A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis



Status:Completed
Conditions:Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:8/13/2016
Start Date:July 2012
End Date:May 2016

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A Multicentre, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Of Oral CP-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis

The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and
tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes
to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively
achieves mucosal healing and improves quality of life in subjects with UC.The study proposes
to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over
the age of 18 years with UC.


Inclusion Criteria:

- Subjects who met study entry criteria and completed 8-week induction treatment from
Study A3921094 or A3921095

- Subjects who achieved clinical response in Study A3921094 or A3921095

- Women of childbearing potential must test negative for pregnancy prior to study
enrollment

- Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures

- Evidence of a personally signed and dated informed consent document(s) indicating
that the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the study.

Exclusion Criteria:

- Subjects who had major protocol violation (as determined by the Sponsor) in Study
A3921094 or A3921095

- Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious
colitis, or clinical findings suggestive of Crohn's disease

- Subjects who have had surgery for UC or in the opinion of the investigator, are
likely to require surgery for UC during the study period.
We found this trial at
94
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Salt Lake City, Utah 84102
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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610 3rd St # 206
Macon, Georgia 31201
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Orlando, Florida 32806
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1690 Dunlawton Ave # 220
Port Orange, Florida 32127
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Alpharetta, Georgia 30005
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Ann Arbor, Michigan 48109
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Atlanta, Georgia 30342
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Austin, Texas 78745
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Baltimore, Maryland 21229
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Bristol, Connecticut 06010
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Catonsville, Maryland 21228
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Chesterfield, Michigan 48098
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Columbia, Maryland 21044
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Concord, New South Wales
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Egg Harbour Township, New Jersey 08234
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Greenville, North Carolina 27834
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Guilford, Connecticut 06437
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Hamden, Connecticut 06518
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Hamden, Connecticut 06518
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Inverness, Florida 34452
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Inverness, Florida 34453
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Johns Creek, Georgia 30097
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La Jolla, California 92093
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Marlton, New Jersey 08053
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Mentor, Ohio 44060
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Milwaukee, Wisconsin 53215
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Mobile, Alabama 36608
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
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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...
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New York, New York 10128
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Oceanside, California 92056
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Orange Park, Florida 32073
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Palm Springs, California 92262
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Port Orange, Florida 32127
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Richmond, Virginia 23298
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Richmond, Virginia 23298
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Rochester, Minnesota 55905
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Salt Lake City, Utah 84107
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Salt Lake City, Utah 84124
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San Diego, California 92101
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San Diego, California 92103
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Suwanee, Georgia 30024
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Ypsilanti, Michigan 48197
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Zephyhills, Florida 33542
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