Status:
COMPLETED
A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis
Lead Sponsor:
Pfizer
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 whethe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 20 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 27 2016
Estimated Enrollment :
593 Patients enrolled
Trial Details
Trial ID
NCT01458574
Start Date
July 20 2012
End Date
May 27 2016
Last Update
May 18 2017
Active Locations (275)
Enter a location and click search to find clinical trials sorted by distance.
1
Internal Medicine Center, LLC
Mobile, Alabama, United States, 36608
2
Springhill Memorial Hospital (Endoscopy Only)
Mobile, Alabama, United States, 36608
3
UCSD Health System - Investigational Drug Pharmacy - Moores Cancer Center
La Jolla, California, United States, 92037-0845
4
UCSD Medical Center
La Jolla, California, United States, 92093