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Home > "T" Clinical Trials Conditions > The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated with Juvenile Rheumatoid Arthritis  The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated with Juvenile Rheumatoid Arthritis
The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated with Juvenile Rheumatoid Arthritis
For Condition: Arthritis, Juvenile Rheumatoid,Uveitis
Status: Completed
Sponsor(s): National Eye Institute (NEI) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 13
Location and Contact Information:
National Eye Institute (NEI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 970146; 97-EI-0146
Study Start Date: July 9, 1997
Record last reviewed: June 16, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001614
Other Uveitis Studies:
1. Vitamin E to Treat Uveitis-Associated Macular Edema
2. Safety and Efficacy of a Heparin-Coated Intraocular Lens in Uveitis
3. The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated with Juvenile Rheumatoid Arthritis
4. The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated with Juvenile Rheumatoid Arthritis
5. Screening for NEI Clinical Studies
Related Studies:
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Other Maryland Clinical Trials
Other Bethesda Clinical Trials
The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated with Juvenile Rheumatoid Arthritis
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