A Study of the Long-term Safety and Efficacy of Adalimumab in Subjects With Intermediate-, Posterior-, or Pan-uveitis
Status: | Completed |
---|---|
Conditions: | Cervical Cancer, Ocular |
Therapuetic Areas: | Oncology, Ophthalmology |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 4/17/2018 |
Start Date: | November 23, 2010 |
End Date: | March 15, 2018 |
A Multicenter Open-Label Study of the Long-term Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Non-infectious Intermediate-, Posterior-, or Pan-uveitis
There is an unmet medical need in non-infectious intermediate-, posterior- and pan uveitis.
These types of uveitis are at a higher risk for vision loss compared to anterior uveitis.
Patients with these types of uveitis are often treated with chronic corticosteroids. The use
of chronic corticosteroids is linked with predictable long-term side effects. The objective
of this study is to evaluate the long term efficacy and safety of adalimumab subjects with
non-infectious intermediate-, posterior- or pan-uveitis.
These types of uveitis are at a higher risk for vision loss compared to anterior uveitis.
Patients with these types of uveitis are often treated with chronic corticosteroids. The use
of chronic corticosteroids is linked with predictable long-term side effects. The objective
of this study is to evaluate the long term efficacy and safety of adalimumab subjects with
non-infectious intermediate-, posterior- or pan-uveitis.
Inclusion Criteria:
- Subject must have successfully enrolled in either study M10-877 or M10-880 and either
met the endpoint of "Treatment Failure" or completed the study
Exclusion Criteria:
- A subject will be excluded from this study if the patient discontinued from study
M10-877 or M10-880 for any reasons other than having a Treatment Failure event
- Subject with corneal or lens opacity that precludes visualization of the fundus or
that likely requires cataract surgery during the duration of the trial
- Subjects with intraocular pressure of >= 25 mmHg and on >= 2 glaucoma medications or
evidence of glaucomatous optic nerve injury
- Subject with proliferative or severe non-proliferative diabetic retinopathy or
clinically significant macular edema due to diabetic retinopathy
- Subject with neovascular/wet age-related macular degeneration
- Subject with abnormality of vitreo-retinal interface (i.e., vitreomacular traction,
epiretinal membranes, etc.) with the potential for macular structural damage
independent of the inflammatory process
- Subject with a systemic inflammatory disease that requires therapy with a prohibited
immunosuppressive agent at the time of study entry
We found this trial at
25
sites
Emory University Hospital As the largest health care system in Georgia and the only health...
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Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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University of Utah Research is a major component in the life of the U benefiting...
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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