Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis
- Registration Number
- NCT00525902
- Lead Sponsor
- Oregon Health and Science University
- Brief Summary
The purpose of this study is to assess the safety and efficacy of Adalimumab in uveitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
- Patients with vision-threatening autoimmune uveitis.
- Failure to respond to prednisone and at least one other systemic immunosuppressive (such as methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, cyclophosphamide, or chlorambucil), or intolerance to such medications due to side effects.
Exclusion Criteria
- Serious concomitant illness that could interfere with the subject's participation in the trial.
- Previous or current use of cyclophosphamide.
- Unable or unwilling to undergo multiple injections.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Adalimumab Adalimumab -
- Primary Outcome Measures
Name Time Method Cumulative Endpoint 50 Weeks Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Oregon Health & Science University
🇺🇸Portland, Oregon, United States