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

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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.


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
Houston, Texas 77030
995
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Houston, TX
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
343
mi
from 43215
Baltimore, MD
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
2026
mi
from 43215
Portland, OR
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
1511
mi
from 43215
Salt Lake City, UT
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
432
mi
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Atlanta, GA
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9001 Wilshire Boulevard
Beverly Hills, California 90211
1979
mi
from 43215
Beverly Hills, CA
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1832 Avenida Córdoba
Buenos Aires, C1120
5385
mi
from 43215
Buenos Aires,
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303 East Superior Street
Chicago, Illinois 60611
274
mi
from 43215
Chicago, IL
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
277
mi
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Chicago, IL
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Dallas, Texas 75231
905
mi
from 43215
Dallas, TX
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Detroit, Michigan 48201
164
mi
from 43215
Detroit, MI
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
352
mi
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Durham, NC
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35 Eastward Lane
Ellsworth, Maine 04605
810
mi
from 43215
Ellsworth, ME
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Houston, Texas 77025
997
mi
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Houston, TX
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McAllen, Texas 78503
1291
mi
from 43215
McAllen, TX
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1 Medical Center Drive
Morgantown, West Virginia 26506
164
mi
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Morgantown, WV
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New York, New York
477
mi
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New York, NY
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
477
mi
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New York, NY
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Norfolk, Virginia 23502
426
mi
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Norfolk, VA
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Oklahoma City, Oklahoma 73104
849
mi
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Oklahoma City, OK
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540 Bergen Boulevard
Palisades Park, New Jersey 07650
479
mi
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Palisades Park, NJ
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San Antonio, Texas
1138
mi
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San Antonio, TX
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7401 North University Drive
Tamarac, Florida 33321
963
mi
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Tamarac, FL
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4506 Wishart Place
Tampa, Florida 33603
828
mi
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Tampa, FL
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Winston-Salem, North Carolina 27157
306
mi
from 43215
Winston-Salem, NC
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