The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001614
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: June 1999
  Purpose

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.


Condition Intervention Phase
Arthritis, Juvenile Rheumatoid
Uveitis
Drug: Chicken type II collagen
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 13
Study Start Date: July 1997
Estimated Study Completion Date: May 2000
Detailed Description:

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001614

Locations
United States, Maryland
National Eye Institute (NEI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001614     History of Changes
Other Study ID Numbers: 970146, 97-EI-0146
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Eye
Immunosuppression
Inflammation
Iritis
Joint
Oral Tolerance
Juvenile Rheumatoid Arthritis
Uveitis

Additional relevant MeSH terms:
Arthritis, Juvenile Rheumatoid
Arthritis
Arthritis, Rheumatoid
Uveitis
Chorioretinitis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis

ClinicalTrials.gov processed this record on July 20, 2014