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A Randomized Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease


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

Thank you

Trial Information

A Randomized Double-Blind, Placebo-Controlled, Parallel Group, Multi-Centre Study To Investigate The Safety And Efficacy Of CP-690,550 For Maintenance Therapy In Subjects With Moderate To Severe Crohn's Disease


Inclusion Criteria:



- Subjects who met study entry criteria, and who completed Week 8 visit of Induction
Study A3921083.

- Subjects who achieve clinical response-100 (reduction in CDAI by 100 points) and/or
clinical remission (CDAI<150) in Study A3921083.

- Women of childbearing potential must test negative for pregnancy prior to study
enrolment.

Exclusion Criteria:

- Subjects who had major protocol violation (as determined by the Sponsor) in the
A3921083 study.

- Subjects likely to require any type of surgery during the study period.

- Fecal culture/toxin assay indicating presence of pathogenic infection.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

The proportion of subjects maintaining clinical response-100, as defined by a decrease in CDAI score at least 100 points from A3921083 baseline, or being in clinical remission, as defined by a CDAI score less than 150, at Week 26.

Outcome Time Frame:

Week 26

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A3921084

NCT ID:

NCT01393899

Start Date:

March 2012

Completion Date:

April 2015

Related Keywords:

  • Crohn's Disease
  • Crohn Disease

Name

Location

University of Kentucky Chandler Medical CenterLexington, Kentucky  40536
Shands Hospital at the University of FloridaGainesville, Florida  32610
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
Surgical Centers of MichiganTroy, Michigan  48098
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
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