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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2001 by National Eye Institute (NEI).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00012506
First Posted: March 12, 2001
Last Update Posted: June 24, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Eye Institute (NEI)
  Purpose
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.

Condition Intervention Phase
Uveitis Arthritis, Juvenile Rheumatoid Drug: TNFR:Fc Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Eye Institute (NEI):

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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 (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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00012506


Locations
United States, Maryland
National Institutes of Health Recruiting
Bethesda, Maryland, United States, 20892
Contact: Susan H Smith    391-435-4559    smithsmith@intra.nei.nih.gov   
Principal Investigator: Janine A Smith, M.D.         
Sponsors and Collaborators
National Eye Institute (NEI)
  More Information

ClinicalTrials.gov Identifier: NCT00012506     History of Changes
Other Study ID Numbers: NEI-82
First Submitted: March 10, 2001
First Posted: March 12, 2001
Last Update Posted: June 24, 2005
Last Verified: March 2001

Additional relevant MeSH terms:
Arthritis
Uveitis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Uveal Diseases
Eye Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases