A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)

Part of paid clinical trials in Anniston, Alabama.

Sponsor
AbbVie
Study ID
NCT03671148
Phase
PHASE3
Status
Completed

Conditions

  • Psoriatic Arthritis (PsA)

Eligibility Criteria

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

Interventions

  • Placebo — BIOLOGICAL
    Placebo for risankizumab administered by subcutaneous (SC) injection
  • Risankizumab — BIOLOGICAL
    Risankizumab administered by subcutaneous (SC) injection

Study Details

The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).

Key Dates

First listed
Sep 14, 2018
Start date
Mar 7, 2019
Status verified
Jun 2026
Primary completion
Jun 22, 2020
Completion
Jun 4, 2026

Study Design

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

Arms

  • Experimental: Risankizumab
    Participants randomized to receive 150 mg risankizumab administered by subcutaneous injection at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive blinded placebo followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.
  • Placebo Comparator: Placebo
    Participants randomized to receive double-blind placebo at Week 0, Week 4, and Week 16 in Period 1. At Week 24 participants will receive 150 mg risankizumab followed by open-label 150 mg risankizumab at Week 28, and every 12 weeks thereafter in Period 2 until the final dosing time point at Week 316.

Primary Outcome Measure

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 [ Time Frame: Baseline and Week 24 ]

Locations (55)

FacilityCityStateZIPSite coordinators
Pinnacle Research Group /ID# 167953AnnistonAlabama36207-
St. Jude Heritage /ID# 166842FullertonCalifornia92835-
Newport Huntington Medica /ID# 207423Huntington BeachCalifornia92648-5994-
Arthritis & Osteo Medical Ctr /ID# 166541La PalmaCalifornia90623-1728-
East Bay Rheumatology Medical /ID# 166845San LeandroCalifornia94578-
Inland Rheum Clin Trials Inc. /ID# 166621UplandCalifornia91786-
Denver Arthritis Clinic /ID# 166442DenverColorado80230-
New England Research Associates, LLC /ID# 166525BridgeportConnecticut06606-1827-
Yale University /ID# 166330New HavenConnecticut06510-
Arthritis & Rheumatic Disease Specialties /ID# 212582AventuraFlorida33180-
SIMED Health, LLC /ID# 207457GainesvilleFlorida32607-2817-
Sweet Hope Research Specialty Inc /ID# 168163HialeahFlorida33016-1897-
HMD Research LLC /ID# 208428OrlandoFlorida32819-
Rheum Assoc of Central FL /ID# 201629OrlandoFlorida32806-
Millennium Research /ID# 201627Ormond BeachFlorida32174-
Arthritis Center, Inc. /ID# 208116Palm HarborFlorida34684-
IRIS Research and Development, LLC /ID# 166351PlantationFlorida33324-
BayCare Medical Group /ID# 201630St. PetersburgFlorida33705-
West Broward Rheumatology Associates /ID# 201234TamaracFlorida33321-
ForCare Clinical Research /ID# 166375TampaFlorida33613-1244-
University of South Florida /ID# 208467TampaFlorida33612-
Arthritis and Rheumatology /ID# 169438AtlantaGeorgia30342-
Clinic of Robert Hozman/Clinical Investigation Specialists /ID# 166681SkokieIllinois60076-
Springfield Clinic /ID# 166345SpringfieldIllinois62702-3749-
Ochsner Clinic Foundation /ID# 166622Baton RougeLouisiana70836-6455-
The Arthritis & Diabetes Clinic, Inc. /ID# 166707MonroeLouisiana71203-
MMP Women's Health /ID# 169334PortlandMaine04102-
Klein and Associates MD /ID# 166549HagerstownMaryland21740-
Duplicate_The Center for Rheumatology & Bone Research /ID# 166448WheatonMaryland20902-
Clinical Pharmacology Study Gr /ID# 166455WorcesterMassachusetts01605-
St. Paul Rheumatology /ID# 166599EaganMinnesota55121-
Clinvest Research LLC /ID# 166745SpringfieldMissouri65810-2607-
Clayton Medical Associates, P.C. dba Saint Louis Rheumatology /ID# 166389St LouisMissouri63119-3845-
Glacier View Research Institute /ID# 169344KalispellMontana59901-
Dartmouth-Hitchcock Medical Center /ID# 169443LebanonNew Hampshire03756-
Ocean Rheumatology, PA /ID# 166561Toms RiverNew Jersey08755-
Arthritis Rheumatic and Back Disease Associates. P.A. /ID# 166658Voorhees TownshipNew Jersey08043-
Paramount Medical Research Con /ID# 166334Middleburg HeightsOhio44130-
Health Research of Oklahoma /ID# 166408Oklahoma CityOklahoma73103-2400-
Altoona Ctr Clinical Res /ID# 166691DuncansvillePennsylvania16635-
Clinical Research Ctr Reading /ID# 166354WyomissingPennsylvania19610-
West Tennessee Research Institute /ID# 166429JacksonTennessee38305-
Nashville Arthritis and Rheumatology /ID# 208395NashvilleTennessee37203-
Amarillo Ctr for Clin Research /ID# 208340AmarilloTexas79124-
Tekton Research, Inc. /ID# 166493AustinTexas78745-
Precision Comprehensive Clinical Research Solutions /ID# 208156ColleyvilleTexas76034-
Rheumatology Clinic of Houston /ID# 166636HoustonTexas77065-
West Texas Clinical Research /ID# 208155LubbockTexas79410-1198-
SW Rheumatology Res. LLC /ID# 166587MesquiteTexas75150-
Trinity Universal Research Associates, Inc /ID# 208387PlanoTexas75024-5283-
DM Clinical Research /ID# 208350TomballTexas77375-
Kadlec Clinic Rheumatology /ID# 167667KennewickWashington99336-
Arthritis Northwest, PLLC /ID# 169535SpokaneWashington99204-2302-
Rheumatology and Pulmonary Clinic /ID# 169341BeckleyWest Virginia25801-
Rheumatic Disease Center, LLP /ID# 166682GlendaleWisconsin53217-

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Pinnacle Research Group· Anniston, ALSt. Jude Heritage· Fullerton, CANewport Huntington Medica· Huntington Beach, CAArthritis & Osteo Medical Ctr· La Palma, CAEast Bay Rheumatology Medical· San Leandro, CAInland Rheum Clin Trials Inc.· Upland, CA

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