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 |
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.
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
sites
Ann Arbor, Michigan 48109
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Ann Arbor, Michigan 48109
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La Jolla, California 92037
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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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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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