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 (KEEPsAKE 1)

April 14, 2023 updated by: AbbVie

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).

Study Overview

Status

Active, not recruiting

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

964

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, 2201
        • Duplicate_Inst de Rehab Psicofisica /ID# 214681
      • Cordoba, Argentina, 5016
        • Duplicate_Hospital Privado Univesitario /ID# 211623
      • San Miguel de Tucuman, Argentina, 4000
        • Cimer /Id# 169167
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, 1902
        • Framingham Centro Medico /ID# 210409
    • Ciuadad Autonoma De Buenos Aires
      • Buenos Aires, Ciuadad Autonoma De Buenos Aires, Argentina, 1221
        • Hospital General de Agudos J. M. Ramos Mejia /ID# 169164
      • Ciudad Autonoma Buenos Aires, Ciuadad Autonoma De Buenos Aires, Argentina, 1199
        • Hospital Italiano de Buenos Aires /ID# 208474
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1111
        • DOM Centro de Reumatologia /ID# 208479
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1121
        • Fundacion CIDEA /ID# 210494
      • Ciudad Autonoma de Buenos Aire, Ciuadad Autonoma De Buenos Aires, Argentina, 1426
        • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 211622
    • Santa Fe
      • Rosario, Santa Fe, Argentina, 2000
        • Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 169163
      • Rosario, Santa Fe, Argentina, 2000
        • Instituto CAICI /ID# 169168
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • Centro Medico Privado de Reumatologia /ID# 208343
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • The Canberra Hospital /ID# 207592
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital /ID# 212785
      • Maroochydore, Queensland, Australia, 4558
        • Rheumatology Research Unit Sunshine Coast /ID# 207200
      • Southport, Queensland, Australia, 4222
        • Griffith University /ID# 207505
    • South Australia
      • Bedford, Park, South Australia, Australia, 5042
        • Flinders Medical Centre /ID# 210562
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research /ID# 207202
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre /ID# 208034
      • Genk, Belgium, 3600
        • ReumaClinic /ID# 208213
      • Merksem, Belgium, 2170
        • ZNA - Jan Palfijn /ID# 208212
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgium, 9000
        • Duplicate_UZ Ghent /ID# 210036
      • Sarajevo, Bosnia and Herzegovina, 71000
        • Clinical Center University of Sarajevo /ID# 208272
    • Republika Srpska
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 208268
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 208269
      • Banja Luka, Republika Srpska, Bosnia and Herzegovina, 78000
        • University Clinical Centre of the Republic of Srpska /ID# 210047
      • Sao Paulo, Brazil, 01228-200
        • CPCLIN - Centro de Pesquisas Clínicas /ID# 207493
    • Bahia
      • Salvador, Bahia, Brazil, 40150-150
        • SER - Serviços Especializados em Reumatologia /ID# 207489
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Brazil, 36010-570
        • CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 207496
    • Parana
      • Curitiba, Parana, Brazil, 80440-080
        • EDUMED Educacao em Saude S/S L /ID# 207488
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90480-000
        • LMK Sevicos Medicos S/S /ID# 207491
      • Pleven, Bulgaria, 5800
        • Medical center Medconsult /ID# 211399
      • Sofia, Bulgaria, 1407
        • Medical center Excelsior /ID# 167741
      • Sofia, Bulgaria, 1505
        • Diagnostic consultative center 17 Sofia /ID# 210506
      • Sofia, Bulgaria, 1606
        • Military Medical Academy Multiprofile Hospital /ID# 210829
    • British Columbia
      • Victoria, British Columbia, Canada, V8V 3M9
        • Percuro Clinical Research, Ltd /ID# 169601
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Manitoba Clinic /ID# 206819
      • Winnipeg, Manitoba, Canada, R3N 0K6
        • CIADS Research Co Ltd /ID# 169600
    • Ontario
      • Peterborough, Ontario, Canada, K9J 5K2
        • SKIN Centre for Dermatology /ID# 169604
      • Waterloo, Ontario, Canada, N2J 1C4
        • K. Papp Clinical Research /ID# 169603
    • Quebec
      • Sainte-foy, Quebec, Canada, G1V 3M7
        • Groupe de Recherche en Maladies Osseuses Inc /ID# 169598
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 3H3
        • Dr. Latha Naik /ID# 212188
      • Providencia, Chile, 7500571
        • CTR Estudios Clinicos /ID# 208166
      • Santiago, Chile, 8420383
        • Centro Internacional de Estudios Clinicos /ID# 209908
      • Vitacura Santiago, Chile, 7640881
        • Clinica Dermacross S.A /ID# 208163
      • Zagreb, Croatia, 10000
        • Medical Center Kuna-Peric /ID# 208047
      • Zagreb, Croatia, 10000
        • Poliklinika Bonifarm /ID# 208750
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Poliklinika Repromed /ID# 208628
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Poliklinika Solmed /ID# 210965
    • Osjecko-baranjska Zupanija
      • Osijek, Osjecko-baranjska Zupanija, Croatia, 31000
        • UHC Osijek /ID# 208623
    • Primorsko-goranska Zupanija
      • Rijeka, Primorsko-goranska Zupanija, Croatia, 51000
        • Klinicki bolnicki centar Rijeka /ID# 208621
    • Splitsko-dalmatinska Zupanija
      • Split, Splitsko-dalmatinska Zupanija, Croatia, 21000
        • Klinicki bolnicki centar Split /ID# 208626
      • Brno, Czechia, 615 00
        • Revmacentrum MUDr. Mostera, s.r.o. /ID# 209025
      • Praha, Czechia, 130 00
        • PV MEDICAL Services s.r.o. /ID# 210222
      • Praha, Czechia, 140 00
        • MUDr. Zuzana Stejfova - revmatologicka ambulance /ID# 209027
      • Praha, Czechia, 148 00
        • Affidea Praha s.r.o. /ID# 210223
      • Uherske Hradiste, Czechia, 686 01
        • MEDICAL PLUS, s.r.o. /ID# 210439
    • Hovedstaden
      • Frederiksberg, Hovedstaden, Denmark, 2000
        • Bispebjerg and Frederiksberg Hospital /ID# 207576
    • Midtjylland
      • Aarhus C, Midtjylland, Denmark, 8000
        • Aarhus University Hospital /ID# 168761
    • Harjumaa
      • Mustamäe Linnaosa, Harjumaa, Estonia, 13419
        • North Estonia Medical Centre /ID# 208325
      • Tallinn, Harjumaa, Estonia, 10117
        • Innomedica /ID# 211416
    • Tartumaa
      • Tartu, Tartumaa, Estonia, 50708
        • MediTrials /ID# 207816
      • Kuopio, Finland, 70100
        • Ite Pihlajanlinna Kuopio /ID# 208322
      • Turku, Finland, 20520
        • Turku University Hospital /ID# 207726
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00290
        • Helsinki University Hospital /ID# 207724
      • Berlin-buch, Germany, 13125
        • Immanuel Krankenhaus Berlin /ID# 207218
      • Frankfurt, Germany, 60590
        • Center of Innovative Diagnostics and Therapeutics (CIRI GmbH) /ID# 209483
      • Hamburg, Germany, 20095
        • MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 209484
    • Nordrhein-Westfalen
      • Herne, Nordrhein-Westfalen, Germany, 44649
        • Rheumazentrum Ruhrgebiet /ID# 207216
      • Athens, Greece, 11521
        • Naval Hospital of Athens /ID# 206838
      • Patras, Greece, 26443
        • Olympion General Clinic SA /ID# 207048
    • Attiki
      • Athens, Attiki, Greece, 16673
        • General Hospital Asklepieio Voulas /ID# 212956
    • Kriti
      • Heraklion, Kriti, Greece, 71500
        • University General Hospital of Heraklion PA.G.N.I /ID# 206839
    • Thessaloniki
      • Efkarpia (Thessalonikis), Thessaloniki, Greece, 56429
        • 424 General MILITARY Hospital /ID# 210974
      • Ashkelon, Israel, 7830604
        • Barzilai Medical Center /ID# 207476
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus /ID# 208170
      • Kfar Saba, Israel, 4428164
        • Meir Medical Center /ID# 207473
      • Petakh Tikva, Israel, 4941492
        • Rabin Medical Center /ID# 207475
    • Tel-Aviv
      • Ramat Gan, Tel-Aviv, Israel, 5239424
        • Sheba Medical Center /ID# 207474
      • Ancona, Italy, 60126
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 207269
      • Catania, Italy, 95124
        • A.O.U. Policlinico G. Rodolico S.Marco - Presidio San Marco /ID# 207795
      • Rome, Italy, 00133
        • Duplicate_Policlinico Univ Tor Vergata /ID# 207271
      • Verona, Italy, 37134
        • Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 207265
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41124
        • Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207799
      • Daegu, Korea, Republic of, 41944
        • Kyungpook National Univ Hosp /ID# 207408
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 04763
        • Hanyang University Seoul Hospital /ID# 209263
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05030
        • Duplicate_Konkuk University Medical Ctr /ID# 207509
      • Adazi, Latvia, LV-2164
        • M & M Centrs LTD /ID# 208733
      • Liepaja, Latvia, LV-3401
        • D.Saulites-Kandevicas PP in Cardiology and Rheumatology /ID# 207224
      • Riga, Latvia, 1002
        • Pauls Stradins Clinical University Hospital /ID# 207220
      • Riga, Latvia, LV-1005
        • Clinic ORTO /ID# 216218
      • Riga, Latvia, LV-1079
        • Riga East Clinical University Hospital /ID# 207223
      • Kaunas, Lithuania, 50128
        • VAKK Dr. Kilda's Clinic /ID# 207330
      • Kaunas, Lithuania, 50161
        • Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207331
      • Klaipeda, Lithuania, 92288
        • Klaipeda University Hospital /ID# 207329
      • Siauliai, Lithuania, 76231
        • Republican Siauliai hospital /ID# 207328
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Med Ctr /ID# 208937
    • Negeri Sembilan
      • Seremban, Negeri Sembilan, Malaysia, 70300
        • Hospital Tuanku Jaafar /ID# 207919
    • Perak
      • Ipoh, Perak, Malaysia, 30450
        • Hospital Raja Permaisuri Bainun /ID# 207920
    • Selangor
      • Batu Caves, Selangor, Malaysia, 68100
        • Hospital Selayang /ID# 208938
      • Ciudad de Mexico, Mexico, 03100
        • Hospital General Regional No. 1 Dr. Carlos Mac Gregor Sánchez Navarro /ID# 210835
      • Mexico City, Mexico, 03100
        • RM Pharma Specialists S.A de C.V /ID# 208330
    • Ciudad De Mexico
      • Mexico City, Ciudad De Mexico, Mexico, 11850
        • CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 208331
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • Centro Integral en Reumatologia S.A de C.V /ID# 208346
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64718
        • Eukarya PharmaSite, SC /ID# 208431
    • Yucatan
      • Colonia Centro, Yucatan, Mexico, 97000
        • Centro Peninsular de Investigación Clínica SCP /ID# 208345
      • Groningen, Netherlands, 9713 GZ
        • Universitair Medisch Centrum Groningen /ID# 208580
      • Leeuwarden, Netherlands, 8934 AD
        • Medisch Centrum Leeuwarden /ID# 168453
    • Fryslan
      • Sneek, Fryslan, Netherlands, 8601 ZK
        • Antonius Ziekenhuis /ID# 208587
      • Burwood, New Zealand, 8083
        • CGM Research Trust /ID# 210498
    • Auckland
      • Papatoetoe, Auckland, New Zealand, 2025
        • Middlemore Clinical Trials /ID# 213256
    • Waikato
      • Hamilton, Waikato, New Zealand, 3240
        • Waikato Hospital /ID# 213257
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-605
        • Spolka Lekarzy INTERCOR /ID# 210191
      • Torun, Kujawsko-pomorskie, Poland, 87-100
        • Nasz Lekarz Przychodnie Medyczne /ID# 216176
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-149
        • Malopolskie Centrum Kliniczne /ID# 208007
    • Mazowieckie
      • Grodzisk Mazowiecki, Mazowieckie, Poland, 05-825
        • McBk Sc /Id# 209132
      • Warsaw, Mazowieckie, Poland, 02-691
        • Centrum Medyczne Reuma Park w Warszawie /ID# 210352
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-351
        • Osteo-Medic S.C. /ID# 208008
      • Bialystok, Podlaskie, Poland, 15-879
        • ClinicMed Daniluk, Nowak Sp.j. /ID# 210824
    • Warminsko-mazurskie
      • Elblag, Warminsko-mazurskie, Poland, 82-300
        • Centrum Kliniczno-Badawcze /ID# 208010
      • Olsztyn, Warminsko-mazurskie, Poland, 10-117
        • ETYKA-Osrodek Badan Klinicznych /ID# 216241
      • Aveiro, Portugal, 3810-164
        • Centro Hospitalar do Baixo Vouga /ID# 215979
      • Braga, Portugal, 4710-243
        • CCA Braga - Hospital de Braga /ID# 208146
      • Lisboa, Portugal, 1050-034
        • Instituto Português De Reumatologia /ID# 208149
      • Lisboa, Portugal, 1649-035
        • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 208148
    • Porto
      • Vila Nova De Gaia, Porto, Portugal, 4434-502
        • Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 208145
    • Viana Do Castelo
      • Ponte de Lima, Viana Do Castelo, Portugal, 4990-041
        • Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 208147
      • San Juan, Puerto Rico, 00918-3756
        • Mindful Medical Research /ID# 211129
      • Bucuresti, Romania, 011172
        • Spitalul Clinic Sf. Maria /ID# 210054
      • Cluj-Napoca, Romania, 400006
        • Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 207340
      • Iasi, Romania, 700661
        • Spitalul Clinic de Recuperare Iasi /ID# 207371
    • Timis
      • Timisoara, Timis, Romania, 300766
        • Cabinet Medical Dr Triff Carina /Id# 207528
      • Moscow, Russian Federation, 117997
        • Federal Center for Brain and Neurotechnology /ID# 207646
      • Perm, Russian Federation, 614990
        • Perm Regional Clinical Hospital /ID# 207642
      • Ulyanovsk, Russian Federation, 432017
        • Ulyanovsk Regional Clinical Hospital /ID# 169515
    • Moskva
      • Korolev, Moskva, Russian Federation, 141060
        • LLC Family Outpatient Clinic № /ID# 169510
      • Moscow, Moskva, Russian Federation, 115522
        • Research Institute of Rheumatology named after V.A. Nasonova /ID# 207643
    • Novosibirskaya Oblast
      • Novosibirsk, Novosibirskaya Oblast, Russian Federation, 630099
        • LLC Medical Center /ID# 169516
    • Sankt-Peterburg
      • St. Petersburg, Sankt-Peterburg, Russian Federation, 193015
        • Nort-Western State Medical University n.a. Mechnikov /ID# 207641
    • Tatarstan, Respublika
      • Kazan, Tatarstan, Respublika, Russian Federation, 420012
        • Kazan State Medical University /ID# 169511
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Institute for Rheumatology /ID# 168194
      • Belgrade, Beograd, Serbia, 11000
        • Institute for Rheumatology /ID# 168197
      • Belgrade, Beograd, Serbia, 11000
        • Institute for Rheumatology /ID# 168198
      • Belgrade, Beograd, Serbia, 11000
        • Institute for Rheumatology /ID# 168199
      • Belgrade, Beograd, Serbia, 11000
        • Military Medical Academy /ID# 168218
    • Vojvodina
      • Novi Sad, Vojvodina, Serbia, 21000
        • Special Hospital for Rheuma /ID# 168255
      • Novi Sad, Vojvodina, Serbia, 21000
        • Special Hospital for Rheuma /ID# 210284
      • Singapore, Singapore, 119074
        • National University Hospital /ID# 208599
      • Singapore, Singapore, 169608
        • Singapore General Hospital /ID# 207917
      • Singapore, Singapore, 529889
        • Changi General Hospital /ID# 208965
      • Biely Kostol, Slovakia, 919 34
        • REUMA-GLOBAL, s.r.o. /ID# 208017
      • Martin, Slovakia, 036 01
        • MEDMAN s.r.o. /ID# 208018
      • Nove Mesto nad Vahom, Slovakia, 915 01
        • Reum.hapi s.r.o. /ID# 208016
      • Piestany, Slovakia, 921 01
        • Thermium s.r.o. /ID# 208015
      • Poprad, Slovakia, 058 01
        • REUMAMED POPRAD s.r.o. /ID# 208407
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6405
        • Dr Jenny Potts /ID# 168691
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0001
        • University of Pretoria /ID# 167621
      • Pretoria, Gauteng, South Africa, 0002
        • Dr Elsa van Duuren /ID# 207577
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7405
        • Arthritis Clinical Research Trials /ID# 167625
      • Somerset West, Western Cape, South Africa, 7130
        • Synexus Helderberg Clinical Research Centre /ID# 210891
      • Stellenbosch, Western Cape, South Africa, 7600
        • Winelands Medical Research Centre /ID# 167629
      • A Coruna, Spain, 15006
        • Hospital Universitario A Coruna - CHUAC /ID# 207826
      • Almeria, Spain, 04009
        • Hospital Universitario Torrecardenas /ID# 212716
      • Barcelona, Spain, 08003
        • Hospital Parc de Salut del Mar /ID# 209698
      • Madrid, Spain, 28040
        • Hospital Clinico Universitario San Carlos /ID# 207832
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre /ID# 207827
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico La Fe /ID# 207831
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol /ID# 208543
      • Sabadell, Barcelona, Spain, 08208
        • Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207830
      • Falun, Sweden, 791 31
        • Falu Lasarett /ID# 210322
      • Solna, Sweden, 171 64
        • Duplicate_Karolinska Univ Sjukhuset /ID# 208175
      • Uppsala, Sweden, 75185
        • Uppsala University Hospital /ID# 207944
      • Vasteras, Sweden, 723 35
        • Duplicate_Vastmanlands Sjukhus /ID# 207943
    • Orebro Lan
      • Orebro, Orebro Lan, Sweden, 701 85
        • Orebro Universitetssjukhuset /ID# 207948
    • Skane Lan
      • Malmo, Skane Lan, Sweden, 214 28
        • Skane University hospital /ID# 210070
      • Chia-Yi, Taiwan, 62247
        • Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 207567
      • Taichung, Taiwan, 40201
        • Chung Shan Medical University Hospital /ID# 207257
      • Taoyuan City, Taiwan, 333
        • Linkou Chang Gung Memorial Ho /ID# 207255
      • Cherkasy, Ukraine, 18009
        • CNE Cherkasy Regional Hospital of Cherkasy Regional Council /ID# 207912
      • Chernihiv, Ukraine, 14029
        • MNPE Chernihiv Regional Hospital of the Chernihiv Region Council /ID# 207730
      • Kharkiv, Ukraine, 61029
        • PNE City Multifunctional Hospital No.18 /ID# 207911
      • Khmelnytskyi, Ukraine, 29000
        • Khmelnytskyi Regional Hospital /ID# 207753
      • Kryvyi Rih, Ukraine, 50056
        • MI Kryvyi Rih City Clinical Hospital No.2 /ID# 207748
      • Kyiv, Ukraine, 02091
        • Medical Center OK Clinic /ID# 207749
      • Lutsk, Ukraine, 43005
        • Communal Enterprise Volyn Regional Clinical hospital of the Volyn Regional Coun /ID# 208276
      • Lviv, Ukraine, 79011
        • Lviv Municipal City Clinical Hospital #4 /ID# 207715
      • Poltava, Ukraine, 36011
        • PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 207872
      • Zaporizhzhia, Ukraine, 69035
        • Public Institution 6th City Clinical Hospital /ID# 207754
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61039
        • State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 209556
    • Vinnytska Oblast
      • Vinnytsia, Vinnytska Oblast, Ukraine, 21029
        • Scientific Research Institute of Invalid Rehabilitation /ID# 207873
      • Manchester, United Kingdom, M13 9WL
        • Manchester University NHS Foundation Trust /ID# 207928
      • Portsmouth, United Kingdom, PO6 3LY
        • Portsmouth Hospitals University NHS Trust /ID# 207932
      • Torquay, United Kingdom, TQ2 7AA
        • Torbay and South Devon Nhs Foundation Trust /Id# 207931
      • Wirral, United Kingdom, CH49 5PE
        • Duplicate_Wirral University Teaching Hospital NHS Foundation Trust /ID# 210535
    • London, City Of
      • London, London, City Of, United Kingdom, E11 1NR
        • Duplicate_Barts Health NHS Trust /ID# 210534
    • Scotland
      • Glasgow, Scotland, United Kingdom, G12 0XH
        • NHS Greater Glasgow and Clyde /ID# 214942
    • Staffordshire
      • Stafford, Staffordshire, United Kingdom, ST16 3SR
        • Midlands Partnership NHS Foundation Trust /ID# 214941
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group /ID# 167955
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Sun Valley Arthritis Center Ltd. /ID# 200270
      • Phoenix, Arizona, United States, 85032-9306
        • AZ Arthritis and Rheumotology Research, PLLC /ID# 209873
      • Tucson, Arizona, United States, 85704
        • Arizona Arthritis & Rheumatology Research, PLLC /ID# 209875
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA Health Care System /ID# 209247
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401-6251
        • Arthritis and Rheumatism Associates /ID# 209882
    • California
      • Los Alamitos, California, United States, 90720-5402
        • Valerius Medical Group & Research Center /ID# 207428
      • San Diego, California, United States, 92128-2549
        • Rheumatology Center of San Diego /ID# 201642
      • Upland, California, United States, 91786
        • Inland Rheum Clin Trials Inc. /ID# 201641
      • Whittier, California, United States, 90606
        • Medvin Clinical Research /ID# 211127
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606-1827
        • New England Research Associates, LLC /ID# 207237
      • Danbury, Connecticut, United States, 06810
        • Danbury Clinical Research, LLC /ID# 209517
      • Hamden, Connecticut, United States, 06518
        • Arthritis & Osteoporosis Center /ID# 207236
    • Florida
      • Aventura, Florida, United States, 33180
        • Arthritis & Rheumatic Disease Specialties /ID# 210802
      • Boca Raton, Florida, United States, 33486
        • Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 211099
      • Gainesville, Florida, United States, 32607-2817
        • SIMED Health, LLC /ID# 207461
      • Hialeah, Florida, United States, 33016-1897
        • Sweet Hope Research Specialty Inc /ID# 209393
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Center for Clinical Research /ID# 209876
      • Orlando, Florida, United States, 32806
        • Rheum Assoc of Central FL /ID# 201622
      • Orlando, Florida, United States, 32819
        • HMD Research LLC /ID# 208427
      • Plantation, Florida, United States, 33324
        • IRIS Research and Development, LLC /ID# 208955
      • Tampa, Florida, United States, 33613-1244
        • ForCare Clinical Research /ID# 168034
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Arthritis and Rheumatology /ID# 168046
    • Illinois
      • Oak Brook, Illinois, United States, 60523-1245
        • Affinity Clinical Research /ID# 210816
      • Rockford, Illinois, United States, 61114-4937
        • OrthoIllinois /ID# 205300
      • Springfield, Illinois, United States, 62702-3749
        • Springfield Clinic /ID# 200244
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Klein and Associates MD /ID# 169483
      • Wheaton, Maryland, United States, 20902
        • The Center for Rheumatology and Bone Research /ID# 168017
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Clinical Pharmacology Study Gr /ID# 168019
    • Michigan
      • Lansing, Michigan, United States, 48910
        • Advanced Rheumatology, PC /ID# 168042
      • Lansing, Michigan, United States, 48910
        • June DO, PC /ID# 208915
    • Minnesota
      • Eagan, Minnesota, United States, 55121
        • St. Paul Rheumatology /ID# 208471
    • Montana
      • Kalispell, Montana, United States, 59901
        • Logan Health Research /ID# 213707
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Physician Research Collaboration, LLC /ID# 208670
    • New York
      • Albany, New York, United States, 12203-3710
        • Center for Rheumatology LLP /ID# 207313
      • Brooklyn, New York, United States, 11201
        • NYU Langone Ambulatory Care Brooklyn Heights /ID# 207310
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Joint & Muscle Research Instit /ID# 208620
      • Greensboro, North Carolina, United States, 27408
        • Medication Management, LLC /ID# 211734
      • New Bern, North Carolina, United States, 28562
        • Coastal Carolina Health Care /ID# 208619
    • Ohio
      • Blue Ash, Ohio, United States, 45242-3763
        • Velocity Clinical Research /ID# 200452
      • Marietta, Ohio, United States, 45750-1635
        • Marietta Memorial Hospital /ID# 210179
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research Con /ID# 201583
      • Springboro, Ohio, United States, 45066
        • STAT Research, Inc. /ID# 213805
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103-2400
        • Health Research of Oklahoma /ID# 168027
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Ctr Clinical Res /ID# 168037
      • Pittsburgh, Pennsylvania, United States, 15212-4756
        • Allegheny Health Network Research Institute /ID# 210349
      • Wyomissing, Pennsylvania, United States, 19610
        • Clinical Research Ctr Reading /ID# 168070
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Nashville Arthritis and Rheumatology /ID# 168069
    • Texas
      • Amarillo, Texas, United States, 79124
        • Amarillo Ctr for Clin Research /ID# 208347
      • Colleyville, Texas, United States, 76034
        • Precision Comprehensive Clinical Research Solutions /ID# 208386
      • Dallas, Texas, United States, 75216
        • Dallas VA Medical Center /ID# 208389
      • Fort Worth, Texas, United States, 76107
        • Precision Comprehensive Clinical Research Solutions /ID# 210597
      • The Woodlands, Texas, United States, 77382
        • Advanced Rheumatology of Houston /ID# 208354
      • Tomball, Texas, United States, 77375
        • DM Clinical Research /ID# 208351
    • Washington
      • Kennewick, Washington, United States, 99336
        • Kadlec Clinic Rheumatology /ID# 207969
    • West Virginia
      • Beckley, West Virginia, United States, 25801
        • Rheumatology and Pulmonary Clinic /ID# 200446
    • Wisconsin
      • Franklin, Wisconsin, United States, 53132
        • Aurora Rheumatology and Immunotherapy Center /ID# 168066
      • Manitowoc, Wisconsin, United States, 54220
        • Holy Family Memorial, Inc. /ID# 209387
      • Onalaska, Wisconsin, United States, 54650
        • Gundersen Clinic, Ltd /ID# 209459

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 for risankizumab administered by subcutaneous injection
Risankizumab administered by subcutaneous injection
Other Names:
  • BI 655066
  • ABBV-066
  • SKYRIZI
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.
Placebo for risankizumab administered by subcutaneous injection
Risankizumab administered by subcutaneous injection
Other Names:
  • BI 655066
  • ABBV-066
  • SKYRIZI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
Time Frame: Baseline and 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).
Baseline and Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline In Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24
Time Frame: Baseline and 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.

Baseline and Week 24
Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24
Time Frame: Baseline and 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.

Baseline and Week 24
Percentage of Participants With an ACR20 Response at Week 16
Time Frame: Baseline and 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).
Baseline and Week 16
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
Time Frame: 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)
Week 24
Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 24
Time Frame: Baseline and 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.

Baseline and Week 24
Change From Baseline in Fingernail-Physician Global Assessment (PGA-F)
Time Frame: Baseline and Week 24
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.
Baseline and Week 24
Percentage of Participants With Resolution of Enthesitis at Week 24
Time Frame: 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).

Week 24
Percentage of Participants With Resolution of Dactylitis at Week 24
Time Frame: 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).

Week 24
Change From Baseline in PsA Modified Total Sharp Score (mTSS) at Week 24
Time Frame: Baseline and 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).

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

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

Baseline and Week 24
Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24
Time Frame: Baseline and 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).
Baseline and Week 24
Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24
Time Frame: Baseline and 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).
Baseline and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2019

Primary Completion (Actual)

October 8, 2020

Study Completion (Anticipated)

September 28, 2026

Study Registration Dates

First Submitted

September 12, 2018

First Submitted That Met QC Criteria

September 15, 2018

First Posted (Actual)

September 18, 2018

Study Record Updates

Last Update Posted (Actual)

May 11, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

For details on when studies are available for sharing, please refer to the link below.

IPD Sharing Access Criteria

Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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