Apremilast in the Treatment of Uveitis

This study has been terminated.
(Investigator discretion due to lack of efficacy in three subjects enrolled)
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Eric B. Suhler, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00889421
First received: April 24, 2009
Last updated: June 6, 2014
Last verified: June 2014
Results First Received: June 6, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Uveitis
Intervention: Drug: Apremilast

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment Patient receiving apremilast.

Participant Flow:   Overall Study
    Treatment  
STARTED     3  
COMPLETED     0  
NOT COMPLETED     3  
Lack of Efficacy                 3  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
patients with refractory uveitis

Reporting Groups
  Description
Treatment Patient receiving apremilast.

Baseline Measures
    Treatment  
Number of Participants  
[units: participants]
  3  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     0  
Gender  
[units: participants]
 
Female     2  
Male     1  
Region of Enrollment  
[units: participants]
 
United States     3  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye   [ Time Frame: 6 months ]

2.  Primary:   Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%   [ Time Frame: 6 months ]

3.  Primary:   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 ]

4.  Primary:   Reduction in Cystoid Macular Edema   [ Time Frame: 6 months ]

5.  Secondary:   Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment   [ Time Frame: 7 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Eric Suhler
Organization: Oregon Health & Science University
phone: 503-494-5023
e-mail: suhlere@ohsu.edu


No publications provided


Responsible Party: Eric B. Suhler, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00889421     History of Changes
Other Study ID Numbers: e4235
Study First Received: April 24, 2009
Results First Received: June 6, 2014
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration