AzTrials
AzTrials

Psoriatic ArthritisPhase 3KEEPsAKE 1NCT03675308

A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy

A Phase 3 study testing Risankizumab in people with Psoriatic Arthritis, run by AbbVie at 256 sites in 39 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in participants with moderately to severely active psoriatic arthritis (PsA). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Psoriatic Arthritis
What is being tested?
Risankizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
964 participants
Where
256 sitesin 39 countries
Study dates
25 Mar 2019to 28 Sep 2026
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at the Screening Visit.
  • Participant has active disease at Baseline defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts)
  • Diagnosis of active plaque psoriasis with at least one psoriatic plaque of ≥ 2 cm diameter or nail changes consistent with psoriasis at Screening Visit.
  • Participant has demonstrated an inadequate response or intolerance to or contraindication for conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).
  • Presence of either at Screening:
  • ≥ 1 erosion on radiograph as determined by central imaging review or;
  • High sensitivity C-reactive protein (hsCRP) ≥ 3.0 mg/L.

Who cannot join

  • Participant is considered by investigator, for any reason, to be an unsuitable candidate for the study.
  • Participant has a known hypersensitivity to risankizumab.
  • Participant has previous treatment with biologic agent.

Trial locations and contacts

256 sites in 39 countries.

256 sites in 39 countries

United States59 sites

  • Center for Rheumatology LLP /ID# 207313

    Albany, New York, 12203-3710

  • Amarillo Ctr for Clin Research /ID# 208347

    Amarillo, Texas, 79124

  • Pinnacle Research Group /ID# 167955

    Anniston, Alabama, 36207

  • Arthritis and Rheumatology /ID# 168046

    Atlanta, Georgia, 30342

  • Arthritis & Rheumatic Disease Specialties /ID# 210802

    Aventura, Florida, 33180

  • Rheumatology and Pulmonary Clinic /ID# 200446

    Beckley, West Virginia, 25801

  • Velocity Clinical Research /ID# 200452

    Blue Ash, Ohio, 45242-3763

  • Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 211099

    Boca Raton, Florida, 33486

  • New England Research Associates, LLC /ID# 207237

    Bridgeport, Connecticut, 06606-1827

  • NYU Langone Ambulatory Care Brooklyn Heights /ID# 207310

    Brooklyn, New York, 11201

  • Joint & Muscle Research Instit /ID# 208620

    Charlotte, North Carolina, 28204

  • Precision Comprehensive Clinical Research Solutions /ID# 208386

    Colleyville, Texas, 76034

  • Dallas VA Medical Center /ID# 208389

    Dallas, Texas, 75216

  • Danbury Clinical Research, LLC /ID# 209517

    Danbury, Connecticut, 06810

  • Altoona Ctr Clinical Res /ID# 168037

    Duncansville, Pennsylvania, 16635

  • St. Paul Rheumatology /ID# 208471

    Eagan, Minnesota, 55121

  • Precision Comprehensive Clinical Research Solutions /ID# 210597

    Fort Worth, Texas, 76107

  • Aurora Rheumatology and Immunotherapy Center /ID# 168066

    Franklin, Wisconsin, 53132

  • SIMED Health, LLC /ID# 207461

    Gainesville, Florida, 32607-2817

  • Medication Management, LLC /ID# 211734

    Greensboro, North Carolina, 27408

  • Klein and Associates MD /ID# 169483

    Hagerstown, Maryland, 21740

  • Arthritis & Osteoporosis Center /ID# 207236

    Hamden, Connecticut, 06518

  • Sweet Hope Research Specialty Inc /ID# 209393

    Hialeah, Florida, 33016-1897

  • Jacksonville Center for Clinical Research /ID# 209876

    Jacksonville, Florida, 32216

  • Arthritis and Rheumatism Associates /ID# 209882

    Jonesboro, Arkansas, 72401-6251

  • Logan Health Research /ID# 213707

    Kalispell, Montana, 59901

  • Kadlec Clinic Rheumatology /ID# 207969

    Kennewick, Washington, 99336

  • Advanced Rheumatology, PC /ID# 168042

    Lansing, Michigan, 48910

  • June DO, PC /ID# 208915

    Lansing, Michigan, 48910

  • Physician Research Collaboration, LLC /ID# 208670

    Lincoln, Nebraska, 68516

  • Valerius Medical Group & Research Center /ID# 207428

    Los Alamitos, California, 90720-5402

  • Holy Family Memorial, Inc. /ID# 209387

    Manitowoc, Wisconsin, 54220

  • Marietta Memorial Hospital /ID# 210179

    Marietta, Ohio, 45750-1635

  • Paramount Medical Research Con /ID# 201583

    Middleburg Heights, Ohio, 44130

  • Nashville Arthritis and Rheumatology /ID# 168069

    Nashville, Tennessee, 37203

  • Coastal Carolina Health Care /ID# 208619

    New Bern, North Carolina, 28562

  • Affinity Clinical Research /ID# 210816

    Oak Brook, Illinois, 60523-1245

  • Health Research of Oklahoma /ID# 168027

    Oklahoma City, Oklahoma, 73103-2400

  • Gundersen Clinic, Ltd /ID# 209459

    Onalaska, Wisconsin, 54650

  • Rheum Assoc of Central FL /ID# 201622

    Orlando, Florida, 32806

  • HMD Research LLC /ID# 208427

    Orlando, Florida, 32819

  • Sun Valley Arthritis Center Ltd. /ID# 200270

    Peoria, Arizona, 85381

  • AZ Arthritis and Rheumotology Research, PLLC /ID# 209873

    Phoenix, Arizona, 85032-9306

  • Allegheny Health Network Research Institute /ID# 210349

    Pittsburgh, Pennsylvania, 15212-4756

  • IRIS Research and Development, LLC /ID# 208955

    Plantation, Florida, 33324

  • OrthoIllinois /ID# 205300

    Rockford, Illinois, 61114-4937

  • Rheumatology Center of San Diego /ID# 201642

    San Diego, California, 92128-2549

  • STAT Research, Inc. /ID# 213805

    Springboro, Ohio, 45066

  • Springfield Clinic /ID# 200244

    Springfield, Illinois, 62702-3749

  • ForCare Clinical Research /ID# 168034

    Tampa, Florida, 33613-1244

  • Advanced Rheumatology of Houston /ID# 208354

    The Woodlands, Texas, 77382

  • DM Clinical Research /ID# 208351

    Tomball, Texas, 77375

  • Arizona Arthritis & Rheumatology Research, PLLC /ID# 209875

    Tucson, Arizona, 85704

  • Southern Arizona VA Health Care System /ID# 209247

    Tucson, Arizona, 85723

  • Inland Rheum Clin Trials Inc. /ID# 201641

    Upland, California, 91786

  • The Center for Rheumatology and Bone Research /ID# 168017

    Wheaton, Maryland, 20902

  • Medvin Clinical Research /ID# 211127

    Whittier, California, 90606

  • Clinical Pharmacology Study Gr /ID# 168019

    Worcester, Massachusetts, 01605

  • Clinical Research Ctr Reading /ID# 168070

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Argentina12 sites

  • Hospital General de Agudos J. M. Ramos Mejia /ID# 169164

    Buenos Aires, Ciuadad Autonoma de Buenos Aires, 1221

  • Duplicate_Inst de Rehab Psicofisica /ID# 214681

    Buenos Aires, 2201

  • Hospital Italiano de Buenos Aires /ID# 208474

    Ciudad Autonoma Buenos Aires, Ciuadad Autonoma de Buenos Aires, 1199

  • DOM Centro de Reumatologia /ID# 208479

    Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1111

  • Fundacion CIDEA /ID# 210494

    Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1121

  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 211622

    Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma de Buenos Aires, 1426

  • Duplicate_Hospital Privado Univesitario /ID# 211623

    Córdoba, 5016

  • Framingham Centro Medico /ID# 210409

    La Plata, Buenos Aires, 1902

  • Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 169163

    Rosario, Santa Fe Province, 2000

  • Instituto CAICI /ID# 169168

    Rosario, Santa Fe Province, 2000

  • Centro Medico Privado de Reumatologia /ID# 208343

    San Miguel de Tucumán, Tucumán Province, 4000

  • Cimer /Id# 169167

    San Miguel de Tucumán, 4000

Other trials in Argentina

Ukraine12 sites

  • CNE Cherkasy Regional Hospital of Cherkasy Regional Council /ID# 207912

    Cherkasy, 18009

  • MNPE Chernihiv Regional Hospital of the Chernihiv Region Council /ID# 207730

    Chernihiv, 14029

  • State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 209556

    Kharkiv, Kharkiv Oblast, 61039

  • PNE City Multifunctional Hospital No.18 /ID# 207911

    Kharkiv, 61029

  • Khmelnytskyi Regional Hospital /ID# 207753

    Khmelnytskyi, 29000

  • MI Kryvyi Rih City Clinical Hospital No.2 /ID# 207748

    Kryvyi Rih, 50056

  • Medical Center OK Clinic /ID# 207749

    Kyiv, 02091

  • Communal Enterprise Volyn Regional Clinical hospital of the Volyn Regional Coun /ID# 208276

    Lutsk, 43005

  • Lviv Municipal City Clinical Hospital #4 /ID# 207715

    Lviv, 79011

  • PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 207872

    Poltava, 36011

  • Scientific Research Institute of Invalid Rehabilitation /ID# 207873

    Vinnytsia, Vinnytsia Oblast, 21029

  • Public Institution 6th City Clinical Hospital /ID# 207754

    Zaporizhzhya, 69035

Other trials in Ukraine

Poland9 sites

  • Osteo-Medic S.C. /ID# 208008

    Bialystok, Podlaskie Voivodeship, 15-351

  • ClinicMed Daniluk, Nowak Sp.j. /ID# 210824

    Bialystok, Podlaskie Voivodeship, 15-879

  • Spolka Lekarzy INTERCOR /ID# 210191

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-605

  • Centrum Kliniczno-Badawcze /ID# 208010

    Elblag, Warmian-Masurian Voivodeship, 82-300

  • McBk Sc /Id# 209132

    Grodzisk Mazowiecki, Masovian Voivodeship, 05-825

  • Malopolskie Centrum Kliniczne /ID# 208007

    Krakow, Lesser Poland Voivodeship, 30-149

  • ETYKA-Osrodek Badan Klinicznych /ID# 216241

    Olsztyn, Warmian-Masurian Voivodeship, 10-117

  • Nasz Lekarz Przychodnie Medyczne /ID# 216176

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Centrum Medyczne Reuma Park w Warszawie /ID# 210352

    Warsaw, Masovian Voivodeship, 02-691

Other trials in Poland

Russia8 sites

  • Kazan State Medical University /ID# 169511

    Kazan', Tatarstan, Respublika, 420012

  • LLC Family Outpatient Clinic № /ID# 169510

    Korolev, Moscow, 141060

  • Research Institute of Rheumatology named after V.A. Nasonova /ID# 207643

    Moscow, Moscow, 115522

  • Federal Center for Brain and Neurotechnology /ID# 207646

    Moscow, 117997

  • LLC Medical Center /ID# 169516

    Novosibirsk, Novosibirsk Oblast, 630099

  • Perm Regional Clinical Hospital /ID# 207642

    Perm, 614990

  • Nort-Western State Medical University n.a. Mechnikov /ID# 207641

    Saint Petersburg, Sankt-Peterburg, 193015

  • Ulyanovsk Regional Clinical Hospital /ID# 169515

    Ulyanovsk, 432017

Other trials in Russia

Spain8 sites

  • Hospital Universitario A Coruna - CHUAC /ID# 207826

    A Coruña, 15006

  • Hospital Universitario Torrecardenas /ID# 212716

    Almería, 04009

  • Hospital Universitario Germans Trias i Pujol /ID# 208543

    Badalona, Barcelona, 08916

  • Hospital Parc de Salut del Mar /ID# 209698

    Barcelona, 08003

  • Hospital Clinico Universitario San Carlos /ID# 207832

    Madrid, 28040

  • Hospital Universitario 12 de Octubre /ID# 207827

    Madrid, 28041

  • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207830

    Sabadell, Barcelona, 08208

  • Hospital Universitario y Politecnico La Fe /ID# 207831

    Valencia, 46026

Other trials in Spain

Australia7 sites

  • Flinders Medical Centre /ID# 210562

    Bedford Park, South Australia, 5042

  • Emeritus Research /ID# 207202

    Camberwell, Victoria, 3124

  • Monash Medical Centre /ID# 208034

    Clayton, Victoria, 3168

  • The Canberra Hospital /ID# 207592

    Garran, Australian Capital Territory, 2605

  • Royal Brisbane and Women's Hospital /ID# 212785

    Herston, Queensland, 4029

  • Rheumatology Research Unit Sunshine Coast /ID# 207200

    Maroochydore, Queensland, 4558

  • Griffith University /ID# 207505

    Southport, Queensland, 4222

Other trials in Australia

Canada7 sites

  • SKIN Centre for Dermatology /ID# 169604

    Peterborough, Ontario, K9J 5K2

  • Groupe de Recherche en Maladies Osseuses Inc /ID# 169598

    Sainte-Foy, Quebec, G1V 3M7

  • Dr. Latha Naik /ID# 212188

    Saskatoon, Saskatchewan, S7K 3H3

  • Percuro Clinical Research, Ltd /ID# 169601

    Victoria, British Columbia, V8V 3M9

  • K. Papp Clinical Research /ID# 169603

    Waterloo, Ontario, N2J 1C4

  • Manitoba Clinic /ID# 206819

    Winnipeg, Manitoba, R3A 1M3

  • CIADS Research Co Ltd /ID# 169600

    Winnipeg, Manitoba, R3N 0K6

Other trials in Canada

Croatia7 sites

  • UHC Osijek /ID# 208623

    Osijek, County of Osijek-Baranja, 31000

  • Klinicki bolnicki centar Rijeka /ID# 208621

    Rijeka, Primorje-Gorski Kotar County, 51000

  • Klinicki bolnicki centar Split /ID# 208626

    Split, Split-Dalmatia County, 21000

  • Poliklinika Repromed /ID# 208628

    Zagreb, City of Zagreb, 10000

  • Poliklinika Solmed /ID# 210965

    Zagreb, City of Zagreb, 10000

  • Medical Center Kuna-Peric /ID# 208047

    Zagreb, 10000

  • Poliklinika Bonifarm /ID# 208750

    Zagreb, 10000

Other trials in Croatia

Serbia7 sites

  • Institute for Rheumatology /ID# 168194

    Belgrade, Beograd, 11000

  • Institute for Rheumatology /ID# 168197

    Belgrade, Beograd, 11000

  • Institute for Rheumatology /ID# 168198

    Belgrade, Beograd, 11000

  • Institute for Rheumatology /ID# 168199

    Belgrade, Beograd, 11000

  • Military Medical Academy /ID# 168218

    Belgrade, Beograd, 11000

  • Special Hospital for Rheuma /ID# 168255

    Novi Sad, Vojvodina, 21000

  • Special Hospital for Rheuma /ID# 210284

    Novi Sad, Vojvodina, 21000

Other trials in Serbia

United Kingdom7 sites

  • NHS Greater Glasgow and Clyde /ID# 214942

    Glasgow, Scotland, G12 0XH

  • Duplicate_Barts Health NHS Trust /ID# 210534

    London, London, City of, E11 1NR

  • Manchester University NHS Foundation Trust /ID# 207928

    Manchester, M13 9WL

  • Duplicate_Wirral University Teaching Hospital NHS Foundation Trust /ID# 210535

    Metropolitan Borough of Wirral, CH49 5PE

  • Portsmouth Hospitals University NHS Trust /ID# 207932

    Portsmouth, PO6 3LY

  • Midlands Partnership NHS Foundation Trust /ID# 214941

    Stafford, Staffordshire, ST16 3SR

  • Torbay and South Devon Nhs Foundation Trust /Id# 207931

    Torquay, TQ2 7AA

Other trials in United Kingdom

Mexico6 sites

  • Centro Peninsular de Investigación Clínica SCP /ID# 208345

    Colonia Centro, Yucatán, 97000

  • Centro Integral en Reumatologia S.A de C.V /ID# 208346

    Guadalajara, Jalisco, 44160

  • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 208331

    Mexico City, Mexico City, 11850

  • Hospital General Regional No. 1 Dr. Carlos Mac Gregor Sánchez Navarro /ID# 210835

    Mexico City, 03100

  • RM Pharma Specialists S.A de C.V /ID# 208330

    Mexico City, 03100

  • Eukarya PharmaSite, SC /ID# 208431

    Monterrey, Nuevo León, 64718

Other trials in Mexico

Portugal6 sites

  • Centro Hospitalar do Baixo Vouga /ID# 215979

    Aveiro, 3810-164

  • CCA Braga - Hospital de Braga /ID# 208146

    Braga, 4710-243

  • Instituto Português De Reumatologia /ID# 208149

    Lisbon, 1050-034

  • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 208148

    Lisbon, 1649-035

  • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 208147

    Ponte de Lima, Viana do Castelo District, 4990-041

  • Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 208145

    Vila Nova de Gaia, Porto District, 4434-502

Other trials in Portugal

South Africa6 sites

  • Arthritis Clinical Research Trials /ID# 167625

    Cape Town, Western Cape, 7405

  • Dr Jenny Potts /ID# 168691

    Port Elizabeth, Eastern Cape, 6405

  • University of Pretoria /ID# 167621

    Pretoria, Gauteng, 0001

  • Dr Elsa van Duuren /ID# 207577

    Pretoria, Gauteng, 0002

  • Synexus Helderberg Clinical Research Centre /ID# 210891

    Somerset West, Western Cape, 7130

  • Winelands Medical Research Centre /ID# 167629

    Stellenbosch, Western Cape, 7600

Other trials in South Africa

Sweden6 sites

  • Falu Lasarett /ID# 210322

    Falun, 791 31

  • Skane University hospital /ID# 210070

    Malmö, Skåne County, 214 28

  • Orebro Universitetssjukhuset /ID# 207948

    Örebro, Örebro County, 701 85

  • Duplicate_Karolinska Univ Sjukhuset /ID# 208175

    Solna, 171 64

  • Uppsala University Hospital /ID# 207944

    Uppsala, 75185

  • Duplicate_Vastmanlands Sjukhus /ID# 207943

    Västerås, 723 35

Other trials in Sweden

Brazil5 sites

  • EDUMED Educacao em Saude S/S L /ID# 207488

    Curitiba, Paraná, 80440-080

  • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 207496

    Juiz de Fora, Minas Gerais, 36010-570

  • LMK Sevicos Medicos S/S /ID# 207491

    Porto Alegre, Rio Grande do Sul, 90480-000

  • SER - Serviços Especializados em Reumatologia /ID# 207489

    Salvador, Estado de Bahia, 40150-150

  • CPCLIN - Centro de Pesquisas Clínicas /ID# 207493

    São Paulo, 01228-200

Other trials in Brazil

Czechia5 sites

  • Revmacentrum MUDr. Mostera, s.r.o. /ID# 209025

    Brno, 615 00

  • PV MEDICAL Services s.r.o. /ID# 210222

    Prague, 130 00

  • MUDr. Zuzana Stejfova - revmatologicka ambulance /ID# 209027

    Prague, 140 00

  • Affidea Praha s.r.o. /ID# 210223

    Prague, 148 00

  • MEDICAL PLUS, s.r.o. /ID# 210439

    Uherské Hradiště, 686 01

Other trials in Czechia

Greece5 sites

  • General Hospital Asklepieio Voulas /ID# 212956

    Athens, Attica, 16673

  • Naval Hospital of Athens /ID# 206838

    Athens, 11521

  • 424 General MILITARY Hospital /ID# 210974

    Efkarpia (Thessalonikis), Thessaloniki, 56429

  • University General Hospital of Heraklion PA.G.N.I /ID# 206839

    Heraklion, Crete, 71500

  • Olympion General Clinic SA /ID# 207048

    Pátrai, 26443

Other trials in Greece

Israel5 sites

  • Barzilai Medical Center /ID# 207476

    Ashkelon, 7830604

  • Rambam Health Care Campus /ID# 208170

    Haifa, 3109601

  • Meir Medical Center /ID# 207473

    Kfar Saba, 4428164

  • Rabin Medical Center /ID# 207475

    Petah Tikva, 4941492

  • Sheba Medical Center /ID# 207474

    Ramat Gan, Tel Aviv, 5239424

Other trials in Israel

Italy5 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 207269

    Ancona, 60126

  • A.O.U. Policlinico G. Rodolico S.Marco - Presidio San Marco /ID# 207795

    Catania, 95124

  • Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207799

    Modena, Emilia-Romagna, 41124

  • Duplicate_Policlinico Univ Tor Vergata /ID# 207271

    Rome, 00133

  • Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 207265

    Verona, 37134

Other trials in Italy

Latvia5 sites

  • M & M Centrs LTD /ID# 208733

    Adazi, LV-2164

  • D.Saulites-Kandevicas PP in Cardiology and Rheumatology /ID# 207224

    Liepāja, LV-3401

  • Pauls Stradins Clinical University Hospital /ID# 207220

    Riga, 1002

  • Clinic ORTO /ID# 216218

    Riga, LV-1005

  • Riga East Clinical University Hospital /ID# 207223

    Riga, LV-1079

Other trials in Latvia

Slovakia5 sites

  • REUMA-GLOBAL, s.r.o. /ID# 208017

    Biely Kostol, 919 34

  • MEDMAN s.r.o. /ID# 208018

    Martin, 036 01

  • Reum.hapi s.r.o. /ID# 208016

    Nové Mesto nad Váhom, 915 01

  • Thermium s.r.o. /ID# 208015

    Piešťany, 921 01

  • REUMAMED POPRAD s.r.o. /ID# 208407

    Poprad, 058 01

Other trials in Slovakia

Bosnia and Herzegovina4 sites

  • University Clinical Centre of the Republic of Srpska /ID# 208268

    Banja Luka, Republika Srpska, 78000

  • University Clinical Centre of the Republic of Srpska /ID# 208269

    Banja Luka, Republika Srpska, 78000

  • University Clinical Centre of the Republic of Srpska /ID# 210047

    Banja Luka, Republika Srpska, 78000

  • Clinical Center University of Sarajevo /ID# 208272

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Bulgaria4 sites

  • Medical center Medconsult /ID# 211399

    Pleven, 5800

  • Medical center Excelsior /ID# 167741

    Sofia, 1407

  • Diagnostic consultative center 17 Sofia /ID# 210506

    Sofia, 1505

  • Military Medical Academy Multiprofile Hospital /ID# 210829

    Sofia, 1606

Other trials in Bulgaria

Germany4 sites

  • Immanuel Krankenhaus Berlin /ID# 207218

    Buch, 13125

  • Center of Innovative Diagnostics and Therapeutics (CIRI GmbH) /ID# 209483

    Frankfurt, 60590

  • MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 209484

    Hamburg, 20095

  • Rheumazentrum Ruhrgebiet /ID# 207216

    Herne, North Rhine-Westphalia, 44649

Other trials in Germany

Lithuania4 sites

  • VAKK Dr. Kilda's Clinic /ID# 207330

    Kaunas, 50128

  • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207331

    Kaunas, 50161

  • Klaipeda University Hospital /ID# 207329

    Klaipėda, 92288

  • Republican Siauliai hospital /ID# 207328

    Šiauliai, 76231

Other trials in Lithuania

Malaysia4 sites

  • Hospital Selayang /ID# 208938

    Batu Caves, Selangor, 68100

  • Hospital Raja Permaisuri Bainun /ID# 207920

    Ipoh, Perak, 30450

  • University Malaya Med Ctr /ID# 208937

    Kuala Lumpur, 59100

  • Hospital Tuanku Jaafar /ID# 207919

    Seremban, Negeri Sembilan, 70300

Other trials in Malaysia

Romania4 sites

  • Spitalul Clinic Sf. Maria /ID# 210054

    Bucharest, 011172

  • Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 207340

    Cluj-Napoca, 400006

  • Spitalul Clinic de Recuperare Iasi /ID# 207371

    Iași, 700661

  • Cabinet Medical Dr Triff Carina /Id# 207528

    Timișoara, Timiș County, 300766

Other trials in Romania

Belgium3 sites

  • ReumaClinic /ID# 208213

    Genk, 3600

  • Duplicate_UZ Ghent /ID# 210036

    Ghent, Oost-Vlaanderen, 9000

  • ZNA - Jan Palfijn /ID# 208212

    Merksem, 2170

Other trials in Belgium

Chile3 sites

  • CTR Estudios Clinicos /ID# 208166

    Providencia, 7500571

  • Centro Internacional de Estudios Clinicos /ID# 209908

    Santiago, 8420383

  • Clinica Dermacross S.A /ID# 208163

    Vitacura Santiago, 7640881

Other trials in Chile

Estonia3 sites

  • North Estonia Medical Centre /ID# 208325

    Mustamäe, Harju, 13419

  • Innomedica /ID# 211416

    Tallinn, Harju, 10117

  • MediTrials /ID# 207816

    Tartu, Tartu, 50708

Other trials in Estonia

Finland3 sites

  • Helsinki University Hospital /ID# 207724

    Helsinki, Uusimaa, 00290

  • Ite Pihlajanlinna Kuopio /ID# 208322

    Kuopio, 70100

  • Turku University Hospital /ID# 207726

    Turku, 20520

Other trials in Finland

Netherlands3 sites

  • Universitair Medisch Centrum Groningen /ID# 208580

    Groningen, 9713 GZ

  • Medisch Centrum Leeuwarden /ID# 168453

    Leeuwarden, 8934 AD

  • Antonius Ziekenhuis /ID# 208587

    Sneek, Provincie Friesland, 8601 ZK

Other trials in Netherlands

New Zealand3 sites

  • CGM Research Trust /ID# 210498

    Burwood, 8083

  • Waikato Hospital /ID# 213257

    Hamilton, Waikato Region, 3240

  • Middlemore Clinical Trials /ID# 213256

    Papatoetoe, Auckland, 2025

Other trials in New Zealand

Singapore3 sites

  • National University Hospital /ID# 208599

    Singapore, 119074

  • Singapore General Hospital /ID# 207917

    Singapore, 169608

  • Changi General Hospital /ID# 208965

    Singapore, 529889

Other trials in Singapore

South Korea3 sites

  • Kyungpook National Univ Hosp /ID# 207408

    Daegu, 41944

  • Hanyang University Seoul Hospital /ID# 209263

    Seoul, Seoul Teugbyeolsi, 04763

  • Duplicate_Konkuk University Medical Ctr /ID# 207509

    Seoul, Seoul Teugbyeolsi, 05030

Other trials in South Korea

Taiwan3 sites

  • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 207567

    Chiayi City, 62247

  • Chung Shan Medical University Hospital /ID# 207257

    Taichung, 40201

  • Linkou Chang Gung Memorial Ho /ID# 207255

    Taoyuan City, 333

Other trials in Taiwan

Denmark2 sites

  • Aarhus University Hospital /ID# 168761

    Aarhus C, Central Jutland, 8000

  • Bispebjerg and Frederiksberg Hospital /ID# 207576

    Frederiksberg, Capital Region, 2000

Other trials in Denmark

Puerto Rico1 site

  • Mindful Medical Research /ID# 211129

    San Juan, 00918-3756

Other trials in Puerto Rico

About this study

Official title: A Phase 3, Randomized, Double-Blind, Study Comparing Risankizumab to Placebo in Subjects With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1)

The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in participants with moderately to severely active psoriatic arthritis (PsA).

Read the detailed description

The study consists of a Screening Period (approximately 35 days), Period 1, Period 2, and a 20-week Follow-up Period. Period 1 is a 24-week randomized, double-blind, placebo-controlled, parallel-group treatment period. Period 2 is the long-term treatment period and starts at Week 24. To maintain the blind to the original treatment allocation, treatment at the Week 24 Visit is blinded: participants randomized to placebo receive blinded risankizumab 150 mg, and participants randomized to risankizumab receive blinded placebo. At Week 28 and for the remaining dosing visits (to Week 316), all participants are to receive open-label risankizumab 150 mg every 12 weeks. Participants will remain blinded to the original randomization allocation for the duration of the study. The total study duration is 336 weeks including a telephone call 140 days (20 weeks) after last dose of study drug.

Being tested
Placebo, Risankizumab
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboBiological

    Placebo for risankizumab administered by subcutaneous injection

  • RisankizumabBiological

    Also called ABBV-066, BI 655066, SKYRIZI

    Risankizumab administered by subcutaneous injection

Study groups in NCT03675308
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants 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.
Receives: Biological: Placebo; Biological: Risankizumab
RisankizumabExperimentalParticipants 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.
Receives: Biological: Placebo; Biological: Risankizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24

    Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:

    1. ≥ 20% improvement in 68-tender joint count;
    2. ≥ 20% improvement in 66-swollen joint count; and
    3. ≥ 20% improvement in at least 3 of the 5 following parameters:
    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).

    Measured: Baseline and Week 24

Secondary outcomes (13)

  1. Change From Baseline In Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24

    The Health Assessment Questionnaire Disability Index is a patient-reported questionnaire that measures the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores) over the past week. Participants assessed their ability to do each task on a scale from 0 (without any difficulty) to 3 (unable to do). Scores were averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 represents very severe, high-dependency disability.

    A negative change from Baseline in the overall score indicates improvement.

    Measured: Baseline and Week 24

  2. Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24

    PASI is a composite score based on the percentage of the body surface area (BSA) affected by psoriasis and the intensity of erythema (reddening), induration (thickening or hardening of the skin), and desquamation (peeling of the skin) of lesions assessed at 4 anatomic sites (head, upper extremities, trunk, and lower extremities). At each location, the percentage of BSA involvement is assigned a score from 0 (no involvement) to 6 (90% to 100% involvement), and erythema, induration, and desquamation are scored on a scale from 0 (no symptoms) to 4 (very marked).

    The PASI score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). A PASI 90 response is the percentage of participants who achieved at least a 90% reduction (improvement) from Baseline in PASI score.

    Measured: Baseline and Week 24

  3. Percentage of Participants With an ACR20 Response at Week 16

    Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR20 response criteria:

    1. ≥ 20% improvement in 68-tender joint count;
    2. ≥ 20% improvement in 66-swollen joint count; and
    3. ≥ 20% improvement in at least 3 of the 5 following parameters:
    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).

    Measured: Baseline and Week 16

  4. Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24

    A participant was classified as achieving MDA if 5 of the following 7 criteria were met:

    • Tender joint count (out of 68 joints) ≤ 1
    • Swollen joint count (out of 66 joints) ≤ 1
    • PASI score ≤ 1 (score ranges from 0 - 72) or percent BSA involved with psoriasis ≤ 3%
    • Patient's assessment of pain ≤ 15 (VAS from 0 to 100)
    • Patient's Global Assessment of disease activity ≤ 20 (VAS from 0 to 100)
    • HAQ-DI score ≤ 0.5 (index score ranges from 0 to 3)
    • Leeds Enthesitis Index ≤ 1 (assesses the presence or absence of enthesitis at 3 bilateral sites, for an overall score range from 0 to 6)

    Measured: Week 24

  5. Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 24

    The investigator assessed each fingernail for onycholysis (separation of the nail plate from the nail bed) and oil-drop (salmon patch) dyschromia (reddish-brown discoloration under the nail plate) on a scale of 0 (none present) to 3 (>30% of the nail), pitting (small, sharply defined depressions in the nail surface) on a scale of 0 (0 pits present) to 3 (> 50 pits present), and nail plate crumbling on a scale of 0 (no crumbling) to 3 (>50% of nail has crumbling) and presence (1) or absence (0) of leukonychia (white spots), splinter hemorrhages, nail bed hyperkeratosis, and red spots in the lunula.

    The mNAPSI score is calculated as the sum of all the components for all of the participant's fingernails giving a range of possible scores from 0 (absence of nail psoriasis) to 130 (the most severe nail psoriasis). A negative change from Baseline indicates improvement.

    Measured: Baseline and Week 24

  6. Change From Baseline in Fingernail-Physician Global Assessment (PGA-F)

    The PGA-F is a clinician-rated outcomes assessment used to measure the severity of signs and symptoms associated with fingernail psoriasis. Participant's fingernails were assessed separately for nail bed signs and nail matrix signs of disease on a scale from 0 (clear) to 4 (severe). A participant's overall global score is the worse of the nail bed score and nail matrix score. For example, if a participant had a nail bed score '2' and a nail matrix score of '4,' this participant's overall score was '4.' A negative change from Baseline indicates improvement.

    Measured: Baseline and Week 24

  7. Percentage of Participants With Resolution of Enthesitis at Week 24

    Resolution of enthesitis is defined as a Leeds Enthesitis Index (LEI) score = 0.

    LEI is an enthesitis measure developed specifically for PsA and assesses the presence or absence of tenderness at the following 3 bilateral enthesial sites: medial femoral condyles, lateral epicondyles of the humerus, and Achilles tendon insertions. Tenderness on examination is recorded as either present (coded as 1), absent (coded as 0), or not assessed for each of the 6 sites. The LEI is calculated by taking the sum of the scores from the 6 sites. The LEI ranges from 0 to 6 (worst).

    To increase the sample size due to the smaller number of participants with enthesitis at Baseline, the pre-specified analysis of the resolution of enthesitis included pooled data from KEEPsAKE 1 (this study) and the companion study KEEPsAKE 2 (M15-998; NCT03671148).

    Measured: Week 24

  8. Percentage of Participants With Resolution of Dactylitis at Week 24

    Resolution of dactylitis is defined as a Leeds Dactylitis Index (LDI) score = 0.

    LDI basic is a score based on finger circumference and tenderness, assessed across all digits. The LDI basic measures the ratio of the circumference of the affected digit to the circumference of the digit on the opposite hand or foot, using a minimum difference of 10% to define a dactylitic digit. The ratio of circumference is multiplied by a tenderness score (1 for tender, 0 for non-tender). If both sides of a digit are considered involved, or the circumference of the contralateral digit cannot be obtained, a standard reference table is used. Scores from each digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis.

    To increase sample size due to the smaller number of participants with dactylitis at Baseline, the pre-specified analysis of the resolution of dactylitis included pooled data from KEEPsAKE 1 (this study) and the companion study KEEPsAKE 2 (M15-998; NCT03671148).

    Measured: Week 24

  9. Change From Baseline in PsA Modified Total Sharp Score (mTSS) at Week 24

    The Sharp-van der Heijde modified scoring method for PsA measures the level of joint damage from radiographs of the hands and feet, and was assessed by 2 independent, blinded readers.

    Joint erosion severity was assessed in 20 joints in each hand and wrist and 6 joints in each foot. Each joint was scored from 0 (no erosion) to 5 for hands/wrists or to 10 for feet (complete collapse). The total erosion score ranges from 0 to 320 (worst).

    Joint space narrowing (JSN) was assessed in 20 joints of each hand and wrist, and 6 joints of each foot, from 0 (normal) to 4 (complete loss of joint space, bony ankylosis, or luxation). The total JSN score ranges from 0 to 208 (worst).

    Joints with gross osteolysis or pencil in cup were assigned the maximum score for both erosions and JSN.

    The total mTSS score is the sum of the joint erosion and JSN scores and ranges from 0 (normal) to 528 (worst).

    Measured: Baseline and Week 24

  10. Change From Baseline In 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24

    The Short Form 36-Item Health Survey (SF-36) Version 2 is a self-administered questionnaire that measures the impact of disease on overall quality of life during the past 4 weeks. The SF-36 consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health).

    The physical component summary is a weighted combination of the 8 subscales with positive weighting for physical functioning, role-physical, bodily pain, and general health. The SF-36 PCS ranges from 0 to 100. A linear algorithm was applied to the calculation of the PCS which has a normative mean value of 50. Higher scores are associated with less disability; a score of 100 is equivalent to no disability and a score of 0 is equivalent to maximum disability. A positive change from Baseline score indicates improvement.

    Measured: Baseline and Week 24

  11. Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24

    The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 (not at all) to 4 (very much).

    The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue.

    A positive change from Baseline indicates improvement.

    Measured: Baseline and Week 24

  12. Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24

    Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR50 response criteria:

    1. ≥ 50% improvement in 68-tender joint count;
    2. ≥ 50% improvement in 66-swollen joint count; and
    3. ≥ 50% improvement in at least 3 of the 5 following parameters:
    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).

    Measured: Baseline and Week 24

  13. Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24

    Participants who met the following 3 conditions for improvement from Baseline were classified as meeting the ACR70 response criteria:

    1. ≥ 70% improvement in 68-tender joint count;
    2. ≥ 70% improvement in 66-swollen joint count; and
    3. ≥ 70% improvement in at least 3 of the 5 following parameters:
    • Physician global assessment of disease activity
    • Patient global assessment of disease activity
    • Patient assessment of pain
    • Health Assessment Questionnaire - Disability Index (HAQ-DI)
    • High-sensitivity C-reactive protein (hsCRP).

    Measured: Baseline and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2018
  2. Study start25 Mar 2019
  3. Primary completion8 Oct 2020
  4. Study completion28 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
964 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03675308
Sponsor's protocol ID
M16-011
Other IDs
2017-002465-22, 2017
Acronym
KEEPsAKE 1
Status last verified
Aug 2025
First submitted
12 Sep 2018
Last updated
5 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Publications

  • Kristensen LE, Keiserman M, Papp K, McCasland L, White D, Lu W, Wang Z, Soliman AM, Eldred A, Barcomb L, Behrens F. Efficacy and safety of risankizumab for active psoriatic arthritis: 24-week results from the randomised, double-blind, phase 3 KEEPsAKE 1 trial. Ann Rheum Dis. 2022 Feb;81(2):225-231. doi: 10.1136/annrheumdis-2021-221019. Epub 2021 Dec 15.

    PubMed 34911706

  • Gossec L, Balanescu A, D'Agostino MA, Ogdie A, Sewerin P, Deng Y, Shi L, Sugimoto Y, Zhong S, Xing Y, Lippe R, Kishimoto M. Efficacy of Risankizumab across distinct PsA phenotypes identified with machine learning analytics using data from biologic DMARD-Naive patients in two phase 3 clinical trials. Arthritis Res Ther. 2025 Nov 29;28(1):2. doi: 10.1186/s13075-025-03670-0.

    PubMed 41318485

  • Ostor A, Van den Bosch F, Papp K, Keiserman M, Blanco R, Crowley A, White D, Biljan A, Madihlaba T, Carter K, Liu F, Soliman AM, Ashley D, Chen M, Glotfelty L, Kivitz A. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 196-Week Results from the KEEPsAKE 1 and KEEPsAKE 2 Randomized Clinical Trials. Rheumatol Ther. 2025 Dec;12(6):1103-1123. doi: 10.1007/s40744-025-00793-3. Epub 2025 Sep 30.

    PubMed 41028616

  • Mease PJ, Warren RB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, McInnes IB. Comparative Effectiveness of Bimekizumab and Risankizumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Oct;11(5):1403-1412. doi: 10.1007/s40744-024-00706-w. Epub 2024 Aug 9.

    PubMed 39120849

  • Kwatra SG, Khattri S, Amin AZ, Ranza R, Kaplan B, Shi L, Padilla B, Soliman AM, McGonagle D. Enthesitis and Dactylitis Resolution with Risankizumab for Active Psoriatic Arthritis: Integrated Analysis of the Randomized KEEPsAKE 1 and 2 Trials. Dermatol Ther (Heidelb). 2024 Jun;14(6):1517-1530. doi: 10.1007/s13555-024-01174-4. Epub 2024 May 13.

    PubMed 38739215

  • Kristensen LE, Keiserman M, Papp K, McCasland L, White D, Carter K, Lippe R, Photowala H, Drogaris L, Soliman AM, Chen M, Padilla B, Behrens F. Efficacy and Safety of Risankizumab for Active Psoriatic Arthritis: 100-Week Results from the Phase 3 KEEPsAKE 1 Randomized Clinical Trial. Rheumatol Ther. 2024 Jun;11(3):617-632. doi: 10.1007/s40744-024-00654-5. Epub 2024 Mar 18.

    PubMed 38498141

  • Kristensen LE, Keiserman M, Papp K, McCasland L, White D, Lu W, Soliman AM, Eldred A, Barcomb L, Behrens F. Efficacy and safety of risankizumab for active psoriatic arthritis: 52-week results from the KEEPsAKE 1 study. Rheumatology (Oxford). 2023 Jun 1;62(6):2113-2121. doi: 10.1093/rheumatology/keac607.

    PubMed 36282530

  • Thakre N, D'Cunha R, Goebel A, Liu W, Pang Y, Suleiman AA. Population Pharmacokinetics and Exposure-Response Analyses for Risankizumab in Patients with Active Psoriatic Arthritis. Rheumatol Ther. 2022 Dec;9(6):1587-1603. doi: 10.1007/s40744-022-00495-0. Epub 2022 Sep 30.

    PubMed 36178584

  • Kristensen LE, Soliman AM, Papp K, White D, Barcomb L, Lu W, Eldred A, Behrens F. Risankizumab improved health-related quality of life, fatigue, pain and work productivity in psoriatic arthritis: results of KEEPsAKE 1. Rheumatology (Oxford). 2023 Feb 1;62(2):629-637. doi: 10.1093/rheumatology/keac342.

    PubMed 35801915

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Risankizumab in people with Psoriatic Arthritis, run by AbbVie at 256 sites in 39 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 256 sites in United States, Argentina, Ukraine, Poland, Russia and 34 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03675308, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.

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