Apremilast in the Treatment of Uveitis

Phase 2TerminatedNCT00889421

Oregon Health and Science University3 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Uveitis

Interventions

ApremilastDRUG

oral dose of 30 mg BID for 6 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye

Time frame: 6 months

Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%

Time frame: 6 months

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

Reduction in Cystoid Macular Edema

Time frame: 6 months

Secondary Outcomes

Type, Frequency, Severity, and Relationship of Adverse Events to Study Treatment

Time frame: 7 months

Data from ClinicalTrials.gov

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