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

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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.


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).
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LaFayette, Colorado 80026
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2147 Northeast Coachman Road
Clearwater, Florida 33765
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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610 3rd St # 206
Macon, Georgia 31201
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Orlando, Florida 32806
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Ann Arbor, Michigan 48109
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Clearwater, Florida 33756
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Clearwater, Florida 33756
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Gainesville, Florida 32608
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Gainesville, Florida 32610
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Gainesville, Florida 32610
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Kingswood, New South Wales 2747
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Mentor, Ohio 44060
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Naples, Florida 34102
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Norfolk, Virginia 23502
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Oceanside, California 92056
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Salt Lake City, Utah 84132
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Troy, Michigan 48098
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Troy, Michigan 48098
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Tyler, Texas 75701
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1720 South Beckham Avenue
Tyler, Texas 75701
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Wauwatosa, Wisconsin 53226
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Wauwatosa, Wisconsin 53226
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Willoughby, Ohio 44094
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