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
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Baltimore, Maryland 21229
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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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Cleveland, OH
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610 3rd St # 206
Macon, Georgia 31201
1974
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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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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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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
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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
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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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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New York, New York 10029
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New York, New York 10032
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Oceanside, California 92056
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Orlando, Florida 32806
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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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Rochester, Minnesota 55905
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Salt Lake City, Utah 84102
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Salt Lake City, Utah 84107
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San Diego, California 92101
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Ypsilanti, Michigan 48197
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Zephyhills, Florida 33542
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Zephyrhills, Florida 33542
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