Back to resultsAdalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis
Primary Purpose
Uveitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Uveitis
Eligibility Criteria
Inclusion Criteria:
- Patients with vision-threatening autoimmune uveitis.
- 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:
- Serious concomitant illness that could interfere with the subject's participation in the trial.
- Previous or current use of cyclophosphamide.
- Unable or unwilling to undergo multiple injections.
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Adalimumab
Arm Description
Outcomes
Primary Outcome Measures
Cumulative Endpoint
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00525902
First Posted
September 4, 2007
Last Updated
April 6, 2012
Sponsor
Oregon Health and Science University
Collaborators
University of Illinois at Chicago, The Cleveland Clinic
1. Study Identification
Unique Protocol Identification Number
NCT00525902
Brief Title
Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis
Official Title
An Open-label, Multicenter, Phase II Trial of Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
University of Illinois at Chicago, The Cleveland Clinic
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and efficacy of Adalimumab in uveitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adalimumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira
Intervention Description
40 mg delivered every 2 weeks by subcutaneous injection
Primary Outcome Measure Information:
Title
Cumulative Endpoint
Description
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.
Time Frame
10 weeks
Title
Cumulative Endpoint
Description
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.
Time Frame
50 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with vision-threatening autoimmune uveitis.
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:
Serious concomitant illness that could interfere with the subject's participation in the trial.
Previous or current use of cyclophosphamide.
Unable or unwilling to undergo multiple injections.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric B Suhler, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James T Rosenbaum, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Study Director
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis
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