The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT00012506|
Recruitment Status : Unknown
Verified March 2001 by National Eye Institute (NEI).
Recruitment status was: Recruiting
First Posted : March 12, 2001
Last Update Posted : June 24, 2005
|First Submitted Date ICMJE||March 10, 2001|
|First Posted Date ICMJE||March 12, 2001|
|Last Update Posted Date||June 24, 2005|
|Study Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis|
|Official Title ICMJE||Not Provided|
|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.|
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.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 3|
|Study Design ICMJE||Primary Purpose: Treatment|
|Intervention ICMJE||Drug: TNFR:Fc|
|Study Arms ICMJE||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Enrollment ICMJE||Not Provided|
|Original Enrollment ICMJE||Not Provided|
|Study Completion Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
|Ages ICMJE||2 Years to 18 Years (Child, Adult)|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00012506|
|Other Study ID Numbers ICMJE||NEI-82|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Eye Institute (NEI)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||National Eye Institute (NEI)|
|Verification Date||March 2001|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP