A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)

Part of paid clinical trials in Mobile, Alabama.

Sponsor
AbbVie
Study ID
NCT03006068
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Ulcerative Colitis (UC)

Eligibility Criteria

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

Interventions

  • Upadacitinib (ABT-494) — DRUG
    Upadacitinib (ABT-494) will be administered orally.
  • Placebo — DRUG
    Placebo will be administered orally.

Study Details

This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.

Key Dates

Start date
Jan 31, 2017
Status verified
Jan 2026
Primary completion
Jul 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
950 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants receiving Upadacitinib (ABT-494) Dose A
    The participants in this arm will receive Upadacitinib (ABT-494) dose A.
  • Experimental: Participants receiving Upadacitinib (ABT-494) Dose B
    The participants in this arm will receive Upadacitinib (ABT-494) dose B.
  • Experimental: Participants receiving Upadacitinib (ABT-494) Dose A or Dose B
    The participants in this arm will receive Upadacitinib (ABT-494) dose A or dose B.
  • Experimental: Participants receiving Placebo
    The participants in this arm will receive placebo until study is unblinded.
  • Experimental: Participants receiving Upadacitinib (ABT-494) Dose C
    The participants in this arm will receive Upadacitinib (ABT-494) dose C.

Primary Outcome Measure

Assessing Treatment-Emergent Adverse Events [ Time Frame: Up to 288 Weeks ]

Locations (147)

FacilityCityStateZIPSite coordinators
CB Flock Research Corporation /ID# 165986MobileAlabama36608-
East View Medical Research, LLC /ID# 171184MobileAlabama36606-
Delsol Research Management, Ll /Id# 170130ChandlerArizona85224-
Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211886MesaArizona85206-
Duplicate_Arizona Arthritis & Rheumatology Research, PLLC /ID# 169823Sun CityArizona85306-
Adobe Clinical Research LLC /ID# 155249TucsonArizona85712-
Duplicate_University of Arizona /ID# 150568TucsonArizona85724-
Citrus Valley Gastroenterology /ID# 151915CovinaCalifornia91722-3797-
Newport Huntington Medical Group /ID# 217006Huntington BeachCalifornia92648-5994-
UC San Diego Health System /ID# 155187La JollaCalifornia92037-
United Medical Doctors /ID# 207467Los AlamitosCalifornia90720-3309-
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 157082Los AngelesCalifornia90067-2001-
TLC Clinical Research Inc /ID# 216830Los AngelesCalifornia90048-
Facey Medical Foundation /ID# 203135Mission HillsCalifornia91345-
United Medical Doctors - Murrieta /ID# 151213MurrietaCalifornia92563-
Ventura County Gastroenterology Medical Group /ID# 163417OxnardCalifornia93030-0190-
Inland Empire Clinical Trials, LLC /ID# 216163RialtoCalifornia92377-
Medical Assoc Research Grp /ID# 169149San DiegoCalifornia92123-
San Diego Clinical Trials /ID# 212121San DiegoCalifornia92120-
Univ of California San Francis /ID# 164583San FranciscoCalifornia94158-
Delta Waves, Inc. /ID# 151727Colorado SpringsColorado80918-
South Denver Gastroenterology /ID# 151224Lone TreeColorado80124-
Western States Clinical Res /ID# 158078Wheat RidgeColorado80033-2896-
Duplicate_Western Connecticut Medical Group /ID# 169211DanburyConnecticut06810-
Gastroenterology Center of Connecticut /ID# 150534HamdenConnecticut06518-
West Central Gastroenterology /ID# 155242ClearwaterFlorida33762-
Moonshine Research Center, Inc /ID# 152534DoralFlorida33166-
Universal Axon Clinical Research /ID# 213463DoralFlorida33166-
Palmetto Research, LLC /ID# 151724HialeahFlorida33016-
Nature Coast Clinical Research - Inverness /ID# 154070InvernessFlorida34452-4717-
Encore Borland-Groover Clinical Research /Id# 170913JacksonvilleFlorida32256-
SIH Research Mumtaz, Inc /ID# 163199KissimmeeFlorida34741-4161-
Cfagi Llc /Id# 202018MaitlandFlorida32751-6108-
Advanced Pharma CR, LLC /ID# 151723MiamiFlorida33147-
Coral Research Clinic /ID# 150524MiamiFlorida33186-4643-
Crystal Pharmacology Research /ID# 151848MiamiFlorida33165-
Duplicate_University of Miami /ID# 215443MiamiFlorida33136-
New Horizon Research Center /ID# 152475MiamiFlorida33165-3372-
Advanced Research Institute, Inc /ID# 163093New Port RicheyFlorida34653-
Endoscopic Research, Inc. /ID# 151725OrlandoFlorida32803-
Omega Research Group /ID# 200271OrlandoFlorida32808-
Clinical Research Trials of Florida, Inc. /ID# 201791TampaFlorida33607-
Duplicate_AdventHealth Tampa /ID# 200274TampaFlorida33613-4680-
Duplicate_University of South Florida /ID# 214494TampaFlorida33612-
Gastroenterology Associates of Central Georgia, LLC /ID# 165783MaconGeorgia31201-
Infinite Clinical Trials /ID# 215342RiverdaleGeorgia30274-
Atlanta Gastroenterology Spec /ID# 150565SuwaneeGeorgia30024-
Duplicate_The University of Chicago DCAM /ID# 150564ChicagoIllinois60637-
Next Innovative Clinical Research - Chicago /ID# 217323ChicagoIllinois60605-2168-
Duplicate_NorthShore University HealthSystem /ID# 150570EvanstonIllinois60201-
Northwest Health Care Associates /ID# 151591Hoffman EstatesIllinois60169-
Carle Foundation Hospital /ID# 151155UrbanaIllinois61801-
MediSphere Medical Research Center /ID# 152080EvansvilleIndiana47714-8011-
Indianapolis Gastroenterology /ID# 162914IndianapolisIndiana46237-
University of Iowa Hospitals and Clinics /ID# 157059Iowa CityIowa52242-
Cotton O'Neil Clinical Research Center, Digestive Health /ID# 167183TopekaKansas66606-
Tri-State Gastroenterology /ID# 169812Crestview HillsKentucky41017-
Houma Digestive Health Special /ID# 151851HoumaLouisiana70360-
Nola Research Works, LLC /ID# 153365New OrleansLouisiana70115-
Louisiana Research Center, LLC /ID# 150526ShreveportLouisiana71105-6800-
University of Maryland, Baltimore /ID# 150529BaltimoreMaryland21201-
Gastro Center of Maryland /ID# 200024ColumbiaMaryland21045-
Massachusetts General Hospital /ID# 165678BostonMassachusetts02114-
Huron Gastroenterology Assoc /ID# 152712Ann ArborMichigan48197-
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 151158Ann ArborMichigan48109-
Clin Res Inst of Michigan, LLC /ID# 153031ChesterfieldMichigan48047-
Clin Res Inst of Michigan, LLC /ID# 161983ChesterfieldMichigan48047-
Revival Research Institute, LLC /ID# 207281SouthfieldMichigan48034-1659-
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinic /ID# 157487WyomingMichigan49519-
Mayo Clinic - Rochester /ID# 151681RochesterMinnesota55905-0001-
Minnesota Gastroenterology PA /ID# 151682Saint PaulMinnesota55114-
Southern Therapy and Advanced Research (STAR) LLC /ID# 170713JacksonMississippi39216-
University of Mississippi Medical Center /ID# 213140JacksonMississippi39216-4500-
Washington University-School of Medicine /ID# 150537St LouisMissouri63110-
Vector Clinical Trials /ID# 153052Las VegasNevada89128-
Dartmouth-Hitchcock Medical Center /ID# 150566LebanonNew Hampshire03756-
Cooper Gastroenterology at Fire Road /ID# 153048Egg HarborNew Jersey08234-
Atlantic Digestive Health Inst /ID# 150527MorristownNew Jersey07960-
Rutgers Robert Wood Johnson /ID# 155247New BrunswickNew Jersey08901-
Duplicate_University of New Mexico Department of Internal Medicine /ID# 214399AlbuquerqueNew Mexico87131-
NY Scientific /ID# 152708BrooklynNew York11235-
Duplicate_NYU Langone Long Island Clinical Research Association /ID# 155271Great NeckNew York11021-
Columbia Univ Medical Center /ID# 163409New YorkNew York10032-3725-
Duplicate_DiGiovanna Institute for Medical Education & Research /ID# 201534North MassapequaNew York11758-
Premier Medical Group - GI Division /ID# 153366PoughkeepsieNew York12601-
Gastoenterology Group of Rochester /ID# 151080RochesterNew York14618-5703-
Richmond University Medical Center /ID# 201860Staten IslandNew York10310-1664-
Advantage Clinical Trials /ID# 163940The BronxNew York10468-
Montefiore Medical Center - Moses Campus /ID# 150559The BronxNew York10467-
Digestive Health Partners - Biltmore Office /ID# 167238AshevilleNorth Carolina28801-
Atrium Health Carolinas Medical Center /ID# 157060CharlotteNorth Carolina28203-
Charlotte Gastroenterology and Hepatology, PLLC /ID# 150561CharlotteNorth Carolina28207-
Atlantic Gastroenterology Clinical Research /ID# 151901GreenvilleNorth Carolina27834-
Clinical Trials of America /ID# 153453Winston-SalemNorth Carolina27103-
Duplicate_Atrium Health Wake Forest Baptist Medical Center /ID# 150528Winston-SalemNorth Carolina27157-0001-
Plains Clinical Research Center, LLC /ID# 170291FargoNorth Dakota58104-5925-
Gastro Health Research /ID# 151683CincinnatiOhio45219-
University Of Cincinnati Medical Center /ID# 164584CincinnatiOhio45219-
Optimed Research, Ltd. /ID# 169697ColumbusOhio43235-
The Ohio State University /ID# 169417ColumbusOhio43210-
Hometown Urgent Care and Resea /ID# 200066DaytonOhio45424-
Dayton Gastroenterology, Inc. /ID# 167632EnglewoodOhio45415-
Great Lakes Gastroenterology Research, LLC /ID# 201773MentorOhio44060-6211-
Ohio Clinical Research Partner /ID# 154074MentorOhio44060-
Digestive Disease Specialists /ID# 201057Oklahoma CityOklahoma73112-
Hightower Clinical /ID# 216338Oklahoma CityOklahoma73102-
Healthcare Research Consultant /ID# 163096TulsaOklahoma74135-
Options Health Research, LLC /ID# 150569TulsaOklahoma74104-
Northwest Gastroenterology Clinic /ID# 152528PortlandOregon97210-
Guthrie Medical Group, PC /ID# 150533SayrePennsylvania18840-
Penn State Health Colonnade /ID# 150267State CollegePennsylvania16803-2309-
Pharmacorp Clinical Trials /ID# 153363CharlestonSouth Carolina29412-
Gastroenterology Associates, P.A. of Greenville /ID# 150557GreenvilleSouth Carolina29607-
Gastro One /ID# 151154CordovaTennessee38018-
Duplicate_East Tennessee Research Institute /ID# 203611Johnson CityTennessee37604-
Quality Medical Research /ID# 203427NashvilleTennessee37211-
Vanderbilt University Medical Center /ID# 153364NashvilleTennessee37232-0011-
TX Clinical Research Institute /ID# 151528ArlingtonTexas76012-
Inquest Clinical Research /ID# 164636BaytownTexas77521-2415-
GI Alliance /ID# 209806Cedar ParkTexas78613-
Texas Digestive Disease Consultants /ID# 209949Cedar ParkTexas78613-5028-
Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 200771DallasTexas75246-
Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 151221GarlandTexas75044-
Centex Studies, Inc. - Houston /ID# 201217HoustonTexas77058-
CliniCore International, LLC /ID# 152078HoustonTexas77027-6812-
Duplicate_Baylor College of Medicine - Baylor Medical Center /ID# 150538HoustonTexas77030-3411-
GI Specialists of Houston /ID# 202337HoustonTexas77070-4347-
Vilo Research Group Inc /ID# 212626HoustonTexas77017-2337-
Duplicate_Caprock Gastro Research, LLC /ID# 215116LubbockTexas79424-3017-
Clinical Associates in Research Therapeutics of America, LLC /ID# 167954San AntonioTexas78212-
Southern Star Research Institute, LLC /ID# 169397San AntonioTexas78229-5390-
Carl R. Meisner Medical Clinic /ID# 171270Sugar LandTexas77478-
Baylor Scott & White Center for Diagnostic Medicine /ID# 204777TempleTexas76508-
Tyler Research Institute, LLC /ID# 169147TylerTexas75701-
Gastro Health & Nutrition - Victoria /ID# 167764VictoriaTexas77904-
HP Clinical Research /ID# 163941BountifulUtah84010-
Advanced Research Institute /ID# 162640OgdenUtah84405-
Utah Gastroenternology - St. Mark's Office /ID# 163097Salt Lake CityUtah84124-
Duplicate_Velocity Clinical Research - Salt Lake City /ID# 163180West JordanUtah84088-
Ctr for Gastrointestinal Healt /ID# 153369FranklinVirginia23851-
Texas Digestive Disease Consultants, PLLC dba GI Alliance /ID# 163630BellevueWashington98004-
The Polyclinic /ID# 165117SeattleWashington98122-4201-
Virginia Mason Hospital & Medical Center /ID# 153030SeattleWashington98101-
The Vancouver Clinic, INC. PS /ID# 162334VancouverWashington98664-
Aurora Medical Center - Grafto /ID# 151726GraftonWisconsin53024-
Duplicate_Medical College of Wisconsin /ID# 151850MilwaukeeWisconsin53226-3522-
Wisconsin Center for Advanced Research /ID# 151845MilwaukeeWisconsin53215-

Find similar trials in Mobile, AL

By research site
CB Flock Research Corporation· Mobile, ALEast View Medical Research, LLC· Mobile, ALDelsol Research Management, Ll· Chandler, AZDigestive Disease Consultants, A Division of Arizona Digestive Health, P.C· Mesa, AZDuplicate_Arizona Arthritis & Rheumatology Research, PLLC· Sun City, AZAdobe Clinical Research LLC· Tucson, AZ

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