Adalimumab (Humira) in the Treatment of Refractory Non-infectious Uveitis
This study has been completed.
Sponsor:
Oregon Health and Science University
Collaborators:
University of Illinois at Chicago
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
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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:
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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525902
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 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
| 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 Uveal Diseases Eye Diseases |
Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on September 30, 2016