The Safety And Efficacy Of Maintenance Therapy With CP-690,550



Status:Completed
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:March 2012
End Date:July 2015

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Trial Summary
Trial Overview
Inclusion Criteria

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

This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to
severe Crohn's disease who completed the double-blind induction treatment in Study A3921083
and achieved clinical response-100 and/or clinical remission (CDAI<150) at Week 8.


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.
We found this trial at
41
sites
Clinical Research of West Florida
2147 Northeast Coachman Road
Clearwater, Florida 33765
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Cleveland Clinic
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Shands Hospital at the University of Florida
Gainesville, Florida 32610
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Gainesville, FL
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Gastroenterology Associates of Central Georgia
610 3rd St # 206
Macon, Georgia 31201
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Macon, GA
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Internal Medicine Specialists
Orlando, Florida 32806
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Orlando, FL
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ACMG Endoscopy Center
Anaheim, California 92801
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Anaheim, CA
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ACRI - Phase I
Anaheim, California 92801
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Anaheim, CA
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Advanced Clinical Research Institute - Phase 1, LLC
Anaheim, California 92801
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Anaheim, CA
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University of Michigan Health Systems
Ann Arbor, Michigan 48109
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Ann Arbor, MI
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Chevy Chase Endoscopy Center
Chevy Chase, Maryland 20815
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Chevy Chase, MD
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Metropolitan Gastroenterology Group, P.C.
Chevy Chase, Maryland 20815
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Chevy Chase, MD
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Gasteroenterology Consultants of Clearwater
Clearwater, Florida 33756
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Clearwater, FL
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West Coast Endoscopy Center
Clearwater, Florida 33756
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Clearwater, FL
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Investigational Drug Services - University Hospitals Case Medical Center
Cleveland, Ohio 44106
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Cleveland, OH
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University Hospitals at Case Medical Center
Cleveland, Ohio 44194
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Cleveland, OH
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West Coast Clinical Trials, LLC
Cypress, California 90630
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Cypress, CA
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Shands Endoscopy Center
Gainesville, Florida 32608
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Gainesville, FL
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Shands Medical Plaza and Cancer Center
Gainesville, Florida 32610
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Gainesville, FL
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University of Florida - College of Medicine
3450 Hull Road
Gainsville, Florida 32610
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Gainsville, FL
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Nyu Langone Long Island Clinical Research Associates
Great Neck, New York 11021
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Great Neck, NY
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Nepean Public Hospital
Kingswood, New South Wales 2747
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Kingswood,
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Clinical Research of the Rockies
LaFayette, Colorado 80026
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LaFayette, CO
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Great Lakes Gastroenterology
Mentor, Ohio 44060
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Mentor, OH
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Center for Digestive Health
Milwaukee, Wisconsin 53215
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Milwaukee, WI
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Wisconsin Center for Advanced Research - GI Associates, LLC
Milwaukee, Wisconsin 53215
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Milwaukee, WI
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Gastroenterology Group of Naples
Naples, Florida 34102
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Naples, FL
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Gulfshore Endoscopy Center (Endoscopies Only)
Naples, Florida 34102
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Naples, FL
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Cardiology Consultants
Norfolk, Virginia 23502
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Norfolk, VA
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Digestive & Liver Desease Specialists
Norfolk, Virginia 23502
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Norfolk, VA
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Alliance Clinical Research
Oceanside, California 92056
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Oceanside, CA
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North Florida Gastroenterology Research, LLC
Orange Park, Florida 32073
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Orange Park, FL
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Premier Medical Group of the Hudson Valley
243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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University of Utah HSC
Salt Lake City, Utah 84132
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Salt Lake City, UT
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Cotton-O'Neil Clinical Research Center, Digestive Health
Topeka, Kansas 66606
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Topeka, KS
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Center for Digestive Health
Troy, Michigan 48098
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Troy, MI
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Surgical Centers of Michigan
Troy, Michigan 48098
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Troy, MI
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Digestive Health Specialists of Tyler
Tyler, Texas 75701
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Tyler, TX
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Endoscopy Center of Tyler
Tyler, Texas 75701
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Tyler, TX
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Metropolitan Gastroenterology Group, P C
Washington DC, Virginia 20006
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Washington DC, VA
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Allegiance Research Specialists
Wauwatosa, Wisconsin 53226
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Wauwatosa, WI
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GI Associates
Wauwatosa, Wisconsin 53226
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Wauwatosa, WI
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