The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoi… (NCT00001614) | Clinical Trial Compass
CompletedPhase 1
The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid Arthritis
United States13 participantsStarted 1997-07
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Must meet American College of Rheumatology Criteria for JRA.
Must have active anterior uveitis defined as the presence of inflammatory cells in the anterior chamber in at least one eye, or the current use of topical corticosteroids.
Must be between 2 and 18 years of age, inclusive.
Must have had previous therapy for uveitis.
Must be able to undergo a slit lamp biomicroscopy for assessment of anterior chamber cells.
Must not have a media opacity that precludes assessment of anterior chamber inflammation.
Must not have received a periocular injection of corticosteroids within 2 months of baseline.
Must not be currently receiving DMARD (disease modifying anti-rheumatic) therapy, with the exception of prednisone at a dose no greater than 1.5-2.0 mg/kg/day, or methotrexate at a dose no greater than 10 mg/m(2)/week.
Must not have active eye or joint inflammation requiring immediate addition or increase in systemic anti-inflammatory medications.
Must not have involvement in prior clinical trials of type II collagen.
Must not have exposure within the past year to shark or other collagen preparations found in health food stores.
Must not have a history of gastrointestinal disease which could affect the presentation of type II collagen.
Women must not be pregnant or lactating.
Patients currently using Latanoprost, patients who have used Latanoprost within the last 2 weeks, or patients who are likely to need Latanoprost during the course of the study will be excluded.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.