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Apremilast in the Treatment of Uveitis

This study has been withdrawn prior to enrollment.
(Investigator discretion due to lack of efficacy in three subjects enrolled)
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00889421
First received: April 24, 2009
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Uveitis
 Drug: Apremilast
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • type, frequency, severity, and relationship of adverse events to study treatment [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Enrollment: 3
Study Start Date: November 2009
Study Completion Date: June 2011
Intervention Details:
    Drug: Apremilast
    oral dose of 30 mg BID for 6 months
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889421

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Celgene Corporation
Investigators
Principal Investigator: Eric B Suhler, MD, MPH Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Eric Suhler, MD, MPH, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00889421     History of Changes
Other Study ID Numbers: e4235
Study First Received: April 24, 2009
Last Updated: July 20, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Oregon Health and Science University:
uveitis
apremilast

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Retinitis
 Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis

ClinicalTrials.gov processed this record on May 22, 2013