Apremilast in the Treatment of Uveitis

Uveitis Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00889421
• Other study ID #: e4235
• 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

• Uveitis

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