En undersøgelse til evaluering (ICONIC-PsA 1)
En fase 3, multicenter, randomiseret, dobbeltblind, placebokontrolleret undersøgelse, der evaluerer effektiviteten og sikkerheden af JNJ-77242113 til behandling af biologiske naive deltagere med aktiv psoriasis arthritis
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.
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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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, Australien, 4305
- Ipswich Hospital
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Maroochydore, Australien, 4558
- Rheumatology Research Unit
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Parramatta, Australien, 2150
- BJC Health
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South Woodville, Australien, 5011
- Queen Elizabeth Hospital
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Tiwi, Australien, 0810
- Royal Darwin Hospital
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Haskovo, Bulgarien, 6304
- MC Medtech Services Ltd
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Pleven, Bulgarien, 5803
- Exacta Medica
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Plovdiv, Bulgarien, 4002
- Medical Center Artmed
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Rousse, Bulgarien, 7012
- Medical Center Teodora
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Aarhus N, Danmark, 8200
- Aarhus University Hospital
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Esbjerg, Danmark, 6700
- Sydvestjysk Sygehus
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Frederiksberg, Danmark, 2000
- Frederiksberg Hospital
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Herning, Danmark, 7400
- Regionshospitalet Godstrup
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Svendborg, Danmark, 5700
- Svendborg Hospital Odense University Hospital
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Vejle, Danmark, 7100
- Vejle Sygehus
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Arkansas
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Jonesboro, Arkansas, Forenede Stater, 72401
- Arthritis and Rheumatism Associates ARA Jonesboro
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Florida
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DeBary, Florida, Forenede Stater, 32713
- Omega Research Consultants
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Plantation, Florida, Forenede Stater, 33324
- Integral Rheumatology And Immunology Specialists
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Tampa, Florida, Forenede Stater, 33606
- Clinical Research of West Florida
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Illinois
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Willowbrook, Illinois, Forenede Stater, 60527
- Willow Rheumatology and Wellness PLLC
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28204
- Joint and Muscle Research Institute
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Pennsylvania
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Duncansville, Pennsylvania, Forenede Stater, 16635
- Altoona Center For Clinical Research
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Texas
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Allen, Texas, Forenede Stater, 75013
- Arthritis and Rheumatology Research Institute
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Harlingen, Texas, Forenede Stater, 78550
- Naiara Alvarez MD Integrative Rheumatology of South TX
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Hong Kong, Hong Kong, 000000
- Prince of Wales Hospital
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Ahmedabad, Indien, 380060
- Marengo Cims Hospital
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Bhubaneswar, Indien, 751005
- Apollo Hospitals
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Hyderabad, Indien, 500082
- Nizams Institute of Medical Sciences
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Kolkata, Indien, 700054
- Apollo Multispeciality Hospital Ltd
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Mumbai, Indien, 400053
- Kokilaben Dhirubhai Ambani Hsp And Med Research Inst
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Mysuru, Indien, 570004
- JSS Hospital
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New Delhi, Indien, 110029
- All India Institute of Medical Sciences
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New Delhi, Indien, 1100776
- Indraprastha Apollo Hospital
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Noida, Indien, 201301
- Fortis Hospital
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Surat, Indien, 395002
- SIDS Hospital & Research Centre
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Fukuoka, Japan, 814 0180
- Fukuoka University Hospital
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Kita Gun, Japan, 761 0793
- Kagawa University Hospital
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Nagoya, Japan, 467 8602
- Nagoya City University Hospital
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Osaka, Japan, 550 0006
- Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
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Sasebo, Japan, 857 1195
- Sasebo Chuo Hospital
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Sendai, Japan, 980 8574
- Tohoku University Hospital
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Tokyo, Japan, 181 8611
- Kyorin University Hospital
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Tsu, Japan, 514 8507
- Mie University Hospital
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tabashi City, Japan, 173 8606
- Teikyo University Hospital
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Ōita, Japan, 870 0030
- Maeshima Rheumatology Clinic
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Beijing, Kina, 100191
- Peking University Third Hospital
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Beijing, Kina, 100730
- Beijing Tong Ren Hospital Capital Medical University
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Changchun, Kina, 130021
- The First Bethune Hospital of Jilin University
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Changsha, Kina, 410008
- Xiangya Hospital Central South University
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Chengdu, Kina, 610041
- West China Hospital Sichuan University
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Chengdu, Kina, 610072
- Sichuan Provincial Peoples Hospital
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Chongqing, Kina, 4000016
- The First Affiliated Hospital of Chongqing Medical University
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Guangzhou, Kina, 510515
- Nanfang Hospital of Southern Medical Hospital
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Guiyang, Kina, 561113
- The Affiliated Hospital of Guizhou Medical University
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Linyi, Kina, 276002
- Linyi City People Hospital
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Nanchang, Kina, 330006
- Jiangxi Provincial Peoples Hospital
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Nanchang, Kina, 330008
- The Second Affiliated Hospital of Nanchang University
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Nantong, Kina, 226001
- Affiliated Hospital of Nantong University
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Pingxiang, Kina, 337055
- Pingxiang People's Hospital
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Shanghai, Kina, 200040
- Huashan Hospital Fudan University
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Shanghai, Kina, 200443
- Shanghai skin disease hospital
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Shenzhen, Kina, 518020
- Shenzhen People s Hospital
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Shijiazhuang, Kina, 050051
- The Third Hospital of Hebei Medical University
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Suzhou, Kina, 215000
- Second Affiliated Hospital of Soochow University
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Taiyuan, Kina, 030032
- Shanxi Bethune Hospital
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Wenzhou, Kina, 325000
- The First Affiliated Hospital of Wenzhou Medical University
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Xi'an, Kina, 710006
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Zhenjiang, Kina, 212001
- Affiliated Hospital of Jiangsu University
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Bialystok, Polen, 15-879
- ClinicMed Daniluk Nowak Spolka Komandytowa
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Bialystok, Polen, 15-375
- Specderm Poznanska sp j
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Bialystok, Polen, 15-351
- Osteo Medic S C Artur Racewicz Jerzy Supronik
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Bydgoszcz, Polen, 85-168
- Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
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Elblag, Polen, 82-300
- Centrum Kliniczno Badawcze
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Elblag, Polen, 82-300
- Ambulatorium sp. z o.o.
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Gdynia, Polen, 81-338
- Centrum Medyczne Pratia Gdynia
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Krakow, Polen, 30-727
- Pratia MCM Krakow
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Krakow, Polen, 30-002
- Malopolskie Badania Kliniczne Sp z o o
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Krakow, Polen, 30-002
- Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
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Krakow, Polen, 30-033
- Centrum Medyczne All Med
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Lodz, Polen, 90-265
- Dermed Centrum Medyczne Sp z o o
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Lublin, Polen, 20-607
- Zespol Poradni Specjalistycznych Reumed Filia nr 1
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Nadarzyn, Polen, 05-830
- NZOZ Lecznica MAK MED S C
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Olsztyn, Polen, 10-117
- Etyka Osrodek Badan Klinicznych
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Torun, Polen, 87-100
- MICS Centrum Medyczne Torun
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Warsaw, Polen, 00-874
- MICS Centrum Medyczne Warszawa
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Warsaw, Polen, 02-665
- Centrum Medyczne Reuma Park
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Wroclaw, Polen, 52-416
- Centrum Medyczne Oporow
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Wroclaw, Polen, 51-503
- DermMedica Sp z o o
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A Coruña, Spanien, 15006
- Hosp Univ A Coruna
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Barcelona, Spanien, 8036
- Hosp. Clinic de Barcelona
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Barcelona, Spanien, 08035
- Hosp Univ Vall D Hebron
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Córdoba, Spanien, 14004
- Hosp Reina Sofia
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Madrid, Spanien, 28041
- Hosp. Univ. 12 de Octubre
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Málaga, Spanien, 29009
- Hosp Regional Univ de Malaga
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Sabadell, Spanien, 08208
- Corporacio Sanitari Parc Tauli
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Santander, Spanien, 39008
- Hosp. Univ. Marques de Valdecilla
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Seville, Spanien, 41013
- Hosp. Virgen Del Rocio
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Seville, Spanien, 41009
- Hosp. Virgen Macarena
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Seville, Spanien, 41013
- Hosp. Quiron Sagrado Corazon
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Seville, Spanien, 41010
- Hosp. Infanta Luisa
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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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Bangkok, Thailand, 10400
- Phramongkutklao Hospital
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Bangkok, Thailand, 10700
- Siriraj Hospital
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Bangkok, Thailand, 10400
- Rajavithi Hospital
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Changwat Sara Buri, Thailand, 18000
- Saraburi Hospital
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Phra Nakhon Si Ayutthaya, Thailand, 13000
- Phra Nakhon Si Ayutthaya Hospital
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Songkhla, Thailand, 90110
- Songklanagarind hospital
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Brno, Tjekkiet, 63800
- Revmatologie s r o
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Brno-Židenice, Tjekkiet, 615 00
- Revmacentrum MUDr Mostera s r o
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Břeclav, Tjekkiet, 690 02
- RHEUMA s r o
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Hlučín, Tjekkiet, 748 01
- L K N Arthrocentrum
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Karvina Frystat, Tjekkiet, 73301
- Revimex Pro s r o
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Ostrava, Tjekkiet, 70800
- MUDr Rosypalova s r o
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Ostrava, Tjekkiet, 70200
- CCR Ostrava S R O
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Prague, Tjekkiet, 140 59
- Thomayerova nemocnice
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Prague, Tjekkiet, 140 00
- Revmatologicka Ordinace
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Prague, Tjekkiet, 150 00
- FN Motol
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Prague, Tjekkiet, 128 00
- Revmatologicky ustav
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Uherské Hradiště, Tjekkiet, 68601
- Medical Plus S R O
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Zlín, Tjekkiet, 76001
- PV Medical S R O
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Bad Bentheim, Tyskland, 48455
- Fachklinik Bad Bentheim
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Berlin, Tyskland, 10117
- Charite Universitaetsmedizin Berlin
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Berlin, Tyskland, 10789
- ISA - Interdisciplinary Study Association GmbH
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Dresden, Tyskland, 01307
- Universitatsklinikum Carl Gustav Carus Dresden
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Freiburg im Breisgau, Tyskland, 79104
- Medizinische Fakultat der Albert Ludwigs Universitat Freiburg
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Hamburg, Tyskland, 20095
- Hamburger Rheuma Forschungszentrum II
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Herne, Tyskland, 44649
- Rheumazentrum Ruhrgebiet
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Langenau, Tyskland, 89129
- Studienzentrum Dr Schwarz Germany
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Minden, Tyskland, 32429
- Johannes Wesling Klinikum Minden
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Tübingen, Tyskland, 72076
- Universitatsklinikum Tubingen
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Budapest, Ungarn, 1036
- Obudai Egeszsegugyi Centrum Kft
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Budapest, Ungarn, 1036
- Synexus Magyarorszag Kft
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Budapest, Ungarn, 1152
- Uno Medical Trials Ltd.
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Budapest, Ungarn, 1027
- Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
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Budapest, Ungarn, 1027
- Revita Kft
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Budapest, Ungarn, 1134
- Qualiclinic Kft
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Debrecen, Ungarn, 4032
- University of Debrecen
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Gyula, Ungarn, 5700
- Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
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Kaposvár, Ungarn, 7400
- Obudai Egeszsegugyi Centrum Kft 1
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Szeged, Ungarn, 6725
- University of Szeged
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Szolnok, Ungarn, 5000
- MAV Korhaz es Rendelointezet
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Veszprém, Ungarn, 8200
- Vital Medical Center Orvosi es Fogaszati Kozpont
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
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Eksperimentel: 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.
Andre navne:
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Eksperimentel: 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.
Andre navne:
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Placebo komparator: 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.
Andre navne:
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Aktiv komparator: 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.
Andre navne:
Active reference drug will be administered. |
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of Participants who Achieve an American College of Rheumatology (ACR) ACR 20 Response at Week 16
Tidsramme: 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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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 16
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Week 16
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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
Tidsramme: 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
Tidsramme: Week 16
|
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
Tidsramme: From Baseline to Week 16
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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
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 77242113PSA3001
- 77242113PSA3001 (Anden identifikator: Janssen Research & Development, LLC)
- 2023-509239-19-00 (Registry Identifier: EUCT number)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .