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TNRF:Fc to Treat Eye Inflammation in Juvenile Rheumatoid Arthritis

Primary Purpose

Juvenile Rheumatoid Arthritis, Uveitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Enbrel
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Rheumatoid Arthritis focused on measuring Ocular Inflammation, Children, Immunotherapy, Cytokine, Clinical Trial, Uveitis, Immunosuppression, Joint, Inflammation

Eligibility Criteria

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

INCLUSION CRITERIA: Meet American College of Rheumatology Criteria for JRA. 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. Be between 2 and 18 years, inclusive. Be able to undergo slit lamp biomicroscopy for assessment of anterior chamber cells. Be able to comply with study requirements. Be up to date on all recommended childhood immunizations. Have been using current arthritis regimen for at least 8 weeks prior to enrollment. EXCLUSION CRITERIA: Have a media opacity that precludes assessment of anterior chamber inflammation. Have a periocular injection of corticosteroids within 2 months of baseline, or used a systemic experimental therapy within one month of baseline evaluation. Be 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. Have active eye or joint inflammation requiring immediate addition or increase in systemic anti-inflammatory medications. Be a Female who is pregnant or lactating . Refuse to use contraception during the study and 6 months after termination of active study therapy, if child-bearing or fathering potential exists. Have used Latanoprost within two weeks prior to enrollment, or have a current or likely need for Latanoprost during the course of the study. Have hypersensitivity to fluorescein dye. Have active serious infections or history of recurring serious infections. Evidence of spondyloarthropathy or entheseopathy.

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
NCT00001862
Brief Title
TNRF:Fc to Treat Eye Inflammation in Juvenile Rheumatoid Arthritis
Official 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 2003
Overall Recruitment Status
Completed
Study Start Date
February 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2003 (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 TNFR:Fc to treat uveitis (eye inflammation) in patients with juvenile rheumatoid arthritis. 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 a shot 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.
Detailed Description
Current treatment modalities for uveitis associated with Juvenile Rheumatoid Arthritis (JRA) including corticosteroids and other immunosuppressive agents are associated with significant side effects. These treatments are not effective for all children. A soluble tumor necrosis factor receptor (TNFR:Fc) named Etanercept, may inhibit the inflammatory response of uveitis. This randomized double-masked phase I/II clinical trial will provide limited safety and efficacy information regarding the use of Etanercept for the treatment of uveitis associated with JRA. Fifteen patients will be randomized with a 2 to 1 randomization plan (10 to receive Etanercept, 5 to receive placebo) and followed for 6 months. After the 6 month visit, all patients will receive open label Etanercept for an additional 6 months. Patients will be switched to open label Etanercept, or withdrawn from study therapy prior to 6 months, if they a) experience a greater than 10 letter or greater drop in visual acuity due to inflammation, for patients using the ETDRS chart (a 2 line drop due to inflammation, for patients using the B-VAT method) or b) develop a sight-threatening inflammatory ophthalmic or joint lesion requiring immediate increase in systemic anti-inflammatory therapy or a periocular injection of corticosteriods or c) at 4 months, have greater than 1 plus anterior chamber cell grade in either eye and are receiving topical corticosteroids on a schedule of TID or more frequently. Investigators will remain masked to original treatment assignment unless warranted by clinical care considerations. Primary safety outcomes include the occurrence of any severe adverse event at least possibly related to study therapy, including a two step increase in anterior chamber cells, or the occurrence of serious infection or sepsis. Primary ophthalmic outcomes include measures of anterior chamber cells and a change in topical or systemic anti-inflammatory medications used to treat uveitis. Primary ophthalmic and JRA outcome analysis will be performed at 6 months, and again at 12 months. Patients unmasked or switched to open label Etanercept prior to month 6 or withdrawing from the study drug prior to month 12 will be considered failures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Rheumatoid Arthritis, Uveitis
Keywords
Ocular Inflammation, Children, Immunotherapy, Cytokine, Clinical Trial, Uveitis, Immunosuppression, Joint, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
15 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Enbrel

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA: Meet American College of Rheumatology Criteria for JRA. 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. Be between 2 and 18 years, inclusive. Be able to undergo slit lamp biomicroscopy for assessment of anterior chamber cells. Be able to comply with study requirements. Be up to date on all recommended childhood immunizations. Have been using current arthritis regimen for at least 8 weeks prior to enrollment. EXCLUSION CRITERIA: Have a media opacity that precludes assessment of anterior chamber inflammation. Have a periocular injection of corticosteroids within 2 months of baseline, or used a systemic experimental therapy within one month of baseline evaluation. Be 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. Have active eye or joint inflammation requiring immediate addition or increase in systemic anti-inflammatory medications. Be a Female who is pregnant or lactating . Refuse to use contraception during the study and 6 months after termination of active study therapy, if child-bearing or fathering potential exists. Have used Latanoprost within two weeks prior to enrollment, or have a current or likely need for Latanoprost during the course of the study. Have hypersensitivity to fluorescein dye. Have active serious infections or history of recurring serious infections. Evidence of spondyloarthropathy or entheseopathy.
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
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
PubMed Identifier
3684202
Citation
Wolf MD, Lichter PR, Ragsdale CG. Prognostic factors in the uveitis of juvenile rheumatoid arthritis. Ophthalmology. 1987 Oct;94(10):1242-8. doi: 10.1016/s0161-6420(87)80007-6.
Results Reference
background
PubMed Identifier
4549593
Citation
Smiley WK. The eye in juvenile rheumatoid arthritis. Trans Ophthalmol Soc U K (1962). 1974 Sep;94(3):817-29. No abstract available.
Results Reference
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TNRF:Fc to Treat Eye Inflammation in Juvenile Rheumatoid Arthritis

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