Studie na vyhodnocení účinnosti a bezpečnosti icotrokinra (JNJ-77242113) u biologicky zkušených účastníků s aktivní psoriatickou artritidou (ICONIC-PsA 2)
Fáze 3, multicentrická, randomizovaná, dvojitě slepá, placebem kontrolovaná studie hodnotící účinnost a bezpečnost JNJ-77242113 pro léčbu biologicky zkušených účastníků s aktivní psoriatickou artritidou
The purpose of this study is to evaluate the efficacy of icotrokinra (JNJ-77242113) compared to placebo in biologic-experienced and biologic-naive participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Buenos Aires, Argentina, B1643CRO
- Instituto Medico De Alta Complejidad (IMAC)
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Buenos Aires, Argentina, C1406AGA
- ARCIS Salud SRL Aprillus asistencia e investigacion
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Buenos Aires, Argentina, C1426
- Hospital Militar Central Cir. My. Dr. Cosme Argerich
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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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San Fernando, Argentina, B1646GHP
- MR Medicina Reumatologica
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Ipswich, Austrálie, 4305
- Ipswich Hospital
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Maroochydore, Austrálie, 4558
- Rheumatology Research Unit
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South Woodville, Austrálie, 5011
- Queen Elizabeth Hospital
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St Leonards, Austrálie, 2065
- Royal North Shore Hospital
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Tiwi, Austrálie, 0810
- Royal Darwin Hospital
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Belo Horizonte, Brazílie, 30130 100
- Faculdade de Medicina Universidade Federal de Minas Gerais
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Porto Alegre, Brazílie, 90480 000
- LMK Servicos Medicos S S
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São José do Rio Preto, Brazílie, 15090-000
- Funfarme Sjrp
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São Paulo, Brazílie, 05403 900
- Hospital Das Clinicas Da Faculdade De Medicina Da USP
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São Paulo, Brazílie, 01236030
- BR Trials
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São Paulo, Brazílie, 04266 010
- CEPIC Centro Paulista de Investigacao Clinica e Servicos Medicos
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Plovdiv, Bulharsko, 4003
- Multiprofile Hospital for Active Treatment Plovdiv
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Plovdiv, Bulharsko, 4001
- UMHAT Kaspela
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Sliven, Bulharsko, 8801
- Diagnostic Consulting Center I Sliven
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Sofia, Bulharsko, 1431
- Diagnostic-Consultative Center (DCC) Aleksandrovska
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Sofia, Bulharsko, 1336
- Multiprofile Hospital for Active Treatment - MHAT Lyulin EAD
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Sofia, Bulharsko, 1612
- UMHAT St. Ivan Rilski
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Sofia, Bulharsko, 1750
- ASIMP Rheumatology Centre St Irina EOOD
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Sofia, Bulharsko, 1407
- MC Ekselsior
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Aarhus N, Dánsko, 8200
- Aarhus University Hospital
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Esbjerg, Dánsko, 6700
- Sydvestjysk Sygehus
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Frederiksberg, Dánsko, 2000
- Frederiksberg Hospital
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Herning, Dánsko, 7400
- Regionshospitalet Godstrup
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Svendborg, Dánsko, 5700
- Svendborg Hospital Odense University Hospital
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Vejle, Dánsko, 7100
- Vejle Sygehus
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Hong Kong, Hongkong
- Queen Mary Hospital
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Hong Kong, Hongkong, 000000
- Prince of Wales Hospital
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Ahmedabad, Indie, 380060
- Marengo Cims Hospital
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Bhubaneswar, Indie, 751005
- Apollo Hospitals
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Hubballi, Indie, 580021
- Sushruta Multispeciality Hospital
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Kolkata, Indie, 700054
- Apollo Multispeciality Hospital Ltd
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Mysuru, Indie, 570004
- JSS Hospital
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New Delhi, Indie, 110029
- All India Institute of Medical Sciences
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New Delhi, Indie, 1100776
- Indraprastha Apollo Hospital
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Noida, Indie, 201301
- Fortis Hospital
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Surat, Indie, 395002
- SIDS (Surat Institute of Digestive Sciences) Hospital and Research Centre
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Ancona, Itálie, 60126
- A.O. Universitaria Ospedali Riuniti di Ancona
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Brescia, Itálie, 25123
- ASST Spedali Civili Brescia
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Catania, Itálie, 95124
- Policlinico San Marco
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Milan, Itálie, 20132
- Ospedale San Raffaele
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Naples, Itálie, 80138
- Azienda Ospedaliero Universitaria Luigi Vanvitelli
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Pavia, Itálie, 27100
- IRCCS Policlinico San Matteo
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Roma, Itálie, 00133
- Universita Degli Studi di Roma Tor Vergata
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Roma, Itálie, 00168
- Fondazione Policlinico Universitario A Gemelli IRCCS
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Rozzano, Itálie, 20089
- Istituto Clinico Humanitas
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Siena, Itálie, 53100
- A O Universitaria Senese Ospedale Santa Maria alle Scotte
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Udine, Itálie, 33100
- Ospedale S. Maria Della Misericordia
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Chiba, Japonsko, 260-8712
- NHO Chiba Medical Center Chibahigashi National Hospital
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Chūōku, Japonsko, 104 8560
- St. Luke's International Hospital
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Hirakata, Japonsko, 573 1191
- Kansai Medical University Hospital
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Hyōgo, Japonsko, 6751392
- Kita-harima Medical Center
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Kitakyushu-shi, Japonsko, 807-8556
- Hospital of the University of Occupational and Environmental Health
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Nagoya, Japonsko, 467 8602
- Nagoya City University Hospital
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Osaka, Japonsko, 550 0006
- Public Interest Incorporated Foundation Nipoon Life Saiseikai Nippon Life Hospital
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Osaka, Japonsko, 545 8586
- Osaka Metropolitan University Hospital
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Sanuki, Japonsko, 7692393
- Sanuki Municipal Hospital
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Sasebo, Japonsko, 857 1195
- Sasebo Chuo Hospital
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Sendai, Japonsko, 980 8574
- Tohoku University Hospital
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Shimotsuga Gun, Japonsko, 321 0293
- Dokkyo Medical University Hospital
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Tokyo, Japonsko, 181 8611
- Kyorin University Hospital
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Tsu, Japonsko, 514 8507
- Mie University Hospital
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Yokohama, Japonsko, 245-8575
- National Hospital Organization Yokohama Medical Center
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Ōita, Japonsko, 870 0030
- Maeshima Rheumatology Clinic
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Kanada, A1C 5B8
- Eastern Regional Health Authority St Clares Mercy Hospital
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Ontario
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Orillia, Ontario, Kanada, L3V 1T5
- The Waterside Clinic
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Toronto, Ontario, Kanada, M5S 1B1
- Womens College Hospital
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Waterloo, Ontario, Kanada, N2J 1C4
- Alliance Clinical Trials
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Windsor, Ontario, Kanada, N8X 1T3
- Dr Sabeen Anwar Medicine Professional Corporation
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Quebec
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Montreal, Quebec, Kanada, H1T 2M4
- Hospital Maisonneuve-Rosemont
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Trois-Rivières, Quebec, Kanada, G9A 3X2
- Centre de Recherche Musculo Squelettique
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Alor Star, Malajsie, 05460
- Hospital Sultanah Bahiyah
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Batu Caves, Malajsie, 68100
- Hospital Selayang
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Ipoh, Malajsie, 30450
- Hospital Raja Permaisuri Bainun
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Johor Bahru, Malajsie, 81100
- Hospital Sultan Ismail
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Kuala Lumpur, Malajsie, 50586
- Hospital Kuala Lumpur
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Seremban, Malajsie, 70300
- Hospital Tuanku Jaafar
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Budapest, Maďarsko, 1152
- Uno Medical Trials Ltd.
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Budapest, Maďarsko, 1023
- Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz
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Budapest, Maďarsko, 1027
- Revita Kft
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Budapest, Maďarsko, 1134
- Qualiclinic Kft
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Békéscsaba, Maďarsko, 5600
- Trial Pharma Kft
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Debrecen, Maďarsko, 4032
- Debreceni Egyetem Reumatologiai Klinika
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Gyula, Maďarsko, 5700
- Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaz
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Hódmezővásárhely, Maďarsko, 6800
- Porcika Klinika - Vasarhelyi Sarkanyfu Kft.
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Kaposvár, Maďarsko, 7400
- Obudai Egeszsegugyi Centrum Kft
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Kecskemét, Maďarsko, 6000
- Bacs Kiskun Varmegyei Oktatokorhaz
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Szeged, Maďarsko, 6725
- University of Szeged
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Szolnok, Maďarsko, 5000
- MAV Korhaz es Rendelointezet
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Székesfehérvár, Maďarsko, 8000
- Complex Rendelo Med Zrt
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Székesfehérvár, Maďarsko, 8000
- Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
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Veszprém, Maďarsko, 8200
- Vital Medical Center Orvosi es Fogaszati Kozpont
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Culiacán, Mexiko, 80000
- Centro de Investigacion de Tratamientos Innovadores de Sinaloa
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Guadalajara, Mexiko, 44630
- Grupo Clinico CATEI
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Mexicali, Mexiko, 45116
- Centro Medico del Angel
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Mexico City, Mexiko, 03100
- RM Pharma Specialists
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Monterrey, Mexiko, 64460
- Hospital Universitario Dr Jose Eleuterio Gonzalez
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San Luis Potosí City, Mexiko, 78213
- Centro de Alta Especialidad en Reumatologia e Investigacion
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Berlin, Německo, 10789
- ISA - Interdisciplinary Study Association GmbH
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Berlin, Německo, 10117
- Charite - Campus Mitte
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Cologne, Německo, 51149
- Krankenhaus Porz am Rhein
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Dresden, Německo, 01307
- Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden
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Freiburg im Breisgau, Německo, 79106
- Medizinische Fakultaet Der Albert Ludwigs Universitaet Freiburg
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Hamburg, Německo, 20095
- Hamburger Rheuma Forschungszentrum II
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Herne, Německo, 44649
- Rheumazentrum Ruhrgebiet
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Langenau, Německo, 89129
- Praxis Dr. med. Beate Schwarz - Germany
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Ratingen, Německo, 40878
- Rheumaforschung - Studienambulanz Dr. Wassenberg
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Tübingen, Německo, 72076
- Universitatsklinikum Tubingen
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Bialystok, Polsko, 15-879
- ClinicMed Daniluk Nowak Spolka Komandytowa
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Bialystok, Polsko, 15-351
- Osteo-Medic s.c A. Racewicz, J Supronik
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Bialystok, Polsko, 15-375
- Specderm Poznanska sp j
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Bydgoszcz, Polsko, 85-168
- Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
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Elblag, Polsko, 82-300
- Centrum Kliniczno Badawcze
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Elblag, Polsko, 82-300
- Ambulatorium sp. z o.o.
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Gdynia, Polsko, 81-338
- Centrum Medyczne Pratia Gdynia
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Krakow, Polsko, 30-727
- Pratia MCM Krakow
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Krakow, Polsko, 30-002
- Malopolskie Badania Kliniczne Sp z o o
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Krakow, Polsko, 30-002
- Specjalistyczny gabinet dermatologiczny Aplikacyjno Badawczy Marek Brzewski Pawel Brzewski Spolka Cywilna
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Krakow, Polsko, 30-033
- Centrum Medyczne All Med
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Lodz, Polsko, 90-265
- Dermed Centrum Medyczne Sp z o o
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Lublin, Polsko, 20-607
- Zespol Poradni Specjalistycznych Reumed Filia nr 1
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Nadarzyn, Polsko, 05-830
- NZOZ Lecznica MAK MED S C
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Torun, Polsko, 87-100
- MICS Centrum Medyczne Torun
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Warsaw, Polsko, 00-874
- MICS Centrum Medyczne Warszawa
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Warsaw, Polsko, 02-665
- Centrum Medyczne Reuma Park
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Wroclaw, Polsko, 52-416
- Centrum Medyczne Oporow
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Wroclaw, Polsko, 51-503
- DermMedica Sp z o o
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Bucharest, Rumunsko, 014142
- S C Delta Health Care S R L
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Bucharest, Rumunsko, 012071
- Quantum Medical Center Srl
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Bucharest, Rumunsko, 030463
- CCBR Clinical Research
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Bucharest, Rumunsko, 041312
- Hiperdia Piata Sudului
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Craiova, Rumunsko, 200400
- Ecomed Research SRL
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Iași, Rumunsko, 700259
- Centrul Medical Unirea
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Râmnicu Vâlcea, Rumunsko, 247065
- Medaudio Optica S R L
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Barnet, Spojené království, EN5 3DJ
- Royal Free London NHS Foundation Trust
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Basingstoke, Spojené království, RG24 9NA
- Basingstoke And North Hampshire Hospital
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Christchurch, Spojené království, BH23 2JX
- University Hospitals Dorset NHS Foundation Trust
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Edinburgh, Spojené království, EH4 2XU
- Western General Hospital
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Glasgow, Spojené království, G31 2ER
- Glasgow Royal Infirmary
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Hereford, Spojené království, HR1 2ER
- Hereford County Hospital
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Larbert, Spojené království, FK5 4WR
- Forth Valley Royal Hospital
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Staffordshire, Spojené království, ST6 7AG
- Haywood Hospital
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Torquay, Spojené království, TQ2 7AA
- Torbay Hospital-Devon
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Wolverhampton, Spojené království, WV10 0QP
- New Cross Hospital
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Wrexham, Spojené království, LL13 7TD
- Betsi Cadwaladr University Health Board BCUHB
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Arizona
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Glendale, Arizona, Spojené státy, 85306
- AARA Clinical Research
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Mesa, Arizona, Spojené státy, 85210
- AARA Clinical Research 1
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Arkansas
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Jonesboro, Arkansas, Spojené státy, 72401
- Arthritis and Rheumatism Associates ARA Jonesboro
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Florida
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Clearwater, Florida, Spojené státy, 33765
- Clinical Research of West Florida
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DeBary, Florida, Spojené státy, 32713
- Omega Research Consultants
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New Port Richey, Florida, Spojené státy, 34652
- Suncoast Clinical Research
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Plantation, Florida, Spojené státy, 33324
- Integral Rheumatology And Immunology Specialists
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Tampa, Florida, Spojené státy, 33606
- Clinical Research of West Florida 1
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Illinois
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Skokie, Illinois, Spojené státy, 60076
- Clinic of Robert Hozman
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Maryland
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Hagerstown, Maryland, Spojené státy, 21740
- Klein And Associates M D P A
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Massachusetts
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Brookline, Massachusetts, Spojené státy, 02446
- DM Clinical Research 1
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Minnesota
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Eagan, Minnesota, Spojené státy, 55123
- St Paul Rheumatology PA
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87102
- Albuquerque Rehabilitation and Rheumatology
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North Carolina
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Charlotte, North Carolina, Spojené státy, 28204
- Joint and Muscle Research Institute
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73116
- Rheumatology Associates of Oklahoma
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Pennsylvania
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Duncansville, Pennsylvania, Spojené státy, 16635
- Altoona Center For Clinical Research
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Philadelphia, Pennsylvania, Spojené státy, 19114
- Clinical Research Philadelphia
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Texas
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Dallas, Texas, Spojené státy, 75390
- UT Southwestern
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Frisco, Texas, Spojené státy, 75035
- Arthritis and Rheumatology Research Institute
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Harlingen, Texas, Spojené státy, 78550
- Naiara Alvarez MD Integrative Rheumatology of South TX
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Irving, Texas, Spojené státy, 75039
- AARA Clinical Research Lone Star Arthritis and Rheumatology
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Tomball, Texas, Spojené státy, 77375
- DM Clinical Research
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Waco, Texas, Spojené státy, 76710
- Velocity Clinical Research
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Washington
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Seattle, Washington, Spojené státy, 98104
- Seattle Rheumatology
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Wisconsin
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Glendale, Wisconsin, Spojené státy, 53217
- Center of Rheumatic Diseases
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Hsinchu, Tchaj-wan, 300
- National Taiwan University Hospital Hsin Chu Branch
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Kaohsiung City, Tchaj-wan, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Tainan, Tchaj-wan, 710
- Chi Mei Medical Center
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Taipei, Tchaj-wan, 112
- Taipei Veterans General Hospital
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Bangkok, Thajsko, 10400
- Phramongkutklao Hospital
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Bangkok, Thajsko, 10700
- Siriraj Hospital
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Bangkok, Thajsko, 10400
- Rajavithi Hospital
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Changwat Sara Buri, Thajsko, 18000
- Saraburi Hospital
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Songkhla, Thajsko, 90110
- Songklanagarind hospital
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Ankara, Turecko (Türkiye), 06010
- Gulhane Egitim ve Arastirma Hastanesi
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Ankara, Turecko (Türkiye), 06570
- Gazi Universitesi Tip Fakultesi
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Gaziantep, Turecko (Türkiye), 27090
- Sanko Universitesi Hastanesi
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Istanbul, Turecko (Türkiye), 34899
- Marmara University Medical Faculty
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Kocaeli, Turecko (Türkiye), 41001
- Kocaeli University Medical Faculty
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Konya, Turecko (Türkiye), 42080
- Necmettin Erbakan Universitesi Tip Fakultesi
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Brno, Česko, 63800
- Revmatologie s r o
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Brno, Česko, 615 00
- Revmacentrum MUDr Mostera s r o
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Břeclav, Česko, 690 02
- RHEUMA s r o
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Hlučín, Česko, 748 01
- L K N Arthrocentrum
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Ostrava, Česko, 70200
- CCR Ostrava S R O
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Ostrava, Česko, 708 00
- MUDr Rosypalova s r o
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Prague, Česko, 13000
- Pratia Czech s r o
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Prague, Česko, 15000
- FN Motol
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Uherské Hradiště, Česko, 68601
- Medical Plus S R O
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Zlín, Česko, 76001
- PV Medical S R O
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Beijing, Čína, 100083
- Peking University Third Hospital
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Beijing, Čína, 100730
- Beijing Tong Ren Hospital Capital Medical University
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Changchun, Čína, 130021
- The First Bethune Hospital of Jilin University
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Changsha, Čína, 410008
- Xiangya Hospital Central South University
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Chengdu, Čína, 610041
- West China Hospital Sichuan University
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Chengdu, Čína, 610072
- Sichuan Provincial Peoples Hospital
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Chongqing, Čína, 400016
- The First Affiliated Hospital of Chongqing Medical University
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Dongguan, Čína, 523109
- Dongguan People s Hospital
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Guangzhou, Čína, 510515
- Nanfang Hospital of Southern Medical Hospital
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Guiyang, Čína, 550004
- The Affiliated Hospital of Guizhou Medical University
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Hangzhou, Čína, 310018
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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Jiaxing, Čína, 314001
- The First Hospital of Jiaxing
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Jinhua, Čína, 321000
- Jinhua municipal central hospital
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Linfen, Čína, 041000
- Linfen Central Hospital
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Linyi, Čína, 276002
- Linyi City People Hospital
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Nanchang, Čína, 330008
- The Second Affiliated Hospital of Nanchang University
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Nantong, Čína, 226001
- Affiliated Hospital of Nantong University
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Pingxiang, Čína, 337055
- Pingxiang People's Hospital
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Shanghai, Čína, 200040
- Huashan Hospital Fudan University
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Shanghai, Čína, 200443
- Shanghai skin disease hospital
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Shenzhen, Čína, 518020
- Shenzhen People s Hospital
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Suzhou, Čína, 215004
- Second Affiliated Hospital of Soochow University
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Taiyuan, Čína, 030032
- Shanxi Bethune Hospital
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Wenzhou, Čína, 325000
- The First Affiliated Hospital of Wenzhou Medical University
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Xi'an, Čína, 710006
- The Second Affiliated Hospital of Xi'an Jiaotong University
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A Coruña, Španělsko, 15006
- Hosp Univ A Coruna
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Córdoba, Španělsko, 14004
- Hosp Reina Sofia
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L'Hospitalet de Llobregat, Španělsko, 08907
- Hosp. Univ. de Bellvitge
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Madrid, Španělsko, 28031
- Hosp. Univ. Infanta Leonor
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Málaga, Španělsko, 29009
- Hosp Regional Univ de Malaga
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Santander, Španělsko, 39008
- Hosp. Univ. Marques de Valdecilla
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Santiago de Compostela, Španělsko, 15706
- Hosp. Clinico Univ. de Santiago
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Seville, Španělsko, 41013
- Hosp. Virgen Del Rocio
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Seville, Španělsko, 41009
- Hosp. Virgen Macarena
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Seville, Španělsko, 41014
- Hosp. Ntra. Sra. de Valme
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Seville, Španělsko, 41010
- Hosp. Infanta Luisa
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Have active psoriatic arthritis (PsA) despite current or previous use of greater than or equal to (>=) 1 of the following: a. Non-biologic disease-modifying antirheumatic drug (DMARD) therapy; b. Apremilast therapy; c. Biologic-agent (limited to only 1)
- Have a diagnosis of 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) >= 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 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
- Currently has a malignancy or has a history of malignancy within 5 years prior to screening
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Group I: Icotrokinra Dose 1
Participants will receive icotrokinra Dose 1. Participants who have not discontinued will be eligible to enter a long term extension (LTE) and will continue to receive icotrokinra Dose 1. |
Icotrokinra will be administered.
Ostatní jména:
|
|
Experimentální: Group II: Icotrokinra Dose 2
Participants will receive icotrokinra Dose 2. Participants who have not discontinued will be eligible to enter a LTE and will continue to receive icotrokinra Dose 2. |
Icotrokinra will be administered.
Ostatní jména:
|
|
Komparátor placeba: Group III: Placebo
Participants will receive placebo matched to icotrokinra and will cross over to receive icotrokinra Dose 1 or Dose 2 at Week 16. Participants who have not discontinued will be eligible to enter a LTE and will continue to receive icotrokinra Dose 1 or Dose 2. |
Placebo will be administered. Icotrokinra will be administered.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of Participants who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16
Časové okno: Week 16
|
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 [arthritis, VAS] scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein). |
Week 16
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of Participants Who Achieved 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 With Baseline IGA Score of >=2
Časové okno: 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
|
|
Proportion of Participants Who Achieved PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2
Časové okno: 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
|
|
Proportion of Participants Who Achieved PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2
Časové okno: 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
|
|
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 With Baseline IGA Score of >=2
Časové okno: 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
|
|
Proportion of Participants who Achieved an ACR 50 Response at Week 16
Časové okno: 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 (arthritis, VAS) scale, Physician's global assessment of disease activity VAS scale, Health Assessment Questionnaire and C-reactive protein). |
Week 16
|
|
Proportion of Participants who Achieved an ACR 70 Response at Week 16
Časové okno: 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 (arthritis, VAS) scale, Physician's global assessment of disease activity VAS scale, health assessment questionnaire and C-reactive protein). |
Week 16
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16
Časové okno: From baseline up 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 was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. |
From baseline up to Week 16
|
|
Changes From Baseline in 36 Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16
Časové okno: From baseline up 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 was an average of the individual question scores, which were scaled 0 to 100 (100=highest level of functioning). Score from physical function, role physical, bodily pain, and general health domains were averaged to calculate PCS. Total score range for PCS was 0-100 (100=highest level of physical functioning). |
From baseline up to Week 16
|
|
Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline
Časové okno: 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). |
Week 16
|
|
Change From Baseline in Enthesitis Score at Week 16 in Participants With Enthesitis at Baseline
Časové okno: Baseline and 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 scores ranging from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). |
Baseline and Week 16
|
|
Proportion of Participants With Resolution of Dactylitis at Week 16 Among Those With Dactylitis at Baseline
Časové okno: Week 16
|
Dactylitis is characterized by swelling of the entire finger or toe. Presence and severity of dactylitis will be assessed in both hand and feet using a scoring system from 0 to 3 (0: no dactylitis, 1: mild dactylitis, 2: moderate dactylitis, 3: severe dactylitis). The result for each digit are summed to produce a final dactylitis score with a range from 0 to 60. Higher score indicates greater severity. |
Week 16
|
|
Change From Baseline in Dactylitis Score at Week 16 in Participants With Dactylitis at Baseline
Časové okno: From baseline up to Week 16
|
Dactylitis is characterized by swelling of the entire finger or toe. Presence and severity of dactylitis will be assessed in both hand and feet using a scoring system from 0 to 3 (0: no dactylitis, 1: mild dactylitis, 2: moderate dactylitis, 3: severe dactylitis). The result for each digit are summed to produce a final dactylitis score with a range from 0 to 60. Change from baseline in dactylitis score measure the change in dactylitis, where a negative change indicates an improvement and a positive change indicates a worsening. |
From baseline up to Week 16
|
|
Proportion of Participants who Achieved Minimal Disease Activity (MDA) at Week 16
Časové okno: Week 16
|
MDA criteria are a composite of 7 outcome measures used in PsA. Participants are classified as achieving MDA if they fulfill at least 5 out of the 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 percent (%); 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
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 16
Časové okno: From baseline up 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 up to Week 16
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 77242113PSA3002
- 2024-517284-23-00 (Identifikátor registru: EUCT number)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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
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Studuje lékový produkt regulovaný americkým FDA
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