A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis

Part of paid clinical trials in Mobile, Alabama.

Sponsor
AbbVie
Study ID
NCT03653026
Phase
PHASE3
Status
Completed

Conditions

  • Ulcerative Colitis (UC)

Eligibility Criteria

Sex
ALL
Age
16 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Tablet for oral administration
  • Upadacitinib — DRUG
    Tablet for oral administration

Study Details

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis (UC).

Key Dates

Start date
Dec 6, 2018
Status verified
Feb 2022
Primary completion
Jan 14, 2021
Completion
Jan 14, 2021

Study Design

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

Arms

  • Experimental: Upadacitinib 45 mg
    Participants received 45 mg upadacitinib once daily (QD) for 8 weeks. Participants who did not achieve clinical response per Adapted Mayo score at Week 8 received upadacitinib 45 mg once daily for 8 additional weeks in the open-label extension period.
  • Placebo Comparator: Placebo
    Participants received placebo matching to upadacitinib once daily for 8 weeks. Participants who did not achieve clinical response per Adapted Mayo score at Week 8 received upadacitinib 45 mg once daily for 8 weeks in the open-label extension period.

Primary Outcome Measure

Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8 [ Time Frame: Week 8 ]

Locations (114)

FacilityCityStateZIPSite coordinators
CB Flock Research Corporation /ID# 206094MobileAlabama36608-
East View Medical Research, LLC /ID# 216933MobileAlabama36606-
Arizona Arthritis & Rheumatology Research, PLLC /ID# 211030Sun CityArizona85306-
Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211887TempeArizona85284-2604-
University of Arizona /ID# 208856TucsonArizona85724-
Citrus Valley Gastroenterology /ID# 205627CovinaCalifornia91722-3797-
Care Access Research /ID# 217003Huntington BeachCalifornia92648-5994-
Moore UC San Diego Cancer Center /ID# 204919La JollaCalifornia92093-
United Medical Doctors /ID# 207867Los AlamitosCalifornia90720-3309-
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 205314Los AngelesCalifornia90067-2001-
TLC Clinical Research Inc /ID# 216831Los AngelesCalifornia90048-
Facey Medical Foundation /ID# 205301Mission HillsCalifornia91345-
United Medical Doctors - Murrieta /ID# 205313MurrietaCalifornia92563-
InSite Digestive Health Care - Oxnard /ID# 205628OxnardCalifornia93030-
Inland Empire Clinical Trials, LLC /ID# 216164RialtoCalifornia92377-
Medical Assoc Research Grp /ID# 205626San DiegoCalifornia92123-
San Diego Clinical Trials /ID# 212122San DiegoCalifornia92120-
Delta Waves, Inc. /ID# 206170Colorado SpringsColorado80918-
Western States Clinical Res /ID# 206091Wheat RidgeColorado80033-2896-
Western Connecticut Medical Group /ID# 208290DanburyConnecticut06810-6000-
Gastroenterology Center of CT /ID# 208291HamdenConnecticut06518-
Gastro Florida /ID# 206174ClearwaterFlorida33756-
Universal Axon Clinical Research /ID# 213462DoralFlorida33166-
Palmetto Research, LLC /ID# 208293HialeahFlorida33016-
Nature Coast Clinical Research - Inverness /ID# 206087InvernessFlorida34452-4717-
Encore Borland-Groover Clinical Research /Id# 208128JacksonvilleFlorida32256-
Cfagi Llc /Id# 207995MaitlandFlorida32751-6108-
Coral Research Clinic /ID# 208292MiamiFlorida33186-4643-
University of Miami /ID# 215445MiamiFlorida33136-
Advanced Research Institute, Inc /ID# 206077New Port RicheyFlorida34653-
Endoscopic Research, Inc. /ID# 207360OrlandoFlorida32803-
Omega Research Consultants /ID# 206066OrlandoFlorida32810-
AdventHealth Tampa /ID# 207363TampaFlorida33613-4680-
Clinical Research Trials of Florida, Inc. /ID# 206068TampaFlorida33607-
University of South Florida /ID# 214495TampaFlorida33612-
Gastroenterology Associates of Central Georgia, LLC /ID# 216940MaconGeorgia31201-
Infinite Clinical Trials /ID# 215343RiverdaleGeorgia30274-
Atlanta Gastroenterology Spec /ID# 206173SuwaneeGeorgia30024-
Next Innovative Clinical Research - Chicago /ID# 217324ChicagoIllinois60605-2168-
The University of Chicago Medical Center /ID# 206172ChicagoIllinois60637-1443-
Carle Foundation Hospital /ID# 207397EffinghamIllinois62401-
MediSphere Medical Research Center /ID# 206073EvansvilleIndiana47714-8011-
Indianapolis Gastroenterology /ID# 206381IndianapolisIndiana46237-
University of Iowa Hospitals and Clinics /ID# 206167Iowa CityIowa52242-
Cotton-O'Neil Clinical Res Ctr /ID# 206175TopekaKansas66606-
Tri-State Gastroenterology /ID# 206124Crestview HillsKentucky41017-
Houma Digestive Health Special /ID# 206176HoumaLouisiana70360-
Louisana Research Center, LLC /ID# 206064ShreveportLouisiana71105-6800-
Gastro Center of Maryland /ID# 206883ColumbiaMaryland21045-
Huron Gastroenterology Assoc /ID# 205109Ann ArborMichigan48197-
University of Michigan Health Systems /ID# 206918Ann ArborMichigan48109-
Clin Res Inst of Michigan, LLC /ID# 207078ChesterfieldMichigan48047-
Revival Research Institute, LLC /ID# 207282SouthfieldMichigan48034-1659-
Center for Digestive Health /ID# 207080TroyMichigan48098-6363-
Mayo Clinic /ID# 205645RochesterMinnesota55905-0001-
Southern Therapy and Advanced Research (STAR) LLC /ID# 206069JacksonMississippi39216-
University of Mississippi Medical Center /ID# 213116JacksonMississippi39216-4500-
Las Vegas Medical Research /ID# 206814Las VegasNevada89113-
AGA Clinical Research Associates, LLC /ID# 206880Egg HarborNew Jersey08234-
Atlantic Digestive Health Inst /ID# 208748MorristownNew Jersey07960-
Rutgers Robert Wood Johnson /ID# 207382New BrunswickNew Jersey08901-
University of New Mexico Department of Internal Medicine /ID# 214397AlbuquerqueNew Mexico87131-0001-
NY Scientific /ID# 206080BrooklynNew York11235-
NYU Langone Long Island Clinical Research Associates /ID# 206079Lake SuccessNew York11042-
DiGiovanna Institute for Medical Education & Research /ID# 206885North MassapequaNew York11758-
Premier Medical Group - GI Division /ID# 206097PoughkeepsieNew York12601-
Gastro Group of Rochester /ID# 206881RochesterNew York14618-5703-
Richmond University Medical Center /ID# 213185Staten IslandNew York10310-1664-
Advantage Clinical Trials /ID# 206082The BronxNew York10468-
Digestive Health Partners, P.A /ID# 206842AshevilleNorth Carolina28801-
Atrium Health Carolinas Medical Center /ID# 206085CharlotteNorth Carolina28203-
Charlotte Gastroenterology and Hepatology, PLLC /ID# 206138CharlotteNorth Carolina28207-
Wake Forest Baptist Medical Center /ID# 206067Winston-SalemNorth Carolina27157-0001-
Duplicate_Plains Clinical Research Center, LLC /ID# 205111FargoNorth Dakota58104-
University of Cincinnati /ID# 205633CincinnatiOhio45267-0585-
Optimed Research, Ltd. /ID# 205638ColumbusOhio43235-
The Ohio State University /ID# 205637ColumbusOhio43210-
Hometown Urgent Care and Resea /ID# 205630DaytonOhio45424-
Dayton Gastroenterology, Inc. /ID# 205639EnglewoodOhio45415-
Great Lakes Gastroenterology Research LLC /ID# 205631MentorOhio44060-6211-
Digestive Disease Specialists /ID# 206076Oklahoma CityOklahoma73112-
Hightower Clinical /ID# 216336Oklahoma CityOklahoma73102-
Healthcare Research Consultant /ID# 206706TulsaOklahoma74135-
Options Health Research, LLC /ID# 206707TulsaOklahoma74104-
Guthrie Medical Group, PC /ID# 206078SayrePennsylvania18840-
Pharmacorp Clinical Trials /ID# 206074CharlestonSouth Carolina29412-
Gastroenterology Associates, P.A. of Greenville /ID# 206098GreenvilleSouth Carolina29615-3593-
Gastro One /ID# 206178GermantownTennessee38138-
East Tennessee Research Institute /ID# 206169Johnson CityTennessee37604-
Quality Medical Research /ID# 206088NashvilleTennessee37211-
Vanderbilt University Medical Center /ID# 210405NashvilleTennessee37232-0011-
TX Clinical Research Institute /ID# 206718ArlingtonTexas76012-
Inquest Clinical Research /ID# 206132BaytownTexas77521-
Texas Digestive Disease Consultants /ID# 209805Cedar ParkTexas78613-5028-
Texas Digestive Disease Consultants /ID# 209948Cedar ParkTexas78613-5028-
Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 207484DallasTexas75246-
DHAT Research Institute /ID# 206716GarlandTexas75044-2208-
Baylor College of Medicine - Baylor Medical Center /ID# 206717HoustonTexas77030-3411-
Centex Studies, Inc. - Houston /ID# 206168HoustonTexas77058-
GI Specialists of Houston /ID# 206090HoustonTexas77070-4347-
Vilo Research Group Inc /ID# 212625HoustonTexas77017-2337-
Caprock Gastro Research /ID# 215115LubbockTexas79424-3017-
Clinical Associates in Research Therapeutics of America, LLC /ID# 206710San AntonioTexas78212-
Southern Star Research Institute, LLC /ID# 205379San AntonioTexas78229-5390-
Baylor Scott & White Center for Diagnostic Medicine /ID# 206096TempleTexas76508-
Duplicate_Tyler Research Institue /ID# 206075TylerTexas75701-
Gastro Health & Nutrition - Victoria /ID# 205378VictoriaTexas77904-
Advanced Research Institute /ID# 206133OgdenUtah84403-
Ctr for Gastrointestinal Healt /ID# 208475FranklinVirginia23851-
Washington Gastroenterology Associates /ID# 206177BellevueWashington98004-
Virginia Mason - Seattle Orthapedics /ID# 206070SeattleWashington98101-
The Vancouver Clinic, INC. PS /ID# 204973VancouverWashington98664-
Froedtert Memorial Lutheran Hospital /ID# 206945MilwaukeeWisconsin53226-3522-
Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 206917MilwaukeeWisconsin53215-

Find similar trials in Mobile, AL

By research site
CB Flock Research Corporation· Mobile, ALEast View Medical Research, LLC· Mobile, ALArizona Arthritis & Rheumatology Research, PLLC· Sun City, AZDigestive Disease Consultants, A Division of Arizona Digestive Health, P.C· Tempe, AZUniversity of Arizona· Tucson, AZCitrus Valley Gastroenterology· Covina, CA

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