A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Pfizer
Study ID
NCT01465763
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tofacitinib — DRUG
    10 mg oral BID
  • Placebo — DRUG
    Plabebo oral BID

Study Details

This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.

Key Dates

Start date
Apr 30, 2012
Status verified
May 2016
Primary completion
May 31, 2015
Completion
May 31, 2015

Study Design

Enrollment
614 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: tofacitinib 10 mg BID
  • Placebo Comparator: Placebo

Primary Outcome Measure

Percentage of Participants With Remission at Week 8 [ Time Frame: Week 8 ]

Locations (71)

FacilityCityStateZIPSite coordinators
Internal Medicine Center, LLCMobileAlabama36608-
Springhill Memorial HospitalMobileAlabama36608-
Investigational Drug Service PharmacyLa JollaCalifornia92093-
UCSD Medical CenterLa JollaCalifornia92093-
UCSD Medical CentreLa JollaCalifornia92093-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Cedars Sinai Medical Center - Thalians BldgLos AngelesCalifornia90048-
Cedars Sinai Surgery CenterLos AngelesCalifornia90048-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
CRC Office - Cedars-Sinai Medical Center - Inflammatory Bowel Disease CenterLos AngelesCalifornia90048-
Desert Advanced ImagingPalm SpringsCalifornia92262-
Erik Palmer, DOPalm SpringsCalifornia92262-
Homan A Zadeh, MD, MPHPalm SpringsCalifornia92262-
Hope Square Surgical CenterRancho MirageCalifornia92270-
Sharp Rees-Stealy Medical GroupSan DiegoCalifornia92101-
Sharp Rees-Stealy Medical Group, Inc.San DiegoCalifornia92101-
Sharp Rees-Stealy Medical Group,IncSan DiegoCalifornia92123-
Endoscopy Center of Connecticut, LLCGuilfordConnecticut06437-
Endoscopy Center of Connecticut, LLCHamdenConnecticut06518-
Gastroenterology Center of Connecticut, PCHamdenConnecticut06518-
Medical Research Center of Connecticut, LLCHamdenConnecticut06518-
Florida Surgery CenterAltamonte SpringsFlorida32701-
Center for Advanced GastroenterologyMaitlandFlorida32751-
MNH Surgical CenterMaitlandFlorida32751-
Sand Lake ImagingMaitlandFlorida32751-
North Florida Gastroenterology Research, LLCOrange ParkFlorida32073-
Orange Park Surgery CenterOrange ParkFlorida32073-
Citrus Ambulatory Surgery CenterOrlandoFlorida32806-
Internal Medicine SpecialistsOrlandoFlorida32806-
Shafran Gastroenterology CenterWinter ParkFlorida32789-
Florida Medical Clinic, P.A.ZephyrhillsFlorida33542-
Georgia Endoscopy Center (Colonoscopy only)AlpharettaGeorgia30005-
GI Consultants (Colonoscopy only)AtlantaGeorgia30342-
Emory Healthcare Heart Center (EKG)Johns CreekGeorgia30097-
Gastroenterology Associates of Central GeorgiaMaconGeorgia31201-
Icahn School of Medicine at Mount SinaiMariettaGeorgia30067-
Atlanta Gastroenterology Specialists, PCSuwaneeGeorgia30024-
Johns Creek Diagnostic Center (X-Ray only)SuwaneeGeorgia30024-
Southwest GastroenterologyOak LawnIllinois60453-
East Ann Arbor Health and Geriatrics Center - University of Michigan Health SystemsAnn ArborMichigan48109-2701-
Medical Science Research Building 1 - University of Michigan Health SystemsAnn ArborMichigan48109-
Michigan Clinical Research Unit - Univeristy of Michigan Health SystemAnn ArborMichigan48109-5872-
Saint Joseph Mercy Hospital - Inpatient Pharmacy (Pharmacy Only)Ann ArborMichigan48106-
University of Michigan Health SystemsAnn ArborMichigan48109-5000-
Huron Gastroenterology Associates / Center for Digestive CareYpsilantiMichigan48197-
Michigan Heart SJMH (Blood draws and ECGs only)YpsilantiMichigan48106-
Saint Joseph Mercy Hospital Outpatient Laboratory (Blood draws only)YpsilantiMichigan48197-
Center for Advanced MedicineSt LouisMissouri63110-
Washington University School of Medicine - Division of GastroenterologySt LouisMissouri63110-
NYU Langone Long Island Clinical Research AssociatesGreat NeckNew York11021-
NYU Langone Nassau Gastroenterology AssociatesGreat NeckNew York11021-
Columbia University Medical CenterNew YorkNew York10032-
CUMC Research PharmacyNew YorkNew York10032-
Kornbluth, Legnani, George MD, PCNew YorkNew York10128-
Mount Sinai Doctos Faculty PracticeNew YorkNew York10029-
Mount Sinai Medical CenterNew YorkNew York10029-
Mount Sinai School of MedicineNew YorkNew York10029-
The Private Practice of Simon Lichtiger, MDNew YorkNew York10028-
Cleveland ClinicClevelandOhio44195-
Great Lakes GastroenterologyMentorOhio44060-
Mentor Medical CampusMentorOhio44060-
The Endoscopy Center of Lake CountyMentorOhio44060-
Baylor College of Medicine - Baylor Medical Center (Drug Storage)HoustonTexas77030-
Baylor College of Medicine (Baylor Medical Center)HoustonTexas77030-
Gastroenterology Consultants, P.A.HoustonTexas77034-
Houston Hospital for Specialized SurgeryHoustonTexas77004-
Alpine Medical GroupSalt Lake CityUtah84102-
Wasatch Clinical ResearchSalt Lake CityUtah84107-
Wasatch Endoscopy CenterSalt Lake CityUtah84124-
RGL Medical Services (x-ray only)West JordanUtah84084-
Wisconsin Center for Advanced Research - GI Associates, LLCMilwaukeeWisconsin53215-

Find similar trials in Mobile, AL

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Internal Medicine Center, LLC· Mobile, ALSpringhill Memorial Hospital· Mobile, ALInvestigational Drug Service Pharmacy· La Jolla, CAUCSD Medical Center· La Jolla, CAUCSD Medical Centre· La Jolla, CACedars Sinai Medical Center· Los Angeles, CA

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