NCT00889421
Terminated
Phase 1
An Open-label Trial to Assess the Efficacy and Safety of Apremilast in the Management of Vision-threatening Uveitis That is Refractory to Other Modes of Systemic Immunosuppression.
Overview
- Phase
- Phase 1
- Intervention
- Apremilast
- Conditions
- Uveitis
- Sponsor
- Oregon Health and Science University
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
Brief Summary
The purpose of this study is to assess the safety and efficacy of Apremilast in the treatment of uveitis.
Investigators
Eric B. Suhler
Principal Investigator
Oregon Health and Science University
Eligibility Criteria
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
Arms & Interventions
Treatment
Patients receiving apremilast.
Intervention: Apremilast
Outcomes
Primary Outcomes
Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye
Time Frame: 6 months
Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%
Time Frame: 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)
Time Frame: 6 months
Reduction in Cystoid Macular Edema
Time Frame: 6 months
Secondary Outcomes
- Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment(7 months)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 4
Apremilast in the Treatment of Central Centrifugal Cicatricial Alopecia (CCCA)Central Centrifugal Cicatricial AlopeciaNCT03521687Icahn School of Medicine at Mount Sinai20
Unknown
Phase 2
Pilot Study of Apremilast (CC-10004) in the Treatment of Moderate to Severe Lichen PlanusLichen PlanusNCT01041625Virginia Clinical Research, Inc.10
Completed
Phase 2
Single Center Study of Apremilast for the Treatment of Hidradenitis SuppurativaHidradenitis SuppurativaNCT02695212Florida Academic Dermatology Centers20
Terminated
Not Applicable
A Study to Evaluate the Safety and Efficacy of Apremilast in the Treatment of Skin Disease in Patients With DermatomyositisDermatomyositisNCT01140503Stanford University5
Completed
Phase 3
A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Apremilast (CC-10004) in Subjects With Active Behçet's DiseaseBehçet's SyndromeNCT02307513Amgen207