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A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients With Crohn's Disease

Phase 2
18 Years
75 Years
Open (Enrolling)
Crohn's Disease

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Trial Information

A Open-Label Extension Study Of CP-690,550 As Maintenance Therapy In Patients 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

- 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).

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence and severity of adverse events

Outcome Time Frame:


Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

April 2012

Completion Date:

March 2016

Related Keywords:

  • Crohn's Disease
  • Crohn Disease



University of Kentucky Medical Center Lexington, Kentucky  40536-0093
University of Kentucky Chandler Medical Center Lexington, Kentucky  40536
Charlotte Gastroenterology & Hepatology, Pllc Charlotte, North Carolina  28207
Center for Digestive Health Troy, Michigan  48098
Digestive Health Specialists of Tyler Tyler, Texas  75701
Regional Gastroenterology Associates of Lancaster, Ltd. Lancaster, Pennsylvania  17604
Clinical Research Institute of Michigan, LLC Chesterfield, Michigan  48047
Southwest Gastroenterology New Lenox, Illinois  60451
Advanced Clinical Research Institute - Phase 1, LLC Anaheim, California  92801
AGMG Endoscopy Center Anaheim, California  92801
Shands Endoscopy Center Gainesville, Florida  32608
Shands Medical Plaza and Cancer Institute Gainsville, Florida  32610
Gastroenterology Group of Naples Naples, Florida  34102
Florida Medical Clinic, P.A. Zephyrhills, Florida  33542
Gastroenterology Associates of Central Georgia, LLC Macon, Georgia  31201
Utica Surgery Center Utica, Michigan  48317
Premier Medical Group of the Hudson Valley, PC Poughkeepsie, New York  12601
Charlotte Gastroenterology and Hepatology, PLLC Charlotte, North Carolina  28207
Charlotte Radiology Charlotte, North Carolina  28277
Dayton Gastroenterology, Inc. Dayton, Ohio  45415
Great Lakes Gastroenterology Mentor, Ohio  44060
The Endoscopy Center of Lake County Mentor, Ohio  44060
Endoscopy Center of Tyler Tyler, Texas  75701
University of Utah HSC Salt Lake City, Utah  84132
Wisconsin Center for Advanced Research - GI Associates, LLC Milwaukee, Wisconsin  53215
Investigational Drug Service Gainesville, Florida  32610
Gastrointestinal and Liver Specialists Norfolk, Virginia  23502