- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001614
The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid Arthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Eye Institute (NEI)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Trentham DE, Dynesius-Trentham RA, Orav EJ, Combitchi D, Lorenzo C, Sewell KL, Hafler DA, Weiner HL. Effects of oral administration of type II collagen on rheumatoid arthritis. Science. 1993 Sep 24;261(5129):1727-30. doi: 10.1126/science.8378772.
- Rosenberg AM. Uveitis associated with juvenile rheumatoid arthritis. Semin Arthritis Rheum. 1987 Feb;16(3):158-73. doi: 10.1016/0049-0172(87)90019-9.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 970146
- 97-EI-0146
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Uveitis
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Priovant Therapeutics, Inc.Active, not recruitingNon-infectious Intermediate Uveitis | Non-infectious Posterior Uveitis | Non-infectious Pan UveitisUnited States
-
University of NebraskaUnknownPosterior Uveitis | Intermediate Uveitis | Pan-uveitisUnited States
-
Stanford UniversitySanten Inc.WithdrawnPanuveitis | Uveitis | Posterior Uveitis | Intermediate UveitisUnited States
-
EyePoint Pharmaceuticals, Inc.CompletedPanuveitis | Posterior Uveitis | Intermediate UveitisIndia
-
Johns Hopkins UniversityMacuSight, Inc.CompletedPanuveitis | Uveitis | Posterior Uveitis | Intermediate UveitisUnited States
-
CHU de Quebec-Universite LavalCompletedIntermediate Uveitis | Anterior UveitisCanada
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Novartis PharmaceuticalsCompletedNon-infectious Intermediate Uveitis | Non-infectious Posterior Uveitis | Non-infectious PanuveitisUnited States, United Kingdom
-
The New York Eye & Ear InfirmaryUnknownPanuveitis | Uveitis | Posterior Uveitis | Anterior UveitisUnited States
-
Duke UniversityCompletedPosterior Uveitis | Intermediate UveitisUnited States
-
AllerganCompletedPosterior Uveitis | Intermediate UveitisFrance, United Kingdom, United States, Spain, Poland, India, South Africa, Korea, Republic of, Canada, Czech Republic, Australia, Germany, Israel, Switzerland, Portugal, Austria, Brazil, Greece
Clinical Trials on Chicken type II collagen
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BioibericaRecruiting
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University of TennesseeNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed
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Chulalongkorn UniversityNot yet recruiting
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Shan May YongChang Gung Memorial HospitalCompleted
-
Vedic Lifesciences Pvt. Ltd.Recruiting
-
NovoBliss Research Pvt LtdCollagen Lifesciences Private LimitedCompletedHealthy | Osteoarthritis, Knee | Brittle Nails | Mild to Moderate Acne | Stiffness of Joint, Nec, Involving Ankle and Foot in MDR24_1 | Other Specified Diseases of Hair and Hair FolliclesIndia
-
Janette Furuzawa CarballedaRecruitingCovid19 | Pulmonary Fibrosis | Cytokine Storm | Regulation of Inflammatory ResponseMexico
-
TCI Co., Ltd.Completed
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National Institute of Arthritis and Musculoskeletal...Medical University of South Carolina; Johns Hopkins University; University of... and other collaboratorsCompletedConnective Tissue Diseases | SclerodermaUnited States
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Postgraduate Institute of Dental Sciences RohtakUnknownPeriapical Lesions