Apremilast in the Treatment of Uveitis

NCT ID: NCT00889421

Last Updated: 2014-07-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-06-30

Brief Summary

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

Detailed Description

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Conditions

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Uveitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Patients receiving apremilast.

Group Type EXPERIMENTAL

Apremilast

Intervention Type DRUG

oral dose of 30 mg BID for 6 months

Interventions

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Apremilast

oral dose of 30 mg BID for 6 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celgene Corporation

INDUSTRY

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Eric B. Suhler

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric B Suhler, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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e4235

Identifier Type: -

Identifier Source: org_study_id

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