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

Primary Purpose

Arthritis, Juvenile Rheumatoid, Uveitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Chicken type II collagen
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthritis, Juvenile Rheumatoid focused on measuring Eye, Immunosuppression, Inflammation, Iritis, Joint, Oral Tolerance, Juvenile Rheumatoid Arthritis, Uveitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Eye Institute (NEI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001614
Brief Title
The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid Arthritis
Official Title
The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 1999
Overall Recruitment Status
Completed
Study Start Date
July 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2000 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Eye Institute (NEI)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Juvenile Rheumatoid, Uveitis
Keywords
Eye, Immunosuppression, Inflammation, Iritis, Joint, Oral Tolerance, Juvenile Rheumatoid Arthritis, Uveitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
13 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Chicken type II collagen

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
National Eye Institute (NEI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8378772
Citation
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.
Results Reference
background
PubMed Identifier
3547655
Citation
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.
Results Reference
background

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

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