Study Stopped
Investigator discretion due to lack of efficacy in three subjects enrolled
Apremilast in the Treatment of Uveitis
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.
1 other identifier
interventional
3
1 country
1
Brief Summary
The purpose of this study is to assess the safety and efficacy of Apremilast in the treatment of uveitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2009
CompletedFirst Posted
Study publicly available on registry
April 28, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
July 8, 2014
CompletedJuly 8, 2014
June 1, 2014
1.6 years
April 24, 2009
June 6, 2014
June 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (1)
Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment
7 months
Study Arms (1)
Treatment
EXPERIMENTALPatients receiving apremilast.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- Celgene Corporationcollaborator
Study Sites (1)
Oregon Health & Science University
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study was terminated prematurely due to inefficacy in the three initial patients enrolled. Endpoints were not analyzed as participants did not make it to the 6 month time frame before discontinuing the study.
Results Point of Contact
- Title
- Dr. Eric Suhler
- Organization
- Oregon Health & Science University
Study Officials
- PRINCIPAL INVESTIGATOR
Eric B Suhler, MD, MPH
Oregon Health and Science University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 24, 2009
First Posted
April 28, 2009
Study Start
November 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
July 8, 2014
Results First Posted
July 8, 2014
Record last verified: 2014-06