rheumatoid arthritis have not been beneficial in the juvenile population. A new approach for treating patients with presumed autoimmune disorders is oral tolerance therapy. Chicken type II collagen (Colloral) is being developed as an ...
What is the current status of trial NCT00001614?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 1997-07. Estimated completion is 2000-05.
What interventions are being tested in trial NCT00001614?
The interventions under investigation include: Chicken type II collagen (DRUG).
Who is sponsoring clinical trial NCT00001614?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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