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

April 24, 2009
June 6, 2014
November 2009
June 2011   (final data collection date for primary outcome measure)
  • Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50% [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Reduction in Cystoid Macular Edema [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50% [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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: 3 months ] [ Designated as safety issue: No ]
  • reduction in cystoid macular edema [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00889421 on ClinicalTrials.gov Archive Site
Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
type, frequency, severity, and relationship of adverse events to study treatment [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.

The purpose of this study is to assess the safety and efficacy of Apremilast in the treatment of uveitis.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Uveitis
Drug: Apremilast
oral dose of 30 mg BID for 6 months
Experimental: Treatment
Patients receiving apremilast.
Intervention: Drug: Apremilast
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00889421
e4235
Not Provided
Eric B. Suhler, Oregon Health and Science University
Oregon Health and Science University
Celgene Corporation
Principal Investigator: Eric B Suhler, MD, MPH Oregon Health and Science University
Oregon Health and Science University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP