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

This study has been completed.
Sponsor:
Collaborators:
University of Illinois
The Cleveland Clinic
Information provided by (Responsible Party):
Eric B. Suhler, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00525902
First received: September 4, 2007
Last updated: April 6, 2012
Last verified: April 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Uveitis
 Drug: Adalimumab
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Cumulative Endpoint [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
    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.

  • Cumulative Endpoint [ Time Frame: 50 Weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 31
Study Start Date: January 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adalimumab Drug: Adalimumab
40 mg delivered every 2 weeks by subcutaneous injection
Other Name: Humira

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
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

No publications provided

Responsible Party: Eric B. Suhler, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00525902     History of Changes
Other Study ID Numbers: e2434
Study First Received: September 4, 2007
Results First Received: February 3, 2012
Last Updated: April 6, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
 Uveitis, Posterior
Panuveitis
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013