Back to resultsApremilast in the Treatment of Uveitis
Primary Purpose
Uveitis
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Apremilast
Sponsored by
About this trial
This is an interventional treatment trial for Uveitis focused on measuring uveitis, apremilast
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
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Patients receiving apremilast.
Outcomes
Primary Outcome Measures
Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye
Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%
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)
Reduction in Cystoid Macular Edema
Secondary Outcome Measures
Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment
Full Information
NCT ID
NCT00889421
First Posted
April 24, 2009
Last Updated
June 6, 2014
Sponsor
Oregon Health and Science University
Collaborators
Celgene Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00889421
Brief Title
Apremilast in the Treatment of Uveitis
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
Investigator discretion due to lack of efficacy in three subjects enrolled
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Celgene Corporation
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and efficacy of Apremilast in the treatment of uveitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis
Keywords
uveitis, apremilast
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients receiving apremilast.
Intervention Type
Drug
Intervention Name(s)
Apremilast
Intervention Description
oral dose of 30 mg BID for 6 months
Primary Outcome Measure Information:
Title
Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye
Time Frame
6 months
Title
Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%
Time Frame
6 months
Title
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
Title
Reduction in Cystoid Macular Edema
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment
Time Frame
7 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric B Suhler, MD, MPH
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Apremilast in the Treatment of Uveitis
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