A Open-Label Study Of CP-690,550 As Long-Term Therapy (48 Weeks) In Subjects With Crohn's Disease

Completed · Phase 2

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT01470599

Run by

Pfizer

People needed

150

Starts

2012-04-01

Expected to finish

2016-07-01

Last updated by the study team

2017-10-16

Who can join

Age: 18 and older, up to 76. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Clinical Research Of The Rockies — Lafayette, Colorado, United States
• Gastroenterology Consultants of Clearwater — Clearwater, Florida, United States
• West Coast Endoscopy Center — Clearwater, Florida, United States
• Clinical Research of West Florida, Inc. — Clearwater, Florida, United States
• Shands Endoscopy Center — Gainesville, Florida, United States
• Shands Hospital at the University of Florida — Gainesville, Florida, United States
• Investigational Drug Service — Gainesville, Florida, United States
• Shands Medical Plaza and Cancer Center — Gainesville, Florida, United States
• Gastroenterology Group of Naples — Naples, Florida, United States
• Gulfshore Endoscopy Center (Endoscopies Only) — Naples, Florida, United States
• North Florida Gastroenterology Research, LLC — Orange Park, Florida, United States
• Internal Medicine Specialists — Orlando, Florida, United States
• Gastroenterology Associates of Central Georgia, LLC — Macon, Georgia, United States
• East Ann Arbor Health and Geriatrics Center — Ann Arbor, Michigan, United States
• University of Michigan Health Systems — Ann Arbor, Michigan, United States
• Center for Digestive Health — Troy, Michigan, United States
• Surgical Centers of Michigan — Troy, Michigan, United States
• NYU Langone Long Island Clinical Research Associates — Great Neck, New York, United States
• NYU Langone Nassau Gastroenterology Associates — Great Neck, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Great Lakes Gastroenterology — Mentor, Ohio, United States
• The Endoscopy Center of Lake County — Mentor, Ohio, United States
• Great Lakes Gastroenterology — Willoughby, Ohio, United States
• Christus Trinity Mother Frances Endoscopy Center — Tyler, Texas, United States
• Alliance Clinical Research — Oceanside, California, United States

Full record on ClinicalTrials.gov

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