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

Arm | Intervention/treatment |
---|---|
Experimental: Adalimumab |
Drug: Adalimumab
40 mg delivered every 2 weeks by subcutaneous injection
Other Name: Humira
|
- 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.
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
United States, Oregon | |
Oregon Health & Science University | |
Portland, Oregon, United States, 97239 |
Principal Investigator: | Eric B Suhler, MD | Oregon Health and Science University | |
Study Director: | James T Rosenbaum, MD | Oregon Health and Science University |
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 |