Исследование для оценки эффективности и безопасности JNJ-77242113 (iCotrokinra) у биологических участников с активным псориатическим артритом (ICONIC-PsA 1)
Фаза 3, многоцентровое рандомизированное, двойное слепое, плацебо-контролируемое исследование, оценивающее эффективность и безопасность JNJ-77242113 для лечения биологических участников с активным псориатическим артритом
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Действительный)
Фаза
- Фаза 3
Контакты и местонахождение
Места учебы
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Ipswich, Австралия, 4305
- Ipswich Hospital
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Maroochydore, Австралия, 4558
- Rheumatology Research Unit
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Parramatta, Австралия, 2150
- BJC Health
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South Woodville, Австралия, 5011
- Queen Elizabeth Hospital
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Tiwi, Австралия, 0810
- Royal Darwin Hospital
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Buenos Aires, Аргентина, C1426BOS
- Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
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Buenos Aires, Аргентина, 1428
- Cosultorios Reumatologógicos Pampa
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Buenos Aires, Аргентина, C1417EYG
- Mindout Research
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Ciudad de Buenos Aires, Аргентина, C1431
- Arsema
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Ciudad de San Miguel de Tucuman, Аргентина, T4000AXL
- Centro Medico Privado de Reumatologia Tucuman
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Córdoba, Аргентина, CP5000
- Consultora Integral de Salud SRL
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San Fernando, Аргентина, B1646GHP
- MR Medicina Reumatologica
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San Isidro, Аргентина, B1642IPN
- Instituto Medico De Alta Complejidad (IMAC)
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Haskovo, Болгария, 6304
- MC Medtech Services Ltd
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Pleven, Болгария, 5803
- Exacta Medica
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Plovdiv, Болгария, 4002
- Medical Center Artmed
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Rousse, Болгария, 7012
- Medical Center Teodora
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Budapest, Венгрия, 1036
- Obudai Egeszsegugyi Centrum Kft
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Budapest, Венгрия, 1036
- Synexus Magyarorszag Kft
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Budapest, Венгрия, 1152
- Uno Medical Trials Ltd.
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Budapest, Венгрия, 1027
- Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
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Budapest, Венгрия, 1027
- Revita Kft
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Budapest, Венгрия, 1134
- Qualiclinic Kft
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Debrecen, Венгрия, 4032
- University of Debrecen
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Gyula, Венгрия, 5700
- Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
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Kaposvár, Венгрия, 7400
- Obudai Egeszsegugyi Centrum Kft 1
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Szeged, Венгрия, 6725
- University of Szeged
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Szolnok, Венгрия, 5000
- MAV Korhaz es Rendelointezet
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Veszprém, Венгрия, 8200
- Vital Medical Center Orvosi es Fogaszati Kozpont
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Bad Bentheim, Германия, 48455
- Fachklinik Bad Bentheim
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Berlin, Германия, 10117
- Charite Universitaetsmedizin Berlin
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Berlin, Германия, 10789
- ISA - Interdisciplinary Study Association GmbH
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Dresden, Германия, 01307
- Universitatsklinikum Carl Gustav Carus Dresden
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Freiburg im Breisgau, Германия, 79104
- Medizinische Fakultat der Albert Ludwigs Universitat Freiburg
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Hamburg, Германия, 20095
- Hamburger Rheuma Forschungszentrum II
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Herne, Германия, 44649
- Rheumazentrum Ruhrgebiet
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Langenau, Германия, 89129
- Studienzentrum Dr Schwarz Germany
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Minden, Германия, 32429
- Johannes Wesling Klinikum Minden
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Tübingen, Германия, 72076
- Universitatsklinikum Tubingen
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Hong Kong, Гонконг, 000000
- Prince of Wales Hospital
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Aarhus N, Дания, 8200
- Aarhus University Hospital
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Esbjerg, Дания, 6700
- Sydvestjysk Sygehus
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Frederiksberg, Дания, 2000
- Frederiksberg Hospital
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Herning, Дания, 7400
- Regionshospitalet Godstrup
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Svendborg, Дания, 5700
- Svendborg Hospital Odense University Hospital
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Vejle, Дания, 7100
- Vejle Sygehus
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Ahmedabad, Индия, 380060
- Marengo Cims Hospital
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Bhubaneswar, Индия, 751005
- Apollo Hospitals
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Hyderabad, Индия, 500082
- Nizams Institute of Medical Sciences
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Kolkata, Индия, 700054
- Apollo Multispeciality Hospital Ltd
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Mumbai, Индия, 400053
- Kokilaben Dhirubhai Ambani Hsp And Med Research Inst
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Mysuru, Индия, 570004
- JSS Hospital
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New Delhi, Индия, 110029
- All India Institute of Medical Sciences
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New Delhi, Индия, 1100776
- Indraprastha Apollo Hospital
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Noida, Индия, 201301
- Fortis Hospital
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Surat, Индия, 395002
- SIDS Hospital & Research Centre
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A Coruña, Испания, 15006
- Hosp Univ A Coruna
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Barcelona, Испания, 8036
- Hosp. Clinic de Barcelona
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Barcelona, Испания, 08035
- Hosp Univ Vall D Hebron
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Córdoba, Испания, 14004
- Hosp Reina Sofia
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Madrid, Испания, 28041
- Hosp. Univ. 12 de Octubre
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Málaga, Испания, 29009
- Hosp Regional Univ de Malaga
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Sabadell, Испания, 08208
- Corporacio Sanitari Parc Tauli
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Santander, Испания, 39008
- Hosp. Univ. Marques de Valdecilla
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Seville, Испания, 41013
- Hosp. Virgen Del Rocio
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Seville, Испания, 41009
- Hosp. Virgen Macarena
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Seville, Испания, 41013
- Hosp. Quiron Sagrado Corazon
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Seville, Испания, 41010
- Hosp. Infanta Luisa
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Beijing, Китай, 100191
- Peking University Third Hospital
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Beijing, Китай, 100730
- Beijing Tong Ren Hospital Capital Medical University
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Changchun, Китай, 130021
- The First Bethune Hospital of Jilin University
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Changsha, Китай, 410008
- Xiangya Hospital Central South University
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Chengdu, Китай, 610041
- West China Hospital Sichuan University
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Chengdu, Китай, 610072
- Sichuan Provincial Peoples Hospital
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Chongqing, Китай, 4000016
- The First Affiliated Hospital of Chongqing Medical University
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Guangzhou, Китай, 510515
- Nanfang Hospital of Southern Medical Hospital
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Guiyang, Китай, 561113
- The Affiliated Hospital of Guizhou Medical University
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Linyi, Китай, 276002
- Linyi City People Hospital
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Nanchang, Китай, 330006
- Jiangxi Provincial Peoples Hospital
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Nanchang, Китай, 330008
- The Second Affiliated Hospital of Nanchang University
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Nantong, Китай, 226001
- Affiliated Hospital of Nantong University
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Pingxiang, Китай, 337055
- Pingxiang People's Hospital
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Shanghai, Китай, 200040
- Huashan Hospital Fudan University
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Shanghai, Китай, 200443
- Shanghai skin disease hospital
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Shenzhen, Китай, 518020
- Shenzhen People s Hospital
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Shijiazhuang, Китай, 050051
- The Third Hospital of Hebei Medical University
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Suzhou, Китай, 215000
- Second Affiliated Hospital of Soochow University
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Taiyuan, Китай, 030032
- Shanxi Bethune Hospital
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Wenzhou, Китай, 325000
- The First Affiliated Hospital of Wenzhou Medical University
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Xi'an, Китай, 710006
- The Second Affiliated Hospital of Xi'an Jiaotong University
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Zhenjiang, Китай, 212001
- Affiliated Hospital of Jiangsu University
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Bialystok, Польша, 15-879
- ClinicMed Daniluk Nowak Spolka Komandytowa
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Bialystok, Польша, 15-375
- Specderm Poznanska sp j
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Bialystok, Польша, 15-351
- Osteo Medic S C Artur Racewicz Jerzy Supronik
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Bydgoszcz, Польша, 85-168
- Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
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Elblag, Польша, 82-300
- Centrum Kliniczno Badawcze
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Elblag, Польша, 82-300
- Ambulatorium sp. z o.o.
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Gdynia, Польша, 81-338
- Centrum Medyczne Pratia Gdynia
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Krakow, Польша, 30-727
- Pratia MCM Krakow
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Krakow, Польша, 30-002
- Malopolskie Badania Kliniczne Sp z o o
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Krakow, Польша, 30-002
- Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
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Krakow, Польша, 30-033
- Centrum Medyczne All Med
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Lodz, Польша, 90-265
- Dermed Centrum Medyczne Sp z o o
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Lublin, Польша, 20-607
- Zespol Poradni Specjalistycznych Reumed Filia nr 1
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Nadarzyn, Польша, 05-830
- NZOZ Lecznica MAK MED S C
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Olsztyn, Польша, 10-117
- Etyka Osrodek Badan Klinicznych
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Torun, Польша, 87-100
- MICS Centrum Medyczne Torun
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Warsaw, Польша, 00-874
- MICS Centrum Medyczne Warszawa
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Warsaw, Польша, 02-665
- Centrum Medyczne Reuma Park
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Wroclaw, Польша, 52-416
- Centrum Medyczne Oporow
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Wroclaw, Польша, 51-503
- DermMedica Sp z o o
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Arkansas
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Jonesboro, Arkansas, Соединенные Штаты, 72401
- Arthritis and Rheumatism Associates ARA Jonesboro
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Florida
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DeBary, Florida, Соединенные Штаты, 32713
- Omega Research Consultants
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Plantation, Florida, Соединенные Штаты, 33324
- Integral Rheumatology And Immunology Specialists
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Tampa, Florida, Соединенные Штаты, 33606
- Clinical Research of West Florida
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Illinois
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Willowbrook, Illinois, Соединенные Штаты, 60527
- Willow Rheumatology and Wellness PLLC
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North Carolina
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Charlotte, North Carolina, Соединенные Штаты, 28204
- Joint and Muscle Research Institute
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Pennsylvania
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Duncansville, Pennsylvania, Соединенные Штаты, 16635
- Altoona Center For Clinical Research
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Texas
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Allen, Texas, Соединенные Штаты, 75013
- Arthritis and Rheumatology Research Institute
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Harlingen, Texas, Соединенные Штаты, 78550
- Naiara Alvarez MD Integrative Rheumatology of South TX
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Bangkok, Таиланд, 10400
- Phramongkutklao Hospital
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Bangkok, Таиланд, 10700
- Siriraj Hospital
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Bangkok, Таиланд, 10400
- Rajavithi Hospital
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Changwat Sara Buri, Таиланд, 18000
- Saraburi Hospital
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Phra Nakhon Si Ayutthaya, Таиланд, 13000
- Phra Nakhon Si Ayutthaya Hospital
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Songkhla, Таиланд, 90110
- Songklanagarind hospital
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Hsinchu, Тайвань, 300
- National Taiwan University Hospital Hsin Chu Branch
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Kaohsiung City, Тайвань, 833
- Chang Gung Memorial Hospital
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Tainan, Тайвань, 710
- Chi Mei Medical Center Yong Kang
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Tainan, Тайвань, 704
- National Cheng Kung University Hospital
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Taipei, Тайвань, 112
- Taipei Veterans General Hospital
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Taoyuan, Тайвань, 333
- Linkou Chang Gung Memorial Hospital
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Brno, Чехия, 63800
- Revmatologie s r o
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Brno-Židenice, Чехия, 615 00
- Revmacentrum MUDr Mostera s r o
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Břeclav, Чехия, 690 02
- RHEUMA s r o
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Hlučín, Чехия, 748 01
- L K N Arthrocentrum
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Karvina Frystat, Чехия, 73301
- Revimex Pro s r o
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Ostrava, Чехия, 70800
- MUDr Rosypalova s r o
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Ostrava, Чехия, 70200
- CCR Ostrava S R O
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Prague, Чехия, 140 59
- Thomayerova nemocnice
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Prague, Чехия, 140 00
- Revmatologicka Ordinace
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Prague, Чехия, 150 00
- FN Motol
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Prague, Чехия, 128 00
- Revmatologicky ustav
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Uherské Hradiště, Чехия, 68601
- Medical Plus S R O
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Zlín, Чехия, 76001
- PV Medical S R O
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Fukuoka, Япония, 814 0180
- Fukuoka University Hospital
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Kita Gun, Япония, 761 0793
- Kagawa University Hospital
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Nagoya, Япония, 467 8602
- Nagoya City University Hospital
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Osaka, Япония, 550 0006
- Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
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Sasebo, Япония, 857 1195
- Sasebo Chuo Hospital
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Sendai, Япония, 980 8574
- Tohoku University Hospital
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Tokyo, Япония, 181 8611
- Kyorin University Hospital
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Tsu, Япония, 514 8507
- Mie University Hospital
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tabashi City, Япония, 173 8606
- Teikyo University Hospital
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Ōita, Япония, 870 0030
- Maeshima Rheumatology Clinic
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Двойной
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
Другие имена:
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Экспериментальный: 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.
Другие имена:
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Плацебо Компаратор: 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.
Другие имена:
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Активный компаратор: 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.
Другие имена:
Active reference drug will be administered. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportion of Participants who Achieve an American College of Rheumatology (ACR) ACR 20 Response at Week 16
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: From Baseline to 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. |
From Baseline to Week 16
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Proportion of Participants who Achieve Minimal Disease Activity (MDA) at Week 16
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Следователи
- Директор по исследованиям: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 77242113PSA3001
- 77242113PSA3001 (Другой идентификатор: Janssen Research & Development, LLC)
- 2023-509239-19-00 (Идентификатор реестра: EUCT number)
- 2023 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
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Описание плана 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
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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