Clinical trial NCT03675308: 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
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Psoriatic Arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-09-18
Enrollment: 964
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Change From Baseline In Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Achieving Psoriasis Area Severity Index (PASI) 90 Response at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With an ACR20 Response at Week 16
timeFrame: Baseline and Week 16
measure: Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
timeFrame: Week 24
measure: Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) Score at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Fingernail-Physician Global Assessment (PGA-F)
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Resolution of Enthesitis at Week 24
timeFrame: Week 24
measure: Percentage of Participants With Resolution of Dactylitis at Week 24
timeFrame: Week 24
measure: Change From Baseline in PsA Modified Total Sharp Score (mTSS) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline In 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline In Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 24
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group /ID# 167955
state: Alabama
city: Peoria
country: United States
facility: Sun Valley Arthritis Center Ltd. /ID# 200270
state: Arizona
city: Phoenix
country: United States
facility: AZ Arthritis and Rheumotology Research, PLLC /ID# 209873
state: Arizona
city: Tucson
country: United States
facility: Arizona Arthritis & Rheumatology Research, PLLC /ID# 209875
state: Arizona
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System /ID# 209247
state: Arizona
city: Jonesboro
country: United States
facility: Arthritis and Rheumatism Associates /ID# 209882
state: Arkansas
city: Los Alamitos
country: United States
facility: Valerius Medical Group & Research Center /ID# 207428
state: California
city: San Diego
country: United States
facility: Rheumatology Center of San Diego /ID# 201642
state: California
city: Upland
country: United States
facility: Inland Rheum Clin Trials Inc. /ID# 201641
state: California
city: Whittier
country: United States
facility: Medvin Clinical Research /ID# 211127
state: California
city: Bridgeport
country: United States
facility: New England Research Associates, LLC /ID# 207237
state: Connecticut
city: Danbury
country: United States
facility: Danbury Clinical Research, LLC /ID# 209517
state: Connecticut
city: Hamden
country: United States
facility: Arthritis & Osteoporosis Center /ID# 207236
state: Connecticut
city: Aventura
country: United States
facility: Arthritis & Rheumatic Disease Specialties /ID# 210802
state: Florida
city: Boca Raton
country: United States
facility: Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 211099
state: Florida
city: Gainesville
country: United States
facility: SIMED Health, LLC /ID# 207461
state: Florida
city: Hialeah
country: United States
facility: Sweet Hope Research Specialty Inc /ID# 209393
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research /ID# 209876
state: Florida
city: Orlando
country: United States
facility: Rheum Assoc of Central FL /ID# 201622
state: Florida
city: Orlando
country: United States
facility: HMD Research LLC /ID# 208427
state: Florida
city: Plantation
country: United States
facility: IRIS Research and Development, LLC /ID# 208955
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research /ID# 168034
state: Florida
city: Atlanta
country: United States
facility: Arthritis and Rheumatology /ID# 168046
state: Georgia
city: Oak Brook
country: United States
facility: Affinity Clinical Research /ID# 210816
state: Illinois
city: Rockford
country: United States
facility: OrthoIllinois /ID# 205300
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic /ID# 200244
state: Illinois
city: Hagerstown
country: United States
facility: Klein and Associates MD /ID# 169483
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research /ID# 168017
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Gr /ID# 168019
state: Massachusetts
city: Lansing
country: United States
facility: Advanced Rheumatology, PC /ID# 168042
state: Michigan
city: Lansing
country: United States
facility: June DO, PC /ID# 208915
state: Michigan
city: Eagan
country: United States
facility: St. Paul Rheumatology /ID# 208471
state: Minnesota
city: Kalispell
country: United States
facility: Logan Health Research /ID# 213707
state: Montana
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC /ID# 208670
state: Nebraska
city: Albany
country: United States
facility: Center for Rheumatology LLP /ID# 207313
state: New York
city: Brooklyn
country: United States
facility: NYU Langone Ambulatory Care Brooklyn Heights /ID# 207310
state: New York
city: Charlotte
country: United States
facility: Joint & Muscle Research Instit /ID# 208620
state: North Carolina
city: Greensboro
country: United States
facility: Medication Management, LLC /ID# 211734
state: North Carolina
city: New Bern
country: United States
facility: Coastal Carolina Health Care /ID# 208619
state: North Carolina
city: Blue Ash
country: United States
facility: Velocity Clinical Research /ID# 200452
state: Ohio
city: Marietta
country: United States
facility: Marietta Memorial Hospital /ID# 210179
state: Ohio
city: Middleburg Heights
country: United States
facility: Paramount Medical Research Con /ID# 201583
state: Ohio
city: Springboro
country: United States
facility: STAT Research, Inc. /ID# 213805
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma /ID# 168027
state: Oklahoma
city: Duncansville
country: United States
facility: Altoona Ctr Clinical Res /ID# 168037
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Health Network Research Institute /ID# 210349
state: Pennsylvania
city: Wyomissing
country: United States
facility: Clinical Research Ctr Reading /ID# 168070
state: Pennsylvania
city: Nashville
country: United States
facility: Nashville Arthritis and Rheumatology /ID# 168069
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Ctr for Clin Research /ID# 208347
state: Texas
city: Colleyville
country: United States
facility: Precision Comprehensive Clinical Research Solutions /ID# 208386
state: Texas
city: Dallas
country: United States
facility: Dallas VA Medical Center /ID# 208389
state: Texas
city: Fort Worth
country: United States
facility: Precision Comprehensive Clinical Research Solutions /ID# 210597
state: Texas
city: The Woodlands
country: United States
facility: Advanced Rheumatology of Houston /ID# 208354
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research /ID# 208351
state: Texas
city: Kennewick
country: United States
facility: Kadlec Clinic Rheumatology /ID# 207969
state: Washington
city: Beckley
country: United States
facility: Rheumatology and Pulmonary Clinic /ID# 200446
state: West Virginia
city: Franklin
country: United States
facility: Aurora Rheumatology and Immunotherapy Center /ID# 168066
state: Wisconsin
city: Manitowoc
country: United States
facility: Holy Family Memorial, Inc. /ID# 209387
state: Wisconsin
city: Onalaska
country: United States
facility: Gundersen Clinic, Ltd /ID# 209459
state: Wisconsin
city: La Plata
country: Argentina
facility: Framingham Centro Medico /ID# 210409
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos J. M. Ramos Mejia /ID# 169164
state: Ciuadad Autonoma De Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires /ID# 208474
state: Ciuadad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: DOM Centro de Reumatologia /ID# 208479
state: Ciuadad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Fundacion CIDEA /ID# 210494
state: Ciuadad Autonoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich /ID# 211622
state: Ciuadad Autonoma De Buenos Aires
city: Rosario
country: Argentina
facility: Centro de Enfermedades del Hígado y Aparato Digestivo /ID# 169163
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto CAICI /ID# 169168
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico Privado de Reumatologia /ID# 208343
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Duplicate_Inst de Rehab Psicofisica /ID# 214681
city: Cordoba
country: Argentina
facility: Duplicate_Hospital Privado Univesitario /ID# 211623
city: San Miguel de Tucuman
country: Argentina
facility: Cimer /Id# 169167
city: Garran
country: Australia
facility: The Canberra Hospital /ID# 207592
state: Australian Capital Territory
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital /ID# 212785
state: Queensland
city: Maroochydore
country: Australia
facility: Rheumatology Research Unit Sunshine Coast /ID# 207200
state: Queensland
city: Southport
country: Australia
facility: Griffith University /ID# 207505
state: Queensland
city: Bedford, Park
country: Australia
facility: Flinders Medical Centre /ID# 210562
state: South Australia
city: Camberwell
country: Australia
facility: Emeritus Research /ID# 207202
state: Victoria
city: Clayton
country: Australia
facility: Monash Medical Centre /ID# 208034
state: Victoria
city: Ghent
country: Belgium
facility: Duplicate_UZ Ghent /ID# 210036
state: Oost-Vlaanderen
city: Genk
country: Belgium
facility: ReumaClinic /ID# 208213
city: Merksem
country: Belgium
facility: ZNA - Jan Palfijn /ID# 208212
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska /ID# 208268
state: Republika Srpska
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska /ID# 208269
state: Republika Srpska
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Centre of the Republic of Srpska /ID# 210047
state: Republika Srpska
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinical Center University of Sarajevo /ID# 208272
city: Salvador
country: Brazil
facility: SER - Serviços Especializados em Reumatologia /ID# 207489
state: Bahia
city: Juiz de Fora
country: Brazil
facility: CMiP - Centro Mineiro de Pesquisa Ltda - ME /ID# 207496
state: Minas Gerais
city: Curitiba
country: Brazil
facility: EDUMED Educacao em Saude S/S L /ID# 207488
state: Parana
city: Porto Alegre
country: Brazil
facility: LMK Sevicos Medicos S/S /ID# 207491
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: CPCLIN - Centro de Pesquisas Clínicas /ID# 207493
city: Pleven
country: Bulgaria
facility: Medical center Medconsult /ID# 211399
city: Sofia
country: Bulgaria
facility: Medical center Excelsior /ID# 167741
city: Sofia
country: Bulgaria
facility: Diagnostic consultative center 17 Sofia /ID# 210506
city: Sofia
country: Bulgaria
facility: Military Medical Academy Multiprofile Hospital /ID# 210829
city: Victoria
country: Canada
facility: Percuro Clinical Research, Ltd /ID# 169601
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Clinic /ID# 206819
state: Manitoba
city: Winnipeg
country: Canada
facility: CIADS Research Co Ltd /ID# 169600
state: Manitoba
city: Peterborough
country: Canada
facility: SKIN Centre for Dermatology /ID# 169604
state: Ontario
city: Waterloo
country: Canada
facility: K. Papp Clinical Research /ID# 169603
state: Ontario
city: Sainte-foy
country: Canada
facility: Groupe de Recherche en Maladies Osseuses Inc /ID# 169598
state: Quebec
city: Saskatoon
country: Canada
facility: Dr. Latha Naik /ID# 212188
state: Saskatchewan
city: Providencia
country: Chile
facility: CTR Estudios Clinicos /ID# 208166
city: Santiago
country: Chile
facility: Centro Internacional de Estudios Clinicos /ID# 209908
city: Vitacura Santiago
country: Chile
facility: Clinica Dermacross S.A /ID# 208163
city: Zagreb
country: Croatia
facility: Poliklinika Repromed /ID# 208628
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Poliklinika Solmed /ID# 210965
state: Grad Zagreb
city: Osijek
country: Croatia
facility: UHC Osijek /ID# 208623
state: Osjecko-baranjska Zupanija
city: Rijeka
country: Croatia
facility: Klinicki bolnicki centar Rijeka /ID# 208621
state: Primorsko-goranska Zupanija
city: Split
country: Croatia
facility: Klinicki bolnicki centar Split /ID# 208626
state: Splitsko-dalmatinska Zupanija
city: Zagreb
country: Croatia
facility: Medical Center Kuna-Peric /ID# 208047
city: Zagreb
country: Croatia
facility: Poliklinika Bonifarm /ID# 208750
city: Brno
country: Czechia
facility: Revmacentrum MUDr. Mostera, s.r.o. /ID# 209025
city: Praha
country: Czechia
facility: PV MEDICAL Services s.r.o. /ID# 210222
city: Praha
country: Czechia
facility: MUDr. Zuzana Stejfova - revmatologicka ambulance /ID# 209027
city: Praha
country: Czechia
facility: Affidea Praha s.r.o. /ID# 210223
city: Uherske Hradiste
country: Czechia
facility: MEDICAL PLUS, s.r.o. /ID# 210439
city: Frederiksberg
country: Denmark
facility: Bispebjerg and Frederiksberg Hospital /ID# 207576
state: Hovedstaden
city: Aarhus C
country: Denmark
facility: Aarhus University Hospital /ID# 168761
state: Midtjylland
city: Mustamäe Linnaosa
country: Estonia
facility: North Estonia Medical Centre /ID# 208325
state: Harjumaa
city: Tallinn
country: Estonia
facility: Innomedica /ID# 211416
state: Harjumaa
city: Tartu
country: Estonia
facility: MediTrials /ID# 207816
state: Tartumaa
city: Helsinki
country: Finland
facility: Helsinki University Hospital /ID# 207724
state: Uusimaa
city: Kuopio
country: Finland
facility: Ite Pihlajanlinna Kuopio /ID# 208322
city: Turku
country: Finland
facility: Turku University Hospital /ID# 207726
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet /ID# 207216
state: Nordrhein-Westfalen
city: Berlin-buch
country: Germany
facility: Immanuel Krankenhaus Berlin /ID# 207218
city: Frankfurt
country: Germany
facility: Center of Innovative Diagnostics and Therapeutics (CIRI GmbH) /ID# 209483
city: Hamburg
country: Germany
facility: MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 209484
city: Athens
country: Greece
facility: General Hospital Asklepieio Voulas /ID# 212956
state: Attiki
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion PA.G.N.I /ID# 206839
state: Kriti
city: Efkarpia (Thessalonikis)
country: Greece
facility: 424 General MILITARY Hospital /ID# 210974
state: Thessaloniki
city: Athens
country: Greece
facility: Naval Hospital of Athens /ID# 206838
city: Patras
country: Greece
facility: Olympion General Clinic SA /ID# 207048
city: Ramat Gan
country: Israel
facility: Sheba Medical Center /ID# 207474
state: Tel-Aviv
city: Ashkelon
country: Israel
facility: Barzilai Medical Center /ID# 207476
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 208170
city: Kfar Saba
country: Israel
facility: Meir Medical Center /ID# 207473
city: Petakh Tikva
country: Israel
facility: Rabin Medical Center /ID# 207475
city: Modena
country: Italy
facility: Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207799
state: Emilia-Romagna
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 207269
city: Catania
country: Italy
facility: A.O.U. Policlinico G. Rodolico S.Marco - Presidio San Marco /ID# 207795
city: Rome
country: Italy
facility: Duplicate_Policlinico Univ Tor Vergata /ID# 207271
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Roma /ID# 207265
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital /ID# 209263
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Duplicate_Konkuk University Medical Ctr /ID# 207509
state: Seoul Teugbyeolsi
city: Daegu
country: Korea, Republic of
facility: Kyungpook National Univ Hosp /ID# 207408
city: Adazi
country: Latvia
facility: M & M Centrs LTD /ID# 208733
city: Liepaja
country: Latvia
facility: D.Saulites-Kandevicas PP in Cardiology and Rheumatology /ID# 207224
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital /ID# 207220
city: Riga
country: Latvia
facility: Clinic ORTO /ID# 216218
city: Riga
country: Latvia
facility: Riga East Clinical University Hospital /ID# 207223
city: Kaunas
country: Lithuania
facility: VAKK Dr. Kilda's Clinic /ID# 207330
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207331
city: Klaipeda
country: Lithuania
facility: Klaipeda University Hospital /ID# 207329
city: Siauliai
country: Lithuania
facility: Republican Siauliai hospital /ID# 207328
city: Seremban
country: Malaysia
facility: Hospital Tuanku Jaafar /ID# 207919
state: Negeri Sembilan
city: Ipoh
country: Malaysia
facility: Hospital Raja Permaisuri Bainun /ID# 207920
state: Perak
city: Batu Caves
country: Malaysia
facility: Hospital Selayang /ID# 208938
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Med Ctr /ID# 208937
city: Mexico City
country: Mexico
facility: CINTRE, Centro de Investigación y Tratamiento Reumatológico SC /ID# 208331
state: Ciudad De Mexico
city: Guadalajara
country: Mexico
facility: Centro Integral en Reumatologia S.A de C.V /ID# 208346
state: Jalisco
city: Monterrey
country: Mexico
facility: Eukarya PharmaSite, SC /ID# 208431
state: Nuevo Leon
city: Colonia Centro
country: Mexico
facility: Centro Peninsular de Investigación Clínica SCP /ID# 208345
state: Yucatan
city: Ciudad de Mexico
country: Mexico
facility: Hospital General Regional No. 1 Dr. Carlos Mac Gregor Sánchez Navarro /ID# 210835
city: Mexico City
country: Mexico
facility: RM Pharma Specialists S.A de C.V /ID# 208330
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis /ID# 208587
state: Fryslan
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen /ID# 208580
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden /ID# 168453
city: Papatoetoe
country: New Zealand
facility: Middlemore Clinical Trials /ID# 213256
state: Auckland
city: Hamilton
country: New Zealand
facility: Waikato Hospital /ID# 213257
state: Waikato
city: Burwood
country: New Zealand
facility: CGM Research Trust /ID# 210498
city: Bydgoszcz
country: Poland
facility: Spolka Lekarzy INTERCOR /ID# 210191
state: Kujawsko-pomorskie
city: Torun
country: Poland
facility: Nasz Lekarz Przychodnie Medyczne /ID# 216176
state: Kujawsko-pomorskie
city: Krakow
country: Poland
facility: Malopolskie Centrum Kliniczne /ID# 208007
state: Malopolskie
city: Grodzisk Mazowiecki
country: Poland
facility: McBk Sc /Id# 209132
state: Mazowieckie
city: Warsaw
country: Poland
facility: Centrum Medyczne Reuma Park w Warszawie /ID# 210352
state: Mazowieckie
city: Bialystok
country: Poland
facility: Osteo-Medic S.C. /ID# 208008
state: Podlaskie
city: Bialystok
country: Poland
facility: ClinicMed Daniluk, Nowak Sp.j. /ID# 210824
state: Podlaskie
city: Elblag
country: Poland
facility: Centrum Kliniczno-Badawcze /ID# 208010
state: Warminsko-mazurskie
city: Olsztyn
country: Poland
facility: ETYKA-Osrodek Badan Klinicznych /ID# 216241
state: Warminsko-mazurskie
city: Vila Nova De Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE /ID# 208145
state: Porto
city: Ponte de Lima
country: Portugal
facility: Unidade Local de Saúde do Alto Minho, EPE - Hospital Conde de Bertiandos /ID# 208147
state: Viana Do Castelo
city: Aveiro
country: Portugal
facility: Centro Hospitalar do Baixo Vouga /ID# 215979
city: Braga
country: Portugal
facility: CCA Braga - Hospital de Braga /ID# 208146
city: Lisboa
country: Portugal
facility: Instituto Português De Reumatologia /ID# 208149
city: Lisboa
country: Portugal
facility: Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 208148
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research /ID# 211129
city: Timisoara
country: Romania
facility: Cabinet Medical Dr Triff Carina /Id# 207528
state: Timis
city: Bucuresti
country: Romania
facility: Spitalul Clinic Sf. Maria /ID# 210054
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj -Napoca /ID# 207340
city: Iasi
country: Romania
facility: Spitalul Clinic de Recuperare Iasi /ID# 207371
city: Korolev
country: Russian Federation
facility: LLC Family Outpatient Clinic № /ID# 169510
state: Moskva
city: Moscow
country: Russian Federation
facility: Research Institute of Rheumatology named after V.A. Nasonova /ID# 207643
state: Moskva
city: Novosibirsk
country: Russian Federation
facility: LLC Medical Center /ID# 169516
state: Novosibirskaya Oblast
city: St. Petersburg
country: Russian Federation
facility: Nort-Western State Medical University n.a. Mechnikov /ID# 207641
state: Sankt-Peterburg
city: Kazan
country: Russian Federation
facility: Kazan State Medical University /ID# 169511
state: Tatarstan, Respublika
city: Moscow
country: Russian Federation
facility: Federal Center for Brain and Neurotechnology /ID# 207646
city: Perm
country: Russian Federation
facility: Perm Regional Clinical Hospital /ID# 207642
city: Ulyanovsk
country: Russian Federation
facility: Ulyanovsk Regional Clinical Hospital /ID# 169515
city: Belgrade
country: Serbia
facility: Institute for Rheumatology /ID# 168194
state: Beograd
city: Belgrade
country: Serbia
facility: Institute for Rheumatology /ID# 168197
state: Beograd
city: Belgrade
country: Serbia
facility: Institute for Rheumatology /ID# 168198
state: Beograd
city: Belgrade
country: Serbia
facility: Institute for Rheumatology /ID# 168199
state: Beograd
city: Belgrade
country: Serbia
facility: Military Medical Academy /ID# 168218
state: Beograd
city: Novi Sad
country: Serbia
facility: Special Hospital for Rheuma /ID# 168255
state: Vojvodina
city: Novi Sad
country: Serbia
facility: Special Hospital for Rheuma /ID# 210284
state: Vojvodina
city: Singapore
country: Singapore
facility: National University Hospital /ID# 208599
city: Singapore
country: Singapore
facility: Singapore General Hospital /ID# 207917
city: Singapore
country: Singapore
facility: Changi General Hospital /ID# 208965
city: Biely Kostol
country: Slovakia
facility: REUMA-GLOBAL, s.r.o. /ID# 208017
city: Martin
country: Slovakia
facility: MEDMAN s.r.o. /ID# 208018
city: Nove Mesto nad Vahom
country: Slovakia
facility: Reum.hapi s.r.o. /ID# 208016
city: Piestany
country: Slovakia
facility: Thermium s.r.o. /ID# 208015
city: Poprad
country: Slovakia
facility: REUMAMED POPRAD s.r.o. /ID# 208407
city: Port Elizabeth
country: South Africa
facility: Dr Jenny Potts /ID# 168691
state: Eastern Cape
city: Pretoria
country: South Africa
facility: University of Pretoria /ID# 167621
state: Gauteng
city: Pretoria
country: South Africa
facility: Dr Elsa van Duuren /ID# 207577
state: Gauteng
city: Cape Town
country: South Africa
facility: Arthritis Clinical Research Trials /ID# 167625
state: Western Cape
city: Somerset West
country: South Africa
facility: Synexus Helderberg Clinical Research Centre /ID# 210891
state: Western Cape
city: Stellenbosch
country: South Africa
facility: Winelands Medical Research Centre /ID# 167629
state: Western Cape
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol /ID# 208543
state: Barcelona
city: Sabadell
country: Spain
facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207830
state: Barcelona
city: A Coruna
country: Spain
facility: Hospital Universitario A Coruna - CHUAC /ID# 207826
city: Almeria
country: Spain
facility: Hospital Universitario Torrecardenas /ID# 212716
city: Barcelona
country: Spain
facility: Hospital Parc de Salut del Mar /ID# 209698
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos /ID# 207832
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre /ID# 207827
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 207831
city: Orebro
country: Sweden
facility: Orebro Universitetssjukhuset /ID# 207948
state: Orebro Lan
city: Malmo
country: Sweden
facility: Skane University hospital /ID# 210070
state: Skane Lan
city: Falun
country: Sweden
facility: Falu Lasarett /ID# 210322
city: Solna
country: Sweden
facility: Duplicate_Karolinska Univ Sjukhuset /ID# 208175
city: Uppsala
country: Sweden
facility: Uppsala University Hospital /ID# 207944
city: Vasteras
country: Sweden
facility: Duplicate_Vastmanlands Sjukhus /ID# 207943
city: Chia-Yi
country: Taiwan
facility: Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 207567
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital /ID# 207257
city: Taoyuan City
country: Taiwan
facility: Linkou Chang Gung Memorial Ho /ID# 207255
city: Kharkiv
country: Ukraine
facility: State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 209556
state: Kharkivska Oblast
city: Vinnytsia
country: Ukraine
facility: Scientific Research Institute of Invalid Rehabilitation /ID# 207873
state: Vinnytska Oblast
city: Cherkasy
country: Ukraine
facility: CNE Cherkasy Regional Hospital of Cherkasy Regional Council /ID# 207912
city: Chernihiv
country: Ukraine
facility: MNPE Chernihiv Regional Hospital of the Chernihiv Region Council /ID# 207730
city: Kharkiv
country: Ukraine
facility: PNE City Multifunctional Hospital No.18 /ID# 207911
city: Khmelnytskyi
country: Ukraine
facility: Khmelnytskyi Regional Hospital /ID# 207753
city: Kryvyi Rih
country: Ukraine
facility: MI Kryvyi Rih City Clinical Hospital No.2 /ID# 207748
city: Kyiv
country: Ukraine
facility: Medical Center OK Clinic /ID# 207749
city: Lutsk
country: Ukraine
facility: Communal Enterprise Volyn Regional Clinical hospital of the Volyn Regional Coun /ID# 208276
city: Lviv
country: Ukraine
facility: Lviv Municipal City Clinical Hospital #4 /ID# 207715
city: Poltava
country: Ukraine
facility: PI "Poltava Regional Clinical Hospital n.a. M.V.Sklifosovsky" /ID# 207872
city: Zaporizhzhia
country: Ukraine
facility: Public Institution 6th City Clinical Hospital /ID# 207754
city: London
country: United Kingdom
facility: Duplicate_Barts Health NHS Trust /ID# 210534
state: London, City Of
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde /ID# 214942
state: Scotland
city: Stafford
country: United Kingdom
facility: Midlands Partnership NHS Foundation Trust /ID# 214941
state: Staffordshire
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust /ID# 207928
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals University NHS Trust /ID# 207932
city: Torquay
country: United Kingdom
facility: Torbay and South Devon Nhs Foundation Trust /Id# 207931
city: Wirral
country: United Kingdom
facility: Duplicate_Wirral University Teaching Hospital NHS Foundation Trust /ID# 210535
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.