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

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ClinicalTrials.gov Identifier: NCT00525902
Recruitment Status : Completed
First Posted : September 6, 2007
Results First Posted : April 9, 2012
Last Update Posted : April 11, 2012
Sponsor:
Collaborators:
University of Illinois at Chicago
The Cleveland Clinic
Information provided by (Responsible Party):
Eric B. Suhler, Oregon Health and Science University

Study Description
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Brief Summary:
The purpose of this study is to assess the safety and efficacy of Adalimumab in uveitis.

Condition or disease Intervention/treatment Phase
Uveitis Drug: Adalimumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Phase II Trial of Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis
Study Start Date : January 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Adalimumab Drug: Adalimumab
40 mg delivered every 2 weeks by subcutaneous injection
Other Name: Humira


Outcome Measures
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Primary Outcome Measures :
  1. Cumulative Endpoint [ Time Frame: 10 weeks ]
    Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography.

  2. Cumulative Endpoint [ Time Frame: 50 Weeks ]
    Improvement in at least one of these criteria without significant worsening in any of them. 1) improvement by 2 or more lines of best-corrected Snellen visual acuity in at least one eye; (2) reduction in dose of systemic corticosteroid or other immunosuppressive therapy by at least 50%; (3) two-step improvement in control of ocular inflammation; and (4) reduction of cystoid macular edema and other inflammatory signs on angiography.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525902


Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
University of Illinois at Chicago
The Cleveland Clinic
Investigators
Principal Investigator: Eric B Suhler, MD Oregon Health and Science University
Study Director: James T Rosenbaum, MD Oregon Health and Science University
More Information
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Responsible Party: Eric B. Suhler, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00525902     History of Changes
Other Study ID Numbers: e2434
First Posted: September 6, 2007    Key Record Dates
Results First Posted: April 9, 2012
Last Update Posted: April 11, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Uveitis
Uveal Diseases
Eye Diseases
 Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents