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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)
Both
Crohn's Disease

Thank you

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
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).

Type of Study:

Interventional

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:

52 WEEKS

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A3921086

NCT ID:

NCT01470599

Start Date:

April 2012

Completion Date:

March 2016

Related Keywords:

  • Crohn's Disease
  • Crohn Disease

Name

Location

University of Kentucky Medical CenterLexington, Kentucky  40536-0093
University of Kentucky Chandler Medical CenterLexington, Kentucky  40536
Charlotte Gastroenterology & Hepatology, PllcCharlotte, North Carolina  28207
Center for Digestive HealthTroy, Michigan  48098
Digestive Health Specialists of TylerTyler, Texas  75701
Regional Gastroenterology Associates of Lancaster, Ltd.Lancaster, Pennsylvania  17604
Clinical Research Institute of Michigan, LLCChesterfield, Michigan  48047
Southwest GastroenterologyNew Lenox, Illinois  60451
Advanced Clinical Research Institute - Phase 1, LLCAnaheim, California  92801
AGMG Endoscopy CenterAnaheim, California  92801
Shands Endoscopy CenterGainesville, Florida  32608
Shands Medical Plaza and Cancer InstituteGainsville, Florida  32610
Gastroenterology Group of NaplesNaples, Florida  34102
Florida Medical Clinic, P.A.Zephyrhills, Florida  33542
Gastroenterology Associates of Central Georgia, LLCMacon, Georgia  31201
Utica Surgery CenterUtica, Michigan  48317
Premier Medical Group of the Hudson Valley, PCPoughkeepsie, New York  12601
Charlotte Gastroenterology and Hepatology, PLLCCharlotte, North Carolina  28207
Charlotte RadiologyCharlotte, North Carolina  28277
Dayton Gastroenterology, Inc.Dayton, Ohio  45415
Great Lakes GastroenterologyMentor, Ohio  44060
The Endoscopy Center of Lake CountyMentor, Ohio  44060
Endoscopy Center of TylerTyler, Texas  75701
University of Utah HSCSalt Lake City, Utah  84132
Wisconsin Center for Advanced Research - GI Associates, LLCMilwaukee, Wisconsin  53215
Investigational Drug ServiceGainesville, Florida  32610
Gastrointestinal and Liver SpecialistsNorfolk, Virginia  23502