Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis

NCT ID: NCT00525902

Last Updated: 2012-04-11

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-09-30

Brief Summary

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The purpose of this study is to assess the safety and efficacy of Adalimumab in 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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Adalimumab

Group Type EXPERIMENTAL

Adalimumab

Intervention Type DRUG

40 mg delivered every 2 weeks by subcutaneous injection

Interventions

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Adalimumab

40 mg delivered every 2 weeks by subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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Humira

Eligibility Criteria

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Inclusion Criteria

1. Patients with vision-threatening autoimmune uveitis.
2. Failure to respond to prednisone and at least one other systemic immunosuppressive (such as methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, cyclophosphamide, or chlorambucil), or intolerance to such medications due to side effects.

Exclusion Criteria

1. Serious concomitant illness that could interfere with the subject's participation in the trial.
2. Previous or current use of cyclophosphamide.
3. Unable or unwilling to undergo multiple injections.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Illinois at Chicago

OTHER

Sponsor Role collaborator

The Cleveland Clinic

OTHER

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Eric B. Suhler

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric B Suhler, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

James T Rosenbaum, MD

Role: STUDY_DIRECTOR

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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e2434

Identifier Type: -

Identifier Source: org_study_id

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