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
  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.

Resource links provided by NLM:


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
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Patients receiving apremilast.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 B. Suhler, Principal Investigator, 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

Keywords provided by Oregon Health and Science University:
uveitis
apremilast

Additional relevant MeSH terms:
Chorioretinitis
Uveitis
Choroid Diseases
Choroiditis
Eye Diseases
Panuveitis
Retinal Diseases
Retinitis
Uveal Diseases
Uveitis, Posterior
Apremilast
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014