A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug

Part of paid clinical trials in Mobile, Alabama.

Sponsor
AbbVie
Study ID
NCT03104374
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a Phase 3 multicenter study that included two periods. Period 1 was designed to compare the safety, tolerability, and efficacy of upadacitinib 15 mg once daily (QD) and 30 mg QD versus placebo in participants with moderately to severely active Psoriatic Arthritis (PsA) who had an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug (bDMARDs). Period 2 evaluated the safety, tolerability and efficacy of upadacitinib 15 mg QD and 30 mg QD in subjects with PsA who completed Period 1.

Key Dates

Start date
May 1, 2017
Status verified
Aug 2025
Primary completion
Jul 23, 2019
Completion
Sep 30, 2024

Study Design

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

Arms

  • Experimental: Upadacitinib 15 mg
    Administered once daily.
  • Placebo Comparator: Placebo / Upadacitinib 30 mg
    Administered once daily.
  • Experimental: Upadacitinib 30 mg
    Administered once daily.
  • Placebo Comparator: Placebo / Upadacitinib 15 mg
    Administered once daily.

Primary Outcome Measure

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12 [ Time Frame: Baseline and Week 12 ]

Locations (72)

FacilityCityStateZIPSite coordinators
Alabama Medical Group, PC /ID# 159836MobileAlabama36608-1787-
Arizona Arthritis & Rheumatology Research, PLLC /ID# 160047MesaArizona85210-6871-
Sun Valley Arthritis Center Ltd. /ID# 161203PeoriaArizona85381-
Duplicate_AZ Arthritis and Rheumotology Research, PLLC /ID# 160006PhoenixArizona85032-9306-
Osteoporosis Medical Center /ID# 161411Beverly HillsCalifornia90211-
Covina Arthritis Clinic /ID# 159919CovinaCalifornia91722-
Triwest Research Associates /ID# 159915El CajonCalifornia92020-
Duplicate_Providence Medical Foundation /ID# 160005FullertonCalifornia92835-
C.V. Mehta MD, Med Corporation /ID# 161192HemetCalifornia92543-
Care Access Research, Huntington Beach /ID# 160049Huntington BeachCalifornia92648-
Purushotham & Akther Kotha MD, Inc /ID# 159834La MesaCalifornia91942-
Stanford University School of Med /ID# 161402StanfordCalifornia94305-2200-
Inland Rheum Clin Trials Inc. /ID# 159839UplandCalifornia91786-
Medvin Clinical Research /ID# 160045WhittierCalifornia90606-
Denver Arthritis Clinic /ID# 159899DenverColorado80230-
Colorado Arthritis Associates /ID# 159856LakewoodColorado80228-
Duplicate_Arthritis & Rheumatic Disease Specialties /ID# 161409AventuraFlorida33180-
International Medical Research /ID# 160051Daytona BeachFlorida32117-
Precision Research Organization /ID# 161293Miami LakesFlorida33016-1501-
Duplicate_Suncoast Clinical Research /ID# 161417New Port RicheyFlorida34652-
Millennium Research /ID# 159833Ormond BeachFlorida32174-
Arthritis Center, Inc. /ID# 163463Palm HarborFlorida34684-
Gulf Region Clinical Res Inst /ID# 159860PensacolaFlorida32514-
Sarasota Arthritis Center /ID# 159854SarasotaFlorida34239-
BayCare Medical Group /ID# 161405St. PetersburgFlorida33705-
West Broward Rheumatology Associates /ID# 161412TamaracFlorida33321-
BayCare Medical Group, Inc. /ID# 159912TampaFlorida33614-7101-
Clinical Research of West Florida - Tampa /ID# 160069TampaFlorida33606-1246-
Clinical Research of West Florida, Inc /ID# 159840TampaFlorida33606-1246-
USF Health Morsani Center for /ID# 161291TampaFlorida33612-
Florida Medical Clinic /ID# 160013ZephyrhillsFlorida33542-
Jefrey D. Lieberman, MD, P.C. /ID# 159842DecaturGeorgia30033-
Atlanta Research Center for Rheumatology /ID# 161201MariettaGeorgia20060-
Velocity Clinical Research - Boise /ID# 159922MeridianIdaho83642-
Great Lakes Clinical Trials /ID# 163438ChicagoIllinois60640-
Deerbrook Medical Associates /ID# 159815LibertyvilleIllinois60048-
Duplicate_Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 160068SkokieIllinois60076-
The Arthritis & Diabetes Clinic, Inc. /ID# 161294MonroeLouisiana71203-
Arthritis Treatment Center /ID# 160053FrederickMaryland21204-
The Center for Rheumatology and Bone Research /ID# 159900WheatonMaryland20902-
Clinical Pharmacology Study Group /ID# 158712WorcesterMassachusetts01605-
Clinvest Research LLC /ID# 161208SpringfieldMissouri65807-
Westroads Clinical Research /ID# 160004OmahaNebraska68114-
Atlantic Coast Research /ID# 159810Toms RiverNew Jersey08755-
Duplicate_Arthritis and Osteo Assoc /ID# 160015Las CrucesNew Mexico88011-
Center for Rheumatology LLP /ID# 167046AlbanyNew York12203-3710-
St. Lawrence Health System /ID# 159857PotsdamNew York13676-
DJL Clinical Research, PLLC /ID# 161414CharlotteNorth Carolina28211-
Physicians East, PA /ID# 159898GreenvilleNorth Carolina27834-
Shanahan Rheuma & Immuno /ID# 160012RaleighNorth Carolina27617-
PMG Research of Wilmington LLC /ID# 161403WilmingtonNorth Carolina28401-
Trinity Health Med Arts Clinic /ID# 159811MinotNorth Dakota58701-
STAT Research, Inc. /ID# 161416VandaliaOhio45377-9464-
Health Research of Oklahoma /ID# 159913Oklahoma CityOklahoma73103-2400-
Altoona Ctr Clinical Res /ID# 159861DuncansvillePennsylvania16635-
University of Pittsburgh MC /ID# 161193PittsburghPennsylvania15260-
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 163462SummervilleSouth Carolina29486-7887-
Rheumatology Consultants, PLLC /ID# 161408KnoxvilleTennessee37909-
Dr. Ramesh Gupta /ID# 160067MemphisTennessee38119-
Tekton Research, Inc. /ID# 160008AustinTexas78745-
Diagnostic Group /ID# 161406BeaumontTexas77701-
Arthritis and Osteoporosis Clinic Of Brazos Valley /ID# 163439College StationTexas77845-
Adriana Pop-Moody MD Clinic PA /ID# 160009Corpus ChristiTexas78404-
Metroplex Clinical Research /ID# 159818DallasTexas75231-
Accurate Clinical Research /ID# 160052HoustonTexas77089-
Rheumatic Disease Clin Res Ctr /ID# 161252HoustonTexas77004-
P&I Clinical Research /ID# 159837LufkinTexas75904-3132-
SW Rheumatology Res. LLC /ID# 160014MesquiteTexas75150-
DM Clinical Research - Tomball /ID# 161753TomballTexas77375-
Arthritis & Osteoporosis Clinic /ID# 161400WacoTexas76710-
Arthritis Clinic of N. VA, P.C /ID# 159858ArlingtonVirginia22205-
Duplicate_Swedish Medical Center /ID# 159918SeattleWashington98104-

Find similar trials in Mobile, AL

By condition
Psoriatic arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Alabama Medical Group, PC· Mobile, ALArizona Arthritis & Rheumatology Research, PLLC· Mesa, AZSun Valley Arthritis Center Ltd.· Peoria, AZDuplicate_AZ Arthritis and Rheumotology Research, PLLC· Phoenix, AZOsteoporosis Medical Center· Beverly Hills, CACovina Arthritis Clinic· Covina, CA

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