Status:
COMPLETED
A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease
Lead Sponsor:
Pfizer
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-76 years
Phase:
PHASE2
Brief Summary
The study hypothesis is to establish the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with Crohn's disease.
Eligibility Criteria
Inclusion
- Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects who withdraw early due to A3921084 study treatment failure (see Appendix 5).
- Women of childbearing potential must test negative for pregnancy prior to study enrolment.
- Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. No specific contraceptive measures are required in male subjects during study participation.
Exclusion
- Subjects who have been discontinued due to protocol violation(s) (as determined by the Sponsor) in the A3921084 study.
- Subjects who were discontinued from the A3921084 study due to an adverse event.
- Subjects likely to require any non-elective surgery or surgery requiring overnight stay (with the exception of minor same day outpatient procedures that will not interfere with study drug dosing).
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT01470599
Start Date
April 1 2012
End Date
July 1 2016
Last Update
October 16 2017
Active Locations (75)
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1
Alliance Clinical Research
Oceanside, California, United States, 92056
2
Clinical Research Of The Rockies
Lafayette, Colorado, United States, 80026
3
Gastroenterology Consultants of Clearwater
Clearwater, Florida, United States, 33756
4
West Coast Endoscopy Center
Clearwater, Florida, United States, 33756