A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease
Status: | Completed |
---|---|
Conditions: | Gastrointestinal, Crohns Disease |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 76 |
Updated: | 10/18/2017 |
Start Date: | April 2012 |
End Date: | July 2016 |
A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease
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.
CP-690,550 therapy in subjects with Crohn's disease.
Inclusion Criteria:
- 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 Criteria:
- 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).
We found this trial at
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