A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Pfizer
Study ID
NCT01458951
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
    Placebo 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
Jun 30, 2012
Status verified
Apr 2016
Primary completion
May 31, 2015
Completion
Jun 30, 2015

Study Design

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

Arms

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

Primary Outcome Measure

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

Locations (62)

FacilityCityStateZIPSite coordinators
Desert Sun Clinical Research, LLCTucsonArizona85710-
Desert Sun GastroenterologyTucsonArizona85710-
Desert Sun Surgery CenterTucsonArizona85710-
Alliance Clinical ResearchOceansideCalifornia92056-
Clinical Application LaboratoriesSan DiegoCalifornia92103-
San Diego Endoscopy CenterSan DiegoCalifornia92103-
UCSF Endoscopy Unit at Mount ZionSan FranciscoCalifornia94115-
University of California San FranciscoSan FranciscoCalifornia94115-
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical CenterTorranceCalifornia90502-
Bristol HospitalBristolConnecticut06010-
Connecticut Clinical Research FoundationBristolConnecticut06010-
Yale New Haven HospitalNew HavenConnecticut06510-
Yale University School of MedicineNew HavenConnecticut06510-
Central Connecticut Endoscopy CenterPlainvilleConnecticut06062-
Citrus Surgery & Endoscopy Center (Colonoscopy)Crystal RiverFlorida34429-
Nature Coast Clinical ResearchInvernessFlorida34452-
Suncoast Endoscopy Center (colonoscopy)InvernessFlorida34453-
Gastroenterology Group of NaplesNaplesFlorida34102-
Advanced Gastroenterology CenterPort OrangeFlorida32127-
Advanced Medical Research CenterPort OrangeFlorida32127-
Endoscopy CenterPort OrangeFlorida32127-
Port Orange Urgent CarePort OrangeFlorida32127-
Atlanta Center for Gastroenterology, P.C.DecaturGeorgia30033-
Cotton-O'Neil Clinical Research Center, Digestive HealthTopekaKansas66606-
Gastrointestinal Specialists, A.M.C.ShreveportLouisiana71103-
Louisiana Research Center, LLCShreveportLouisiana71105-
Shreveport Endoscopy Center, A.M.C.ShreveportLouisiana71103-
Chevy Chase Endoscopy Center (Endoscopies Only)Chevy ChaseMaryland20815-
MGG Group Co., Inc., Chevy Chase Clinical ResearchChevy ChaseMaryland20815-
Clinical Research Institute of Michigan, LLCChesterfieldMichigan48047-
Center for Digestive HealthTroyMichigan48098-
Surgical Centers of MichiganTroyMichigan48098-
Mayo ClinicRochesterMinnesota55905-
Surgery Center of ColumbiaColumbiaMissouri65201-
Hannibal Regional HospitalHannibalMissouri63401-
Audrain Medical CenterMexicoMissouri65265-
Center for Digestive & Liver Disease, Inc.MexicoMissouri65265-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
AGA Clinical Research Associates, LLCEgg HarborNew Jersey08234-
South Jersey GastroenterologyMarltonNew Jersey08053-
The Gastroenterology Group of South JerseyVinelandNew Jersey08360-
The Endo Center at VoorheesVoorhees TownshipNew Jersey08043-
University of RochesterRochesterNew York14642-
Carolina Research - Carolina Digestive DiseasesGreenvilleNorth Carolina27834-
Regional Gastroenterology Associates of Lancaster, Ltd.LancasterPennsylvania17604-
Vanderbilt University Medical Center - Drug ShipmentNashvilleTennessee37232-7610-
Vanderbilt University Medical Center - GCRCNashvilleTennessee37232-
Vanderbilt University Medical Center - GI Research OfficeNashvilleTennessee37212-1610-
Vanderbilt University Medical Center - Heart StationNashvilleTennessee37232-
Vanderbilt University Medical Center - IBD ClinicNashvilleTennessee37212-1375-
Vanderbilt University Medical Center - RadiologyNashvilleTennessee37232-
Texas Clinical Research InstitiuteArlingtonTexas76012-
Austin Endoscopy Center IIAustinTexas78746-
Austin Gastroenterology PAAustinTexas78745-
Austin Gastroenterology PA/Professional Quality Research, Inc.AustinTexas78705-
Memorial Hermann HospitalHoustonTexas77030-
The University of Texas Health Science Center at HoustonHoustonTexas77030-
Digestive Health Specialists of TylerTylerTexas75701-
VCU Health System Digestive Health CenterRichmondVirginia23298-
VCU Health System Endoscopy SuiteRichmondVirginia23298-
VCU Medical Center Investigational Drug Service (IDS)RichmondVirginia23298-
Virginia Commonwealth University, Clinical Research Services (CRSU)RichmondVirginia23298-

Find similar trials in Tucson, AZ

By condition
Ulcerative colitis
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Desert Sun Clinical Research, LLC· Tucson, AZDesert Sun Gastroenterology· Tucson, AZDesert Sun Surgery Center· Tucson, AZAlliance Clinical Research· Oceanside, CAClinical Application Laboratories· San Diego, CASan Diego Endoscopy Center· San Diego, CA

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