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Apremilast in the Treatment of Uveitis

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ClinicalTrials.gov Identifier: NCT00889421
Recruitment Status : Terminated (Investigator discretion due to lack of efficacy in three subjects enrolled)
First Posted : April 28, 2009
Results First Posted : July 8, 2014
Last Update Posted : July 8, 2014
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Eric B. Suhler, Oregon Health and Science University

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

Condition or disease Intervention/treatment Phase
Uveitis Drug: Apremilast Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : November 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Apremilast

Arm Intervention/treatment
Experimental: Treatment
Patients receiving apremilast.
Drug: Apremilast
oral dose of 30 mg BID for 6 months




Primary Outcome Measures :
  1. Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye [ Time Frame: 6 months ]
  2. Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50% [ Time Frame: 6 months ]
  3. 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. Reduction in Cystoid Macular Edema [ Time Frame: 6 months ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Eric B. Suhler, Principal Investigator, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00889421     History of Changes
Other Study ID Numbers: e4235
First Posted: April 28, 2009    Key Record Dates
Results First Posted: July 8, 2014
Last Update Posted: July 8, 2014
Last Verified: June 2014

Keywords provided by Eric B. Suhler, Oregon Health and Science University:
uveitis
apremilast

Additional relevant MeSH terms:
Uveitis
Uveal Diseases
Eye Diseases
Apremilast
Thalidomide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents