Uno studio per valutare l'efficacia e la sicurezza di JNJ-77242113 (ICOTROKINRA) in partecipanti a naïf biologica con artrite psoriasica attiva (ICONIC-PsA 1)
Uno studio di fase 3, multicentrico, randomizzato, in doppio cieco, controllato con placebo che valuta l'efficacia e la sicurezza di JNJ-77242113 per il trattamento dei partecipanti biologici-naïve con artrite psoriatica attiva
The purpose of this study is to evaluate the efficacy of icotrokinra compared to placebo in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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Buenos Aires, Argentina, C1426BOS
- Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
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Buenos Aires, Argentina, 1428
- Cosultorios Reumatologógicos Pampa
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Buenos Aires, Argentina, C1417EYG
- Mindout Research
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Ciudad de Buenos Aires, Argentina, C1431
- Arsema
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Ciudad de San Miguel de Tucuman, Argentina, T4000AXL
- Centro Medico Privado de Reumatologia Tucuman
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Córdoba, Argentina, CP5000
- Consultora Integral de Salud SRL
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San Fernando, Argentina, B1646GHP
- MR Medicina Reumatologica
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San Isidro, Argentina, B1642IPN
- Instituto Medico De Alta Complejidad (IMAC)
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Ipswich, Australia, 4305
- Ipswich Hospital
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Maroochydore, Australia, 4558
- Rheumatology Research Unit
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Parramatta, Australia, 2150
- BJC Health
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South Woodville, Australia, 5011
- Queen Elizabeth Hospital
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Tiwi, Australia, 0810
- Royal Darwin Hospital
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Haskovo, Bulgaria, 6304
- MC Medtech Services Ltd
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Pleven, Bulgaria, 5803
- Exacta Medica
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Plovdiv, Bulgaria, 4002
- Medical Center Artmed
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Rousse, Bulgaria, 7012
- Medical Center Teodora
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Brno, Cechia, 63800
- Revmatologie s r o
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Brno-Židenice, Cechia, 615 00
- Revmacentrum MUDr Mostera s r o
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Břeclav, Cechia, 690 02
- RHEUMA s r o
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Hlučín, Cechia, 748 01
- L K N Arthrocentrum
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Karvina Frystat, Cechia, 73301
- Revimex Pro s r o
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Ostrava, Cechia, 70800
- MUDr Rosypalova s r o
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Ostrava, Cechia, 70200
- CCR Ostrava S R O
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Prague, Cechia, 140 59
- Thomayerova nemocnice
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Prague, Cechia, 140 00
- Revmatologicka Ordinace
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Prague, Cechia, 150 00
- FN Motol
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Prague, Cechia, 128 00
- Revmatologicky ustav
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Uherské Hradiště, Cechia, 68601
- Medical Plus S R O
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Zlín, Cechia, 76001
- PV Medical S R O
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Beijing, Cina, 100191
- Peking University Third Hospital
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Beijing, Cina, 100730
- Beijing Tong Ren Hospital Capital Medical University
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Changchun, Cina, 130021
- The First Bethune Hospital of Jilin University
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Changsha, Cina, 410008
- Xiangya Hospital Central South University
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Chengdu, Cina, 610041
- West China Hospital Sichuan University
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Chengdu, Cina, 610072
- Sichuan Provincial Peoples Hospital
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Chongqing, Cina, 4000016
- The First Affiliated Hospital of Chongqing Medical University
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Guangzhou, Cina, 510515
- Nanfang Hospital of Southern Medical Hospital
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Guiyang, Cina, 561113
- The Affiliated Hospital of Guizhou Medical University
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Linyi, Cina, 276002
- Linyi City People Hospital
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Nanchang, Cina, 330006
- Jiangxi Provincial Peoples Hospital
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Nanchang, Cina, 330008
- The Second Affiliated Hospital of Nanchang University
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Nantong, Cina, 226001
- Affiliated Hospital of Nantong University
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Pingxiang, Cina, 337055
- Pingxiang People's Hospital
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Shanghai, Cina, 200040
- Huashan Hospital Fudan University
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Shanghai, Cina, 200443
- Shanghai skin disease hospital
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Shenzhen, Cina, 518020
- Shenzhen People s Hospital
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Shijiazhuang, Cina, 050051
- The Third Hospital of Hebei Medical University
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Suzhou, Cina, 215000
- Second Affiliated Hospital of Soochow University
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Taiyuan, Cina, 030032
- Shanxi Bethune Hospital
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Wenzhou, Cina, 325000
- The First Affiliated Hospital of Wenzhou Medical University
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Xi'an, Cina, 710006
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Zhenjiang, Cina, 212001
- Affiliated Hospital of Jiangsu University
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Aarhus N, Danimarca, 8200
- Aarhus University Hospital
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Esbjerg, Danimarca, 6700
- Sydvestjysk Sygehus
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Frederiksberg, Danimarca, 2000
- Frederiksberg Hospital
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Herning, Danimarca, 7400
- Regionshospitalet Godstrup
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Svendborg, Danimarca, 5700
- Svendborg Hospital Odense University Hospital
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Vejle, Danimarca, 7100
- Vejle Sygehus
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Bad Bentheim, Germania, 48455
- Fachklinik Bad Bentheim
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Berlin, Germania, 10117
- Charite Universitaetsmedizin Berlin
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Berlin, Germania, 10789
- ISA - Interdisciplinary Study Association GmbH
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Dresden, Germania, 01307
- Universitatsklinikum Carl Gustav Carus Dresden
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Freiburg im Breisgau, Germania, 79104
- Medizinische Fakultat der Albert Ludwigs Universitat Freiburg
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Hamburg, Germania, 20095
- Hamburger Rheuma Forschungszentrum II
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Herne, Germania, 44649
- Rheumazentrum Ruhrgebiet
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Langenau, Germania, 89129
- Studienzentrum Dr Schwarz Germany
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Minden, Germania, 32429
- Johannes Wesling Klinikum Minden
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Tübingen, Germania, 72076
- Universitatsklinikum Tubingen
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Fukuoka, Giappone, 814 0180
- Fukuoka University Hospital
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Kita Gun, Giappone, 761 0793
- Kagawa University Hospital
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Nagoya, Giappone, 467 8602
- Nagoya City University Hospital
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Osaka, Giappone, 550 0006
- Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
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Sasebo, Giappone, 857 1195
- Sasebo Chuo Hospital
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Sendai, Giappone, 980 8574
- Tohoku University Hospital
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Tokyo, Giappone, 181 8611
- Kyorin University Hospital
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Tsu, Giappone, 514 8507
- Mie University Hospital
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tabashi City, Giappone, 173 8606
- Teikyo University Hospital
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Ōita, Giappone, 870 0030
- Maeshima Rheumatology Clinic
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Hong Kong, Hong Kong, 000000
- Prince of Wales Hospital
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Ahmedabad, India, 380060
- Marengo Cims Hospital
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Bhubaneswar, India, 751005
- Apollo Hospitals
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Hyderabad, India, 500082
- Nizams Institute of Medical Sciences
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Kolkata, India, 700054
- Apollo Multispeciality Hospital Ltd
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Mumbai, India, 400053
- Kokilaben Dhirubhai Ambani Hsp And Med Research Inst
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Mysuru, India, 570004
- JSS Hospital
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New Delhi, India, 110029
- All India Institute of Medical Sciences
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New Delhi, India, 1100776
- Indraprastha Apollo Hospital
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Noida, India, 201301
- Fortis Hospital
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Surat, India, 395002
- SIDS Hospital & Research Centre
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Bialystok, Polonia, 15-879
- ClinicMed Daniluk Nowak Spolka Komandytowa
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Bialystok, Polonia, 15-375
- Specderm Poznanska sp j
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Bialystok, Polonia, 15-351
- Osteo Medic S C Artur Racewicz Jerzy Supronik
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Bydgoszcz, Polonia, 85-168
- Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
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Elblag, Polonia, 82-300
- Centrum Kliniczno Badawcze
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Elblag, Polonia, 82-300
- Ambulatorium sp. z o.o.
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Gdynia, Polonia, 81-338
- Centrum Medyczne Pratia Gdynia
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Krakow, Polonia, 30-727
- Pratia MCM Krakow
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Krakow, Polonia, 30-002
- Malopolskie Badania Kliniczne Sp z o o
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Krakow, Polonia, 30-002
- Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
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Krakow, Polonia, 30-033
- Centrum Medyczne All Med
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Lodz, Polonia, 90-265
- Dermed Centrum Medyczne Sp z o o
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Lublin, Polonia, 20-607
- Zespol Poradni Specjalistycznych Reumed Filia nr 1
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Nadarzyn, Polonia, 05-830
- NZOZ Lecznica MAK MED S C
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Olsztyn, Polonia, 10-117
- Etyka Osrodek Badan Klinicznych
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Torun, Polonia, 87-100
- MICS Centrum Medyczne Torun
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Warsaw, Polonia, 00-874
- MICS Centrum Medyczne Warszawa
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Warsaw, Polonia, 02-665
- Centrum Medyczne Reuma Park
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Wroclaw, Polonia, 52-416
- Centrum Medyczne Oporow
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Wroclaw, Polonia, 51-503
- DermMedica Sp z o o
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A Coruña, Spagna, 15006
- Hosp Univ A Coruna
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Barcelona, Spagna, 8036
- Hosp. Clinic de Barcelona
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Barcelona, Spagna, 08035
- Hosp Univ Vall D Hebron
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Córdoba, Spagna, 14004
- Hosp Reina Sofia
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Madrid, Spagna, 28041
- Hosp. Univ. 12 de Octubre
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Málaga, Spagna, 29009
- Hosp Regional Univ de Malaga
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Sabadell, Spagna, 08208
- Corporacio Sanitari Parc Tauli
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Santander, Spagna, 39008
- Hosp. Univ. Marques de Valdecilla
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Seville, Spagna, 41013
- Hosp. Virgen Del Rocio
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Seville, Spagna, 41009
- Hosp. Virgen Macarena
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Seville, Spagna, 41013
- Hosp. Quiron Sagrado Corazon
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Seville, Spagna, 41010
- Hosp. Infanta Luisa
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Arkansas
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Jonesboro, Arkansas, Stati Uniti, 72401
- Arthritis and Rheumatism Associates ARA Jonesboro
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Florida
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DeBary, Florida, Stati Uniti, 32713
- Omega Research Consultants
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Plantation, Florida, Stati Uniti, 33324
- Integral Rheumatology And Immunology Specialists
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Tampa, Florida, Stati Uniti, 33606
- Clinical Research of West Florida
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Illinois
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Willowbrook, Illinois, Stati Uniti, 60527
- Willow Rheumatology and Wellness PLLC
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North Carolina
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Charlotte, North Carolina, Stati Uniti, 28204
- Joint and Muscle Research Institute
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Pennsylvania
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Duncansville, Pennsylvania, Stati Uniti, 16635
- Altoona Center For Clinical Research
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Texas
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Allen, Texas, Stati Uniti, 75013
- Arthritis and Rheumatology Research Institute
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Harlingen, Texas, Stati Uniti, 78550
- Naiara Alvarez MD Integrative Rheumatology of South TX
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Bangkok, Tailandia, 10400
- Phramongkutklao Hospital
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Bangkok, Tailandia, 10700
- Siriraj Hospital
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Bangkok, Tailandia, 10400
- Rajavithi Hospital
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Changwat Sara Buri, Tailandia, 18000
- Saraburi Hospital
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Phra Nakhon Si Ayutthaya, Tailandia, 13000
- Phra Nakhon Si Ayutthaya Hospital
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Songkhla, Tailandia, 90110
- Songklanagarind hospital
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Hsinchu, Taiwan, 300
- National Taiwan University Hospital Hsin Chu Branch
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Kaohsiung City, Taiwan, 833
- Chang Gung Memorial Hospital
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Tainan, Taiwan, 710
- Chi Mei Medical Center Yong Kang
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital
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Taipei, Taiwan, 112
- Taipei Veterans General Hospital
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Taoyuan, Taiwan, 333
- Linkou Chang Gung Memorial Hospital
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Budapest, Ungheria, 1036
- Obudai Egeszsegugyi Centrum Kft
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Budapest, Ungheria, 1036
- Synexus Magyarorszag Kft
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Budapest, Ungheria, 1152
- Uno Medical Trials Ltd.
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Budapest, Ungheria, 1027
- Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
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Budapest, Ungheria, 1027
- Revita Kft
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Budapest, Ungheria, 1134
- Qualiclinic Kft
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Debrecen, Ungheria, 4032
- University of Debrecen
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Gyula, Ungheria, 5700
- Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
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Kaposvár, Ungheria, 7400
- Obudai Egeszsegugyi Centrum Kft 1
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Szeged, Ungheria, 6725
- University of Szeged
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Szolnok, Ungheria, 5000
- MAV Korhaz es Rendelointezet
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Veszprém, Ungheria, 8200
- Vital Medical Center Orvosi es Fogaszati Kozpont
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Have a diagnosis of psoriatic arthritis (PsA) for at least 3 months before the first administration of study intervention and meet classification criteria for psoriatic arthritis (CASPAR) at screening
- Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (b) C-reactive protein (CRP) greater than or equal to (>=) 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory
- Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
- Have active plaque psoriasis with at least one psoriatic plaque of >= 2 cm diameter or nail changes consistent with psoriasis
- A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention
Exclusion Criteria:
- Has previously received any biologic disease-modifying antirheumatic drugs (DMARDs) for PsA or psoriasis
- Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
- Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients
- Has other inflammatory diseases that might confound the evaluations of benefit of icotrokinra therapy, including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus, or lyme disease
- Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator's opinion, would have potential to interfere with efficacy assessments
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Group I: Icotrokinra Dose 1
Participants will receive icotrokinra dose 1. Participants who continue into a long term extension (LTE) will continue to receive icotrokinra dose 1. |
Icotrokinra will be administered.
Altri nomi:
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Sperimentale: Group II: Icotrokinra Dose 2
Participants will receive icotrokinra dose 2. Participants who continue into a LTE will continue to receive icotrokinra dose 2. |
Icotrokinra will be administered.
Altri nomi:
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Comparatore placebo: Group III: Placebo
Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra dose 1 or dose 2. Participants who continue into the LTE will continue to receive icotrokinra dose 1 or dose 2. |
Placebo will be administered. Icotrokinra will be administered.
Altri nomi:
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Comparatore attivo: Group IV: Active Reference Comparator
Participants will receive active reference drug. Participants who continue into a LTE will cross-over to receive icotrokinra dose 1 or dose 2. |
Icotrokinra will be administered.
Altri nomi:
Active reference drug will be administered. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Proportion of Participants who Achieve an American College of Rheumatology (ACR) ACR 20 Response at Week 16
Lasso di tempo: Week 16
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The ACR 20 responders are participants with an improvement of greater than or equal to (>=) 20 percent (%) from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain visual analog scale (VAS), patient's global assessment of disease activity VAS scale, physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein). |
Week 16
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Proportion of Participants Who Achieve Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than Equal to (>=) 3 Percent (%) and an IGA Score of >=2 at Baseline
Lasso di tempo: Week 16
|
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 75 response represents participants who achieved at least a 75 percent improvement from baseline in the PASI score. |
Week 16
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Proportion of Participants Who Achieve PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline
Lasso di tempo: Week 16
|
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 90 response represents participants who achieved at least a 90 percent improvement from baseline in the PASI score. |
Week 16
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Proportion of Participants Who Achieve PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline
Lasso di tempo: Week 16
|
The PASI is a system used for assessing and grading the severity of psoriatic lesions. In the PASI system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas were assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 to 6, and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that can range from 0 to 72. A higher score indicates more severe disease. A PASI 100 response represents participants who achieved at least a 100 percent improvement from baseline in the PASI score. |
Week 16
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Proportion of Participants with an Investigator Global Assessment (IGA) Psoriasis Score of 0 or 1 And >=2 Grade Improvement From Baseline at Week 16 Among Participants with Baseline BSA >=3% and an IGA Score of >=2 at Baseline
Lasso di tempo: Week 16
|
Proportion of participants with an IGA psoriasis score of 0 or 1 and >=2 grade improvement from baseline at week 16 among participants with >=3% BSA and an IGA score of >=2 at baseline will be reported. The IGA documents the investigator's assessment of the participant's psoriasis at a given time point. Overall lesions are graded for induration, erythema, and scaling, each using a 5-point scale: using 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe) scale. The IGA score of psoriasis is based upon the average of induration, erythema, and scaling scores. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). |
Week 16
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Proportion of Participants who Achieve an ACR 50 Response at Week 16
Lasso di tempo: Week 16
|
The ACR 50 responders are participants with an improvement of >= 50 % from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain VAS, patient's global assessment of disease activity VAS scale, physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein). |
Week 16
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Proportion of Participants who Achieve an ACR 70 Response at Week 16
Lasso di tempo: Week 16
|
The ACR 70 responders are participants with an improvement of >= 70 % from baseline in both the tender and swollen joint count and in at least 3 of the 5 assessments (patient's assessment of pain VAS, patient's global assessment of disease activity VAS scale, Physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein). |
Week 16
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16
Lasso di tempo: From Baseline to Week 16
|
The HAQ-DI score consists of questions referring to 8 categories: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities. Responses in each functional area are scored from 0 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range is 0-3 where 0 = least difficulty and 3 = extreme difficulty. |
From Baseline to Week 16
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Changes From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
Lasso di tempo: From Baseline to Week 16
|
SF-36 is a standardized survey evaluating 8 aspects of functional health and wellbeing: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a domain is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains are averaged to calculate PCS. Total score range for PCS is 0-100 (100=highest level of physical functioning). |
From Baseline to Week 16
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Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline
Lasso di tempo: Week 16
|
Enthesitis will be assessed using the Leeds Enthesitis Index (LEI). The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to lateral elbow epicondyle, left and right, medial femoral condyle, left and right, and achilles tendon insertion, left and right. LEI scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Resolution is defined as participants have enteritis (LEI score >0) at baseline and no enthesis (LEO score =0) at the visit (week 16). |
Week 16
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Change From Baseline in Enthesitis Score (LEI) at Week 16 in Participants With Enthesitis at Baseline
Lasso di tempo: From Baseline to Week 16
|
Enthesitis will be assessed using the LEI. The LEI was developed to assess enthesitis in participants with PsA, and evaluates the presence (score of 1) or absence of pain (score of 0) by applying local pressure to Lateral elbow epicondyle, left and right, Medial femoral condyle, left and right, and Achilles tendon insertion, left and right. LEI total scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). |
From Baseline to Week 16
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Proportion of Participants With Resolution of Dactylitis at Week 16 Among Those With Dactylitis at Baseline
Lasso di tempo: Week 16
|
Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness. Resolution is defined as participants have dactylitis (score >0) at baseline and no dactylitis (score =0) at the visit (week 16). |
Week 16
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Change From Baseline in Dactylitis Score at Week 16 in Participants With Dactylitis at Baseline
Lasso di tempo: From Baseline to Week 16
|
Dactylitis is characterized by swelling of the entire finger or toe. The severity of dactylitis is scored on a scale of 0-3, where 0=tenderness and 3=extreme tenderness in each digit of the hands and feet. The range of total dactylitis scores for a participant is 0-60. Higher score indicates greater degree of tenderness. |
From Baseline to Week 16
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Proportion of Participants who Achieve Minimal Disease Activity (MDA) at Week 16
Lasso di tempo: Week 16
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MDA criteria are a composite of 7 outcome measures used in PsA. Participants are classified as achieving MDA if they fulfill 5 of 7 outcome measures: tender joint count less than or equal to (<=) 1; swollen joint count <= 1; psoriasis activity and severity index <= 1 or body surface area <= 3; patient pain VAS score of <= 15; patient global disease activity VAS (arthritis and psoriasis) score of <= 20; health assessment questionnaire (HAQ) score <= 0.5; and tender entheseal points <= 1. |
Week 16
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Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16
Lasso di tempo: From Baseline to Week 16
|
The FACIT-fatigue is a self-administered, 13-item questionnaire measuring items on tiredness, weakness, and difficulty conducting usual activities due to fatigue. Responses to all items are rated on a 5-point likert response scale ranging from 0 "not at all" to 4 "very much." The total score ranges from 0 to 52, with higher values indicating less fatigue. |
From Baseline to Week 16
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 77242113PSA3001
- 77242113PSA3001 (Altro identificatore: Janssen Research & Development, LLC)
- 2023-509239-19-00 (Identificatore di registro: EUCT number)
- 2023 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
The data sharing policy of Johnson & Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .