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

Psoriatic Arthritis Clinical Trial

— KEEPsAKE 1  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03675308
• Other study ID #: M16-011
• Secondary ID: 2017-002465-22
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 25, 2019
• Est. completion date: September 28, 2026

Study information

• Verified date: April 2023
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 964
• Est. completion date: September 28, 2026
• Est. primary completion date: October 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Biological:
• Placebo
Placebo for risankizumab administered by subcutaneous injection
• Risankizumab
Risankizumab administered by subcutaneous injection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Bosnia and Herzegovina,  Brazil,  Bulgaria,  Canada,  Chile,  Croatia,  Czechia,  Denmark,  Estonia,  Finland,  Germany,  Greece,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Ukraine,  United Kingdom, 

References & Publications (1)

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 t — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: = 20% improvement in 68-tender joint count; = 20% improvement in 66-swollen joint count; and; = 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	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.	Baseline and Week 24
Secondary	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.	Baseline and Week 24
Secondary	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: = 20% improvement in 68-tender joint count; = 20% improvement in 66-swollen joint count; and; = 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
Secondary	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)	Week 24
Secondary	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.	Baseline and Week 24
Secondary	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.	Baseline and Week 24
Secondary	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).	Week 24
Secondary	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).	Week 24
Secondary	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).	Baseline and Week 24
Secondary	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.	Baseline and Week 24
Secondary	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.	Baseline and Week 24
Secondary	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: = 50% improvement in 68-tender joint count; = 50% improvement in 66-swollen joint count; and; = 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
Secondary	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: = 70% improvement in 68-tender joint count; = 70% improvement in 66-swollen joint count; and; = 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

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