Apremilast in the Treatment of Uveitis
- Registration Number
- NCT00889421
- Lead Sponsor
- Oregon Health and Science University
- Brief Summary
The purpose of this study is to assess the safety and efficacy of Apremilast in the treatment of uveitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 3
Inclusion Criteria
- patients with vision-threatening autoimmune uveitis
- failure to respond to prednisone and at least one other systemic immunosuppressive, or intolerance to such medications due to side effects
Exclusion Criteria
- serious concomitant illness that could interfere with the subject's participation
- previous or current use of an alkylating agent
- use of CYP3A4 inhibitors during the trial
- TNF blocker use within the 8 weeks prior to enrollment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Apremilast Patients receiving apremilast.
- Primary Outcome Measures
Name Time Method Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye 6 months Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50% 6 months Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods (Reduction of Anterior Chamber Cellular Activity and/or Chorioretinal Infiltrates and/or Retinal Vasculitis) 6 months Reduction in Cystoid Macular Edema 6 months
- Secondary Outcome Measures
Name Time Method Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment 7 months
Trial Locations
- Locations (1)
Oregon Health & Science University
🇺🇸Portland, Oregon, United States