An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Takeda
Study ID
NCT02497469
Phase
PHASE3
Status
Completed

Conditions

  • Colitis, Ulcerative

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Vedolizumab — DRUG
    Vedolizumab infusion
  • Adalimumab placebo — DRUG
    Adalimumab placebo-matching injection
  • Adalimumab — DRUG
    Adalimumab injection
  • Vedolizumab placebo — DRUG
    Vedolizumab placebo-matching infusion

Study Details

The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.

Key Dates

Start date
Jun 29, 2015
Status verified
Jan 2020
Primary completion
Sep 26, 2018
Completion
Jan 18, 2019

Study Design

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

Arms

  • Experimental: Vedolizumab IV 300 mg
    Vedolizumab 300 milligram (mg), infusion, intravenously over 30 minutes on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46. Adalimumab placebo-matching injection, subcutaneously on Day 1, Week 2, and every 2 weeks thereafter up to Week 50.
  • Active Comparator: Adalimumab SC 160/80/40 mg
    Adalimumab 160 mg, injection, subcutaneously on Day 1, adalimumab 80 mg, injection, subcutaneously at Week 2, then adalimumab 40 mg, injection, subcutaneously every 2 weeks thereafter up to Week 50. Vedolizumab placebo-matching infusion, intravenously on Day 1 and Weeks 2, 6, 14, 22, 30, 38, and 46.

Primary Outcome Measure

Percentage of Participants Who Achieved Clinical Remission [ Time Frame: Week 52 ]

Locations (77)

FacilityCityStateZIPSite coordinators
IMC - Diagnostic and Medical ClinicMobileAlabama36604-
Arizona Arthritis & Rheumatology Research, PLLCPhoenixArizona85037-
Arkansas Primary Care Clinic, PALittle RockArkansas72204-
WCCT Global (PH 1 Unit)Costa MesaCalifornia92626-
California Medical Research Associates Inc.NorthridgeCalifornia91324-
Sutter Institute for Medical ResearchSacramentoCalifornia95816-
Rocky Mountain GastroenterologyLakewoodColorado80214-5434-
Medical Research Center of Connecticut, LLCHamdenConnecticut06518-
Innovative Medical Research of South Florida, Inc.AventuraFlorida33180-
Advanced Clinical Research of MiamiDoralFlorida33172-
Wellness Clinical ResearchHialeah GardensFlorida33016-
Nature Coast Clinical Research, LLCInvernessFlorida34452-
Florida Center for GastroenterologyLargoFlorida33773-1615-
Gastro HealthMiamiFlorida33143-
Medical Professional Clinical ResearchMiamiFlorida33165-
Tellus Clinical Research, Inc.MiamiFlorida33173-
South Florida Research Phase I-IVMiami SpringsFlorida33166-
Gastroenterology Group of NaplesNaplesFlorida34102-
Internal Medicine SpecialistsOrlandoFlorida32806-
BRCR Medical Center, Inc.PlantationFlorida33322-
Clinical Research Center of FloridaPompano BeachFlorida33060-
Shafran Gastroenterology CenterWinter ParkFlorida32789-
Emory University HospitalAtlantaGeorgia30322-
Gastroenterology Associates of Central GeorgiaMaconGeorgia31201-
Northwestern University Feinberg School of MedicineChicagoIllinois60611-
Rush University Medical CenterChicagoIllinois60612-
Carle Foundation HospitalUrbanaIllinois61801-
Gastroenterology of Southern AssociatesNew AlbanyIndiana47150-
Iowa Digestive Disease CenterCliveIowa50325-
Cotton-O'Neil Clinical Research Center, Digestive HealthTopekaKansas66606-
University of LouisvilleLouisvilleKentucky40202-
Research Concierge, LLCOwensboroKentucky42303-
Gastroenterology Associates, LLCBaton RougeLouisiana70809-
Lafayette General Medical CenterLafayetteLouisiana70503-
Clinical Trials Management, LLCMetairieLouisiana70006-
Louisiana Research Center, LLCShreveportLouisiana71103-
Digestive Disease AssociatesCatonsvilleMaryland21228-
Chevy Chase Clinical ResearchChevy ChaseMaryland20815-
Clinical Research Institute of Michigan, LLCChesterfieldMichigan48047-
Center for Digestive Health and Nutritional ExcellenceTroyMichigan48098-
Gastroenterology Associates of Western Michigan, P.L.C.WyomingMichigan49519-
Mayo Clinic - RochesterRochesterMinnesota55905-
Digestive Health Center PAOcean SpringsMississippi39564-
Ehrhardt Clinical Research, LLCBeltonMissouri64012-
Truman Medical Centers, Inc.Kansas CityMissouri64108-
Alegent Creighton Clinic GastroenterologyOmahaNebraska68124-
AGA Clinical Research Associates, LLCEgg HarborNew Jersey08234-
Long Island Clinical Research AssociatesGreat NeckNew York11021-
Mount Sinai - PRIMELake SuccessNew York10029-
Digestive Disease CareNew Hyde ParkNew York11040-
Premier Medical Group of the Hudson Valley, PCPoughkeepsieNew York12601-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-7080-
Consultants for Clinical Research Inc.CincinnatiOhio45219-
Ohio State University Clinical Trials Management OfficeColumbusOhio43210-
Dayton Gastroenterology, IncDaytonOhio45415-
Gastro-Enterology Research of LimaLimaOhio45806-
Options Health ResearchTulsaOklahoma74104-
The Oregon Clinic-West Hills GastroenterologyPortlandOregon97225-
Main Line Gastroenterology AssociatesMalvernPennsylvania19355-
Medical University of South Carolina (MUSC)CharlestonSouth Carolina29425-
Invocare Clinical Research CenterWest ColumbiaSouth Carolina29169-
Vanderbilt University Medical CenterNashvilleTennessee37212-1375-
Baylor University HospitalDallasTexas75246-
Texas Digestive Disease Consultants - DallasDallasTexas75231-
MedResearch, IncEl PasoTexas79935-
Gastroenterology Consultants of South Texas, PAHarlingenTexas78550-
Gulf Coast Research Group LLCHoustonTexas77098-
Texas Digestive Disease Consultants - IrvingIrvingTexas75039-
Advanced Clinical Research AssociatesPlanoTexas75093-
Gastroenterology Research of San Antonio, LLCSan AntonioTexas78229-
Texas Digestive Disease Consultants - SouthlakeSouthlakeTexas76092-
Digestive Health Specialists of TylerTylerTexas75701-
Gastroenterology Associates of TidewaterChesapeakeVirginia23320-
Virginia Mason Seattle Main ClinicSeattleWashington98101-
Wenatchee Valley Hospital & ClinicsWenatcheeWashington98801-
University of WisconsinMadisonWisconsin53705-
Allegiance Research Specialists, LLCMilwaukeeWisconsin53226-

Find similar trials in Mobile, AL

By research site
IMC - Diagnostic and Medical Clinic· Mobile, ALArizona Arthritis & Rheumatology Research, PLLC· Phoenix, AZArkansas Primary Care Clinic, PA· Little Rock, ARWCCT Global (PH 1 Unit)· Costa Mesa, CACalifornia Medical Research Associates Inc.· Northridge, CASutter Institute for Medical Research· Sacramento, CA

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