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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00889421
Other study ID # e4235
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received April 24, 2009
Last updated June 6, 2014
Start date November 2009
Est. completion date June 2011

Study information

Verified date June 2014
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Apremilast
oral dose of 30 mg BID for 6 months

Locations

Country Name City State
United States Oregon Health & Science University Portland Oregon

Sponsors (2)

Lead Sponsor Collaborator
Oregon Health and Science University Celgene Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye 6 months No
Primary Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50% 6 months No
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) 6 months No
Primary Reduction in Cystoid Macular Edema 6 months No
Secondary Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment 7 months Yes
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Active, not recruiting NCT05385757 - UNICORNS: Uveitis in Childhood Prospective National Cohort Study