A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies

Part of paid clinical trials in Mobile, Alabama.

Sponsor
AbbVie
Study ID
NCT03345849
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in adults with moderately and severely active Crohn's disease (CD).

Key Dates

Start date
Dec 7, 2017
Status verified
Oct 2022
Primary completion
Oct 15, 2021
Completion
Jan 13, 2022

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Participants will receive placebo once daily for 12 weeks in Part 1. Clinical non-responders will receive 45 mg upadacitinib once daily for 12 weeks in Part 2.
  • Experimental: Upadacitinib
    Participants will receive 45 mg upadacitinib once daily for 12 weeks in Part 1. Clinical non-responders will receive 30 mg upadacitinib once daily for 12 weeks in Part 2.

Primary Outcome Measure

Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12 [ Time Frame: Week 12 ]

Locations (119)

FacilityCityStateZIPSite coordinators
CB Flock Research Corporation /ID# 166185MobileAlabama36608-
East View Medical Research, LLC /ID# 171176MobileAlabama36606-
Delsol Research Management, Ll /Id# 170145ChandlerArizona85224-
HonorHealth Research Institute - Shea /ID# 164821ScottsdaleArizona85258-
Arizona Arthritis & Rheumatology Research, PLLC /ID# 164803Sun CityArizona85306-
Southern California Res. Ctr. /ID# 169655CoronadoCalifornia92118-1408-
Citrus Valley Gastroenterology /ID# 166173CovinaCalifornia91722-3797-
Hoag Memorial Hosp Presbyterian /ID# 222540IrvineCalifornia92618-
United Medical Doctors /ID# 207449Los AlamitosCalifornia90720-3309-
Gastrointestinal Biosciences Clinical Trials, LLC /ID# 164762Los AngelesCalifornia90067-2001-
Facey Medical Foundation /ID# 203136Mission HillsCalifornia91345-
United Medical Doctors - Murrieta /ID# 164945MurrietaCalifornia92563-
Medical Assoc Research Grp /ID# 169706San DiegoCalifornia92123-
Ucsd /Id# 164910San DiegoCalifornia92103-
Univ of California San Francis /ID# 164944San FranciscoCalifornia94158-
Care Access Research /ID# 167767San PabloCalifornia94806-
Delta Waves, Inc. /ID# 164776Colorado SpringsColorado80918-
Peak Gastroenterology Associates, PC /ID# 170143Colorado SpringsColorado80907-
Western States Clinical Res /ID# 164760Wheat RidgeColorado80033-2896-
Medical Research Center of CT /ID# 164926HamdenConnecticut06518-
Clinical Research of West Florida, Inc /ID# 205827ClearwaterFlorida33765-
Clinical Research of West Florida, Inc /ID# 208118ClearwaterFlorida33765-
Advanced Research - Coral Springs /ID# 218021Coral SpringsFlorida33067-3173-
Encore Borland-Groover Clinical Research /Id# 203499JacksonvilleFlorida32256-
Ctr for Advanced Gastroenterol /ID# 165353MaitlandFlorida32751-6108-
Coral Research Clinic /ID# 164890MiamiFlorida33186-4643-
Crystal Pharmacology Research /ID# 166081MiamiFlorida33165-
Advanced Research Institute, Inc /ID# 164921New Port RicheyFlorida34653-
Endoscopic Research, Inc. /ID# 206136OrlandoFlorida32803-
Omega Research Maitland, LLC /ID# 203481OrlandoFlorida32808-
AdventHealth Tampa /ID# 171167TampaFlorida33613-4680-
Clinical Research Trials of Florida, Inc. /ID# 203485TampaFlorida33607-
Gastroenterology Associates of Central Georgia, LLC /ID# 165478MaconGeorgia31201-
Gastroenterology Consultants PC - Roswell /ID# 218220RoswellGeorgia30076-4913-
Atlanta Gastroenterology Spec /ID# 164799SuwaneeGeorgia30024-
Treasure Valley Medical Research /ID# 215032BoiseIdaho83706-
Rush University Medical Center /ID# 165497ChicagoIllinois60612-
University of Chicago Medicine /ID# 165503ChicagoIllinois60637-1426-
DuPage Medical Group /ID# 205328Downers GroveIllinois60515-5509-
MediSphere Medical Research Center /ID# 166175EvansvilleIndiana47714-8011-
Indianapolis Gastroenterology /ID# 164938IndianapolisIndiana46237-
University of Iowa Hospitals and Clinics /ID# 165436Iowa CityIowa52242-
Tri-State Gastroenterology /ID# 165496Crestview HillsKentucky41017-
University of Louisville /ID# 165366LouisvilleKentucky40202-
University of Louisville /ID# 168572LouisvilleKentucky40202-
CroNOLA, LLC /ID# 164823HoumaLouisiana70360-
Nola Research Works, LLC /ID# 164759New OrleansLouisiana70115-
Louisana Research Center, LLC /ID# 164894ShreveportLouisiana71105-6800-
Johns Hopkins University School of Medicine /ID# 211941BaltimoreMaryland21287-0010-
MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 164935Chevy ChaseMaryland20815-
Gastro Center of Maryland /ID# 171161ColumbiaMaryland21045-
Lahey Hospital and Medical Center /ID# 214726BurlingtonMassachusetts01805-
University of Michigan Comprehensive Cancer Center Michigan Medicine /ID# 164943Ann ArborMichigan48109-
Digestive Health Associates (DHA) - Farmington Hills /ID# 205793Farmington HillsMichigan48334-3230-
Center for Digestive Health /ID# 164822TroyMichigan48098-6363-
Clin Res Inst of Michigan, LLC /ID# 170133TroyMichigan48098-
Mayo Clinic - Rochester /ID# 164783RochesterMinnesota55905-0001-
Southern Therapy and Advanced Research (STAR) LLC /ID# 165343JacksonMississippi39216-
Duplicate_CHI Nebraska d/b/a CHI Health /ID# 168578OmahaNebraska68124-
Quality Clinical Research Inc. /ID# 170137OmahaNebraska68114-3723-
Las Vegas Medical Research /ID# 168588Las VegasNevada89113-
AGA Clinical Research Associates, LLC /ID# 164769Egg HarborNew Jersey08234-
Rutgers Robert Wood Johnson /ID# 166073New BrunswickNew Jersey08901-
NY Scientific /ID# 164931BrooklynNew York11235-
United Health Services Hospitals, Inc /ID# 217485Johnson CityNew York13790-2107-
NYU Langone Long Island Clinical Research Associates /ID# 164927Lake SuccessNew York11042-
Columbia Univ Medical Center /ID# 164782New YorkNew York10032-3725-
The Mount Sinai Hospital /ID# 170257New YorkNew York10029-
Gastoenterology Group of Rochester /ID# 166177RochesterNew York14618-5703-
Richmond University Medical Center /ID# 201857Staten IslandNew York10310-1664-
Advantage Clinical Trials /ID# 168546The BronxNew York10468-
Montefiore Medical Center - Moses Campus /ID# 166193The BronxNew York10467-
Atrium Health Carolinas Medical Center /ID# 164932CharlotteNorth Carolina28203-
PMG Research of Charlotte /ID# 171160CharlotteNorth Carolina28209-
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 164904RaleighNorth Carolina27612-
Wake Forest Baptist Medical Center /ID# 164908Winston-SalemNorth Carolina27157-0001-
Plains Clinical Research Center, LLC /ID# 170140FargoNorth Dakota58104-5925-
Gastro Health Research /ID# 164791CincinnatiOhio45219-
University of Cincinnati /ID# 164825CincinnatiOhio45267-0585-
Cleveland Clinic Main Campus /ID# 209231ClevelandOhio44195-
Optimed Research, Ltd. /ID# 205624ColumbusOhio43235-
The Ohio State University /ID# 170141ColumbusOhio43210-
Hometown Urgent Care and Resea /ID# 201291DaytonOhio45424-
Dayton Gastroenterology, Inc. /ID# 167627EnglewoodOhio45415-
Great Lakes Medical Research, LLC /ID# 202010MentorOhio44060-6211-
Digestive Disease Specialists /ID# 201064Oklahoma CityOklahoma73112-
Healthcare Research Consultant /ID# 166195TulsaOklahoma74135-
Options Health Research, LLC /ID# 164820TulsaOklahoma74104-
University of Pennsylvania /ID# 168430PhiladelphiaPennsylvania19104-5502-
Pharmacorp Clinical Trials /ID# 164916CharlestonSouth Carolina29412-
Gastroenterology Associates, P.A. of Greenville /ID# 164771GreenvilleSouth Carolina29615-3593-
Rapid City Medical Center - GI Research /ID# 201735Rapid CitySouth Dakota57701-
Gastro One /ID# 164826GermantownTennessee38138-
East Tennessee Research Institute /ID# 203613Johnson CityTennessee37604-
Quality Medical Research /ID# 205263NashvilleTennessee37211-
Vanderbilt University Medical Center /ID# 164946NashvilleTennessee37232-0011-
TX Clinical Research Institute /ID# 164896ArlingtonTexas76012-
Inquest Clinical Research /ID# 164785BaytownTexas77521-2415-
Texas Digestive Disease Consultants /ID# 209801Cedar ParkTexas78613-
Texas Digestive Disease Consultants /ID# 209953Cedar ParkTexas78613-5028-
Baylor Scott & White Center for Inflammatory Bowel Diseases /ID# 170144DallasTexas75246-
Baylor College of Medicine - Baylor Medical Center /ID# 164947HoustonTexas77030-3411-
Centex Studies, Inc. - Houston /ID# 201214HoustonTexas77058-
CliniCore International, LLC /ID# 164902HoustonTexas77027-6812-
GI Specialists of Houston /ID# 202339HoustonTexas77070-4347-
Caprock Gastro Research, LLC /ID# 215438LubbockTexas79424-3017-
Clinical Associates in Research Therapeutics of America, LLC /ID# 164786San AntonioTexas78212-
Southern Star Research Institute, LLC /ID# 169755San AntonioTexas78229-5390-
Carl R. Meisner Medical Clinic /ID# 201061Sugar LandTexas77478-
Tyler Research Institute, LLC /ID# 168687TylerTexas75701-4464-
Gastro Health & Nutrition - Victoria /ID# 167812VictoriaTexas77904-
HP Clinical Research /ID# 164933BountifulUtah84010-
Advanced Research Institute /ID# 164784OgdenUtah84403-
Duplicate_Care Access Research /ID# 164794Salt Lake CityUtah84124-1377-
Velocity Clinical Research - Salt Lake City /ID# 166076West JordanUtah84088-
Washington Gastroenterology /ID# 164824BellevueWashington98004-
Virginia Mason Medical Center /ID# 164913SeattleWashington98101-
The Vancouver Clinic, INC. PS /ID# 164918VancouverWashington98664-
Allegiance Research Specialists /ID# 165346WauwatosaWisconsin53226-

Find similar trials in Mobile, AL

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
CB Flock Research Corporation· Mobile, ALEast View Medical Research, LLC· Mobile, ALDelsol Research Management, Ll· Chandler, AZHonorHealth Research Institute - Shea· Scottsdale, AZArizona Arthritis & Rheumatology Research, PLLC· Sun City, AZSouthern California Res. Ctr.· Coronado, CA

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