A Study Comparing Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone

Part of paid clinical trials in Mesa, Arizona.

Sponsor
AbbVie
Study ID
NCT02675426
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo — DRUG
    Tablet; Oral
  • Upadacitinib — DRUG
    Tablet; Oral

Study Details

The primary objectives of this study are to compare the efficacy, safety, and tolerability of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of adults with moderately to severely active rheumatoid arthritis who were on a stable dose of csDMARDs and had an inadequate response to csDMARDs.

Key Dates

Start date
Dec 17, 2015
Status verified
Mar 2023
Primary completion
Apr 21, 2017
Completion
Mar 10, 2022

Study Design

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

Arms

  • Experimental: Upadacitinib 15 mg
    Period 1: Participants receive upadacitinib 15 mg once daily for 12 weeks. Period 2: Participants continue to receive upadacitinib 15 mg once daily for an additional 248 weeks.
  • Experimental: Upadacitinib 30 mg
    Period 1: Participants receive upadacitinib 30 mg once daily for 12 weeks. Period 2: Participants continue to receive upadacitinib 30 mg once daily for an additional 248 weeks or until implementation of Protocol Amendment 6 at which time participants switch to receive upadacitinib 15 mg once daily.
  • Experimental: Placebo / Upadacitinib 15 mg
    Period 1: Participants receive placebo once daily for 12 weeks. Period 2: Participants receive upadacitinib 15 mg once daily for 248 weeks.
  • Experimental: Placebo / Upadacitinib 30 mg
    Period 1: Participants receive placebo once daily for 12 weeks. Period 2: Participants receive upadacitinib 30 mg once daily for 248 weeks or until implementation of Protocol Amendment 6 at which time participants switch to receive upadacitinib 15 mg 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 (57)

FacilityCityStateZIPSite coordinators
AZ Arthritis and Rheum Assoc /ID# 148651MesaArizona85202-
SunValley Arthritis Center, Lt /ID# 140452PeoriaArizona85381-
Arizona Research Center, Inc. /ID# 140448PhoenixArizona85053-4061-
AZ Arthritis & Rheuma Research /ID# 138598PhoenixArizona85032-
AZ Arthritis and Rheum Researc /ID# 138500PhoenixArizona85032-9306-
AZ Arthritis and Rheum Researc /ID# 139286PhoenixArizona85032-9306-
University of Arizona Cancer Center - North Campus /ID# 140451TucsonArizona85719-1478-
Covina Arthritis Clinic /ID# 139881CovinaCalifornia91722-
T. Joseph Raoof, MD, Inc. /ID# 140964EncinoCalifornia91436-
Allergy and Rheum Med Clin /ID# 146082La JollaCalifornia92037-
Pacific Arthritis Ctr Med Grp /ID# 138744Los AngelesCalifornia90045-
Robin K. Dore MD, Inc /ID# 138688TustinCalifornia92780-
Inland Rheum Clin Trials Inc. /ID# 138853UplandCalifornia91786-
Denver Arthritis Clinic /ID# 139876DenverColorado80230-
Clinical Res of West FL, Inc. /ID# 138854ClearwaterFlorida33765-
Ctr Arthritis & Rheumatic Dise /ID# 141696MiamiFlorida33173-
Medallion Clinical Research Institute, LLC /ID# 140074NaplesFlorida34102-
Suncoast Clinical Research /ID# 138633New Port RicheyFlorida34652-
Omega Research Consultants /ID# 139877OrlandoFlorida32810-
Arthritis Center, Inc. /ID# 141363Palm HarborFlorida34684-
Institute of Arthritis Res /ID# 138548Idaho FallsIdaho83404-
OrthoIllinois /ID# 139695RockfordIllinois61114-4937-
Clinical Investigation Special /ID# 139696SkokieIllinois60076-
Springfield Clinic /ID# 138602SpringfieldIllinois62702-3749-
Deerbrook Medical Associates /ID# 139694Vernon HillsIllinois60061-
Indiana Univ School of Med /ID# 140077IndianapolisIndiana46202-
Bluegrass Community Research /ID# 138295LexingtonKentucky40515-
Four Rivers Clinical Research /ID# 141134PaducahKentucky42003-
MMP Women's Health /ID# 141542PortlandMaine04102-
The Center for Rheumatology & /ID# 139203WheatonMaryland20902-
Mansfield Health Center /ID# 141357MansfieldMassachusetts02048-
Advanced Rheumatology, PC /ID# 140071LansingMichigan48910-
Justus J. Fiechtner, MD, PC /ID# 138697LansingMichigan48910-
Physician Res. Collaboration /ID# 138533LincolnNebraska68516-
Westroads Clinical Research /ID# 138304OmahaNebraska68114-
The Center for Rheumatology /ID# 138746AlbanyNew York12206-
PMG Research of Salisbury /ID# 141023SalisburyNorth Carolina28144-
PMG Research of Wilmington LLC /ID# 140951WilmingtonNorth Carolina28401-
Cincinnati Rheumatic Disease Study Group, Inc. /ID# 138868CincinnatiOhio45242-4468-
Arthritis Assoc of NW Ohio /ID# 140953ToledoOhio43606-
Health Research Oklahoma /ID# 138535Oklahoma CityOklahoma73103-2400-
Altoona Ctr Clinical Res /ID# 138741DuncansvillePennsylvania16635-
Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 138689SummervilleSouth Carolina29486-7887-
Comprehensive Arthritis Care, a division of Comprehensive Rheumatology Care PLLC /ID# 141021HendersonvilleTennessee37075-6213-
Tekton Research, Inc. /ID# 141428AustinTexas78745-
Trinity Universal Res Assoc /ID# 149271CarrolltonTexas75007-
Arth and Osteo Clin Brazo Valley /ID# 147809College StationTexas77845-
Metroplex Clinical Research /ID# 138698DallasTexas75231-
Baylor College of Medicine /ID# 138682HoustonTexas77030-3411-
Houston Institute for Clin Res /ID# 138716HoustonTexas77074-
Arthritis Consultants, P.A. /ID# 141138KilleenTexas76549-
Trinity Universal Research Association /ID# 148649PlanoTexas75024-5283-
Accurate Clinical Management /ID# 139338San AntonioTexas78229-
Arthritis & Osteoporosis Clinic /ID# 138703WacoTexas76710-
Western Washington Arthritis C /ID# 138728BothellWashington98021-
Arthritis Northwest, PLLC /ID# 138539SpokaneWashington99204-
Aurora Rheumatology and Immunotherapy Center /ID# 139306FranklinWisconsin53132-

Find similar trials in Mesa, AZ

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
AZ Arthritis and Rheum Assoc· Mesa, AZSunValley Arthritis Center, Lt· Peoria, AZArizona Research Center, Inc.· Phoenix, AZAZ Arthritis & Rheuma Research· Phoenix, AZAZ Arthritis and Rheum Researc· Phoenix, AZUniversity of Arizona Cancer Center - North Campus· Tucson, AZ

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