TNRF:Fc to Treat Eye Inflammation in Juvenile Rheumatoid Arthritis

NCT00001862 | Completed Phase 2

• 2 other identifiers: 99004799-EI-0047
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Juvenile Rheumatoid Arthritis; Uveitis

Keywords

Ocular Inflammation; Children; Immunotherapy; Cytokine; Clinical Trial; Uveitis; Immunosuppression; Joint; Inflammation

Interventions

Enbrel DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Eye Institute (NEI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 3547655 BACKGROUND

• 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.

  PMID: 3684202 BACKGROUND

• Smiley WK. The eye in juvenile rheumatoid arthritis. Trans Ophthalmol Soc U K (1962). 1974 Sep;94(3):817-29. No abstract available.

  PMID: 4549593 BACKGROUND

MeSH Terms

Conditions

Arthritis, Juvenile; Uveitis; Inflammation

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Uveal Diseases; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: February 1, 1999
• Study Completion: March 1, 2003
• Last Updated: March 4, 2008

Record last verified: 2003-03

Locations

US (1)