search
Back to results

The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis

Primary Purpose

Uveitis, Arthritis, Juvenile Rheumatoid

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
TNFR:Fc
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis

Eligibility Criteria

2 Years - 18 Years (Child, 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 (Grade 1+ or higher) in the anterior chamber of at least one eye or the current use of topical corticosteroids to control exacerbation of disease at a frequency of TID or higher. Age between 2 and 18 years, inclusive. Ability to undergo slit lamp biomicroscopy for assessment of anterior chamber cells. Ability to comply with study requirements. Be up to date on all recommended childhood immunizations. Using current arthritis regimen for at least 8 weeks prior to enrollment. No media opacity that precludes assessment of anterior chamber inflammation. No periocular injection of corticosteroids within 2 months of baseline, or used a systemic experimental therapy within one month of baseline evaluation. Not currently receiving disease modifying antirheumatic therapy (DMARD), with the exception of prednisone at a dose no greater than 1.0 mg/kg/day, or methotrexate at a dose no greater than 15 mg/m(2)/week. No active eye or joint inflammation requiring immediate addition or increase in systemic anti-inflammatory medications. No females who are pregnant or lactating. No refusal to use contraception during the study and 6 months after termination of active study therapy, if child-bearing or fathering potential exists. No use of Latanoprost within two weeks prior to enrollment, or have a current or likely need for Latanoprost during the course of the study. No hypersensitivity to fluorescein dye. No active serious infections or history of recurring serious infections. No evidence of spondyloarthropathy or entheseopathy.

Sites / Locations

  • National Institutes of HealthRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 10, 2001
Last Updated
June 23, 2005
Sponsor
National Eye Institute (NEI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00012506
Brief Title
The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2001
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Eye Institute (NEI)

4. Oversight

5. Study Description

Brief Summary
This study will investigate the safety and effectiveness of the drug Enbrel (TNFR:Fc) to treat uveitis (eye inflammation) in patients with juvenile rheumatoid arthritis.
Detailed Description
In other studies, TNFR:Fc significantly reduced joint pain and swelling in adult patients with rheumatoid arthritis, and the Food and Drug Administration has approved the drug for that use. Because medicines for arthritis often help patients with eye inflammation, this study will examine whether TNFR:Fc can help patients with uveitis. Patients with uveitis who are not responding well to standard treatment, such as steroids, and patients who have side effects from other medicines used to treat their uveitis or have refused treatment because of possible side effects may be eligible for this study. Candidates will be screened with a medical history, physical examination, and eye examination. The eye exam includes a check of vision and eye pressure, examination of the back of the eye (retina), and front of the eye, including measurements of protein and inflammation. Candidates will also undergo fluorescein angiography-a procedure in which photographs are taken of the retina to see if there is any leakage in the eye's blood vessels. A blood test and joint evaluation will also be done. Study participants will be given an injection of TNFR:Fc twice a week for up to 12 months and may continue other medicines they may be taking, such as prednisone or methotrexate. They will have follow-up examinations at week two and months one, two, three and four. Those who wish to continue treatment after the fourth month can receive the drug for another eight months and will have follow-up exams at months six, nine and 12, and one month after treatment ends. Each follow-up visit will include a repeat of the screening exams and an evaluation of side effects or discomfort from the medicine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Arthritis, Juvenile Rheumatoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
TNFR:Fc

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
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 (Grade 1+ or higher) in the anterior chamber of at least one eye or the current use of topical corticosteroids to control exacerbation of disease at a frequency of TID or higher. Age between 2 and 18 years, inclusive. Ability to undergo slit lamp biomicroscopy for assessment of anterior chamber cells. Ability to comply with study requirements. Be up to date on all recommended childhood immunizations. Using current arthritis regimen for at least 8 weeks prior to enrollment. No media opacity that precludes assessment of anterior chamber inflammation. No periocular injection of corticosteroids within 2 months of baseline, or used a systemic experimental therapy within one month of baseline evaluation. Not currently receiving disease modifying antirheumatic therapy (DMARD), with the exception of prednisone at a dose no greater than 1.0 mg/kg/day, or methotrexate at a dose no greater than 15 mg/m(2)/week. No active eye or joint inflammation requiring immediate addition or increase in systemic anti-inflammatory medications. No females who are pregnant or lactating. No refusal to use contraception during the study and 6 months after termination of active study therapy, if child-bearing or fathering potential exists. No use of Latanoprost within two weeks prior to enrollment, or have a current or likely need for Latanoprost during the course of the study. No hypersensitivity to fluorescein dye. No active serious infections or history of recurring serious infections. No evidence of spondyloarthropathy or entheseopathy.
Facility Information:
Facility Name
National Institutes of Health
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan H Smith
Phone
391-435-4559
Email
smithsmith@intra.nei.nih.gov
First Name & Middle Initial & Last Name & Degree
Janine A Smith, M.D.

12. IPD Sharing Statement

Learn more about this trial

The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis

We'll reach out to this number within 24 hrs