Tutkimus, jossa arvioidaan rokatinlimabia keskivaikeassa tai vaikeassa atooppisessa ihottumassa (ROCKET-IGNITE) (ROCKET-Ignite)
torstai 25. kesäkuuta 2026 päivittänyt: Amgen
Kolmannen vaiheen, 24 viikon, satunnaistettu, lumekontrolloitu, kaksoissokkotutkimus rotatinlimabin (AMG 451) monoterapian tehon, turvallisuuden ja siedettävyyden arvioimiseksi aikuisilla potilailla, joilla on keskivaikea tai vaikea atooppinen ihottuma (AD)
Tämän tutkimuksen tarkoituksena on arvioida rokatinlimabin tehoa ja turvallisuutta monoterapiassa.
Tutkimuksen yleiskatsaus
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
769
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Born, Alankomaat, 6121 XK
- PreCare Trial and Recruitment
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Buenos Aires
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CABA, Buenos Aires, Argentiina, C1027AAP
- CINME - Centro De Investigaciones Metabolicas
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentiina, C1426ABP
- Fundacion Respirar
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Derqui, Pilar, Buenos Aires, Argentiina, B1629ODT
- Hospital Universitario Austral
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San Miguel, Buenos Aires, Argentiina, 1663
- Centro Dermatologico Schejtman
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Distrito Federal
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Buenos Aires, Distrito Federal, Argentiina, 1425
- Instituto de Neumonología Y Dermatología
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Buenos Aires, Distrito Federal, Argentiina, 1425
- InAER - Investigaciones en Alergia y Enfermedades Respiratorias
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CABA, Distrito Federal, Argentiina, C1012AAY
- Conexa Investigacion Clinica SA
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Santa Fe Province
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Rosario, Santa Fe Province, Argentiina, 2000
- Fundacion Estudios Clinicos
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Rosario, Santa Fe Province, Argentiina, 2000
- Instituto de Diagnostico Abc American British Cowdray
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Rio de Janeiro, Brasilia, 20241-180
- IBPClin Instituto Brasil de Pesquisa Clinica
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São Paulo, Brasilia, 06454-010
- Alergoalfa Nucleo Diagnostico Tratamento e Pesquisa Clinica em Alergia
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilia, 90035-903
- Hospital de Clinicas de Porto Alegre
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Porto Alegre, Rio Grande do Sul, Brasilia, 90160-093
- Hospital Ernesto Dornelles
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São Paulo
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Botucatu, São Paulo, Brasilia, 18618-686
- Upeclin-Pesq Clin FacMed Botucatu
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Santo André, São Paulo, Brasilia, 09060-870
- Fundacao Abc - Centro Univ Fmabc
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Santo André, São Paulo, Brasilia, 09030-010
- Hosp e Maternidade Dr Christovao da Gama
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Sorocaba, São Paulo, Brasilia, 18040-425
- Consultoria Medica e Pesquisa Clinica Cmpc
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Madrid, Espanja, 28006
- Hospital Universitario de La Princesa
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Madrid, Espanja, 28031
- Hospital Universitario Infanta Leonor
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Andalusia
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Córdoba, Andalusia, Espanja, 14004
- Hospital Universitario Reina Sofia
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Aragon
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Zaragoza, Aragon, Espanja, 50009
- Hospital Universitario Miguel Servet
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Canary Islands
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Las Palmas de Gran Canaria, Canary Islands, Espanja, 35010
- Hospital Universitario de Gran Canaria Doctor Negrin
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Catalonia
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Badalona, Catalonia, Espanja, 08916
- Hospital Universitari Germans Trias i Pujol
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L'Hospitalet de Llobregat, Catalonia, Espanja, 08907
- Hospital Universitari de Bellvitge
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Galicia
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Pontevedra, Galicia, Espanja, 36001
- Hospital Clínico Universitario de Santiago
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Madrid
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Pozuelo de Alarcón, Madrid, Espanja, 28223
- Hospital Universitario Quironsalud Madrid
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Valencia
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Valencia, Valencia, Espanja, 46026
- Hospital Universitari i Politecnic La Fe
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Ansansi, Gyeonggido, Etelä -Korea, 15355
- Korea University Ansan Hospital
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Incheon, Etelä -Korea, 21431
- The Catholic University of Korea Incheon St Marys Hospital
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Seoul, Etelä -Korea, 03080
- Seoul National University Hospital
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Seoul, Etelä -Korea, 05505
- Asan Medical Center
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Seoul, Etelä -Korea, 08308
- Korea University Guro Hospital
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Seoul, Etelä -Korea, 04564
- National Medical Center
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Chieti, Italia, 66100
- Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
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Milan, Italia, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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Perugia, Italia, 06156
- Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia
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Roma, Italia, 00161
- Azienda Ospedaliera Policlinico Umberto I
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Torino, Italia, 10126
- Azienda Ospedaliera Citta Della Salute E Della Scienza Di Torino
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Aichi-ken
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Nagakute-shi, Aichi-ken, Japani, 480-1195
- Aichi Medical University Hospital
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Nagoya, Aichi-ken, Japani, 467-8602
- Nagoya City University Hospital
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Nagoya, Aichi-ken, Japani, 464-0821
- Central Clinic
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Nagoya, Aichi-ken, Japani, 457-8510
- Japan Community Healthcare Organization Chukyo Hospital
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Fukuoka
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Fukuoka, Fukuoka, Japani, 819-0373
- Matsuo Clinic
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Fukuoka, Fukuoka, Japani, 814-0180
- Fukuoka University Hospital
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Fukushima
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Fukushima, Fukushima, Japani, 960-1295
- Fukushima Medical University Hospital
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Hokkaido
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Asahikawa-shi, Hokkaido, Japani, 070-8610
- Asahikawa City Hospital
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Ibaraki
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Inashiki-gun, Ibaraki, Japani, 300-0395
- Tokyo Medical University Ibaraki Medical Center
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Ishikawa-ken
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Nonoichi-shi, Ishikawa-ken, Japani, 921-8801
- Kaji Dermatology Clinic
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Iwate
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Morioka, Iwate, Japani, 020-8505
- Iwate Medical University Uchimaru Medical Center
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Kagawa-ken
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Marugame-shi, Kagawa-ken, Japani, 763-0074
- Takeoka Dermatology Clinic
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Kanagawa
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Kawasaki-shi, Kanagawa, Japani, 211-8533
- Nippon Medical School Musashikosugi Hospital
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Kyoto
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Kyoto, Kyoto, Japani, 607-8062
- Rakuwakai Otowa Hospital
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Kyoto, Kyoto, Japani, 602-8566
- University Hospital Kyoto Prefectural University of Medicine
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Osaka
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Izumiotsu-shi, Osaka, Japani, 595-0025
- Mochida Dermatology Clinic
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Tochigi
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Shimotsuga-gun, Tochigi, Japani, 321-0293
- Dokkyo Medical University Hospital
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Tokyo
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Itabashi-ku, Tokyo, Japani, 173-8610
- Nihon University Itabashi Hospital
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Itabashi-ku, Tokyo, Japani, 173-8606
- Teikyo University Hospital
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Alberta
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Edmonton, Alberta, Kanada, T6G 1C3
- Alberta Derma Surgery Centre
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Edmonton, Alberta, Kanada, T6H 4J8
- Vida Clinical Research
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Ontario
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Ajax, Ontario, Kanada, L1S 7K8
- CCA Medical Research Corporation
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Barrie, Ontario, Kanada, L4M 7G1
- SimcoDerm Medical and Surgical Dermatology Centre
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Hamilton, Ontario, Kanada, L8L 3C3
- LEADER research
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Mississauga, Ontario, Kanada, L4Y 4C5
- DermEdge Research Incorporated
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North York, Ontario, Kanada, M3B 3S6
- Gordon Sussman Clinical Research Incorporated
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North York, Ontario, Kanada, M3B 0A7
- Canadian Dermatology Centre
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Richmond Hill, Ontario, Kanada, L4E 4L6
- Oak Ridges Aesthetics Centre
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Quebec
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Montreal, Quebec, Kanada, H2X 2V1
- Innovaderm Research Inc
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Québec, Quebec, Kanada, G1G 3Y8
- Recherche Clinique Sigma Incorporated
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Saskatchewan
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Saskatoon, Saskatchewan, Kanada, S7K 2C1
- Skinsense Medical Research
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Beijing, Kiina, 100044
- Peking University Peoples Hospital
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Shanghai, Kiina, 200443
- Shanghai Skin Disease Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Kiina, 100191
- Peking University Third Hospital
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Beijing, Beijing Municipality, Kiina, 100050
- Beijing Friendship hospital, Capital Medical University
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Fujian
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Fuzhou, Fujian, Kiina, 350000
- The First Affiliated Hospital of Fujian Medical University
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Guangdong
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Guangzhou, Guangdong, Kiina, 510091
- Dermatology Hospital of Southern Medical University
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Guangzhou, Guangdong, Kiina, 510120
- Sun Yat-sen Memorial Hospital Sun Yat-sen university
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Guangzhou, Guangdong, Kiina, 510080
- The First Affiliated Hospital ,Sun-Yat Sen University
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Hebei
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Shijiazhuang, Hebei, Kiina, 050000
- The First Hospital of Hebei Medical University
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Henan
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Nanyang, Henan, Kiina, 473002
- Nanyang First Peoples Hospital
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Sanmenxia, Henan, Kiina, 472099
- Sanmenxia Central Hospital
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Hubei
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Wuhan, Hubei, Kiina, 430022
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
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Hunan
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Changsha, Hunan, Kiina, 410011
- The Second Xiangya Hospital of Central South University
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Jiangsu
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Jiangyin, Jiangsu, Kiina, 214400
- Jiangyin Hospital of Traditional Chinese Medicine
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Wuxi, Jiangsu, Kiina, 241023
- Wuxi Peoples Hospital
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Jiangxi
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Nanchang, Jiangxi, Kiina, 330000
- Dermatology Hospital of Jiangxi Province
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Jilin
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Changchun, Jilin, Kiina, 130021
- The First Hospital of Jilin University
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Liaoning
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Shenyang, Liaoning, Kiina, 110001
- The First Hospital of China Medical University
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Sichuan
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Chengdu, Sichuan, Kiina, 610021
- Chengdu Second Peoples Hospital
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Zhejiang
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Hangzhou, Zhejiang, Kiina, 310003
- The First Affiliated Hospital Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Kiina, 310020
- Affiliated Hangzhou First Peoples Hospital，Zhejiang University School of Medicine
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Hangzhou, Zhejiang, Kiina, 310004
- Zhejiang Provincial Peoples Hospital
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Taizhou, Zhejiang, Kiina, 318000
- Taizhou Central Hospital
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Athens, Kreikka, 12462
- University General Hospital Attikon
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Athens, Kreikka, 11521
- Athens Naval Hospital
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Athens, Kreikka, 16121
- Andreas Syngros Hospital Of Venereal And Dermatological Diseases
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Athens, Kreikka, 11527
- Thoracic General Hospital Of Athens Sotiria
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Ioannina, Kreikka, 45500
- University General Hospital Of Ioannina
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Larissa, Kreikka, 41110
- General University Hospital of Larissa
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Thessaloniki, Kreikka, 56403
- Papageorgiou General Hospital
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Ivanić-Grad, Kroatia, 10310
- Special Hospital for Medical Rehabilitation Naftalan
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Zagreb, Kroatia, 10000
- University Hospital Centre Zagreb
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Zagreb, Kroatia, 10000
- Sestre milosrdnice University Hospital Center
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Riga, Latvia, 1003
- Outpatient clinic Veselibas Centrs 4
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Riga, Latvia, LV-1013
- Outpatient clinic Veselibascentrs 4
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Talsi, Latvia, 3201
- Smite Aija practice in dermatology and venerology
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Lisbon, Portugali, 1998-018
- Hospital CUF Descobertas
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Lisbon, Portugali, 1500-458
- Hospital Lusiadas Lisboa
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Matosinhos Municipality, Portugali, 4464-513
- Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano
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Porto, Portugali, 4099-001
- Unidade Local de Saude de Santo Antonio, EPE - Hospital de Santo Antonio
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San Juan, Puerto Rico, 00909
- Clinical Research of Puerto Rico
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Gdansk, Puola, 80-280
- AKK Medical Spolka z ograniczona odpowiedzialnoscia Centrum Medyczne Tu sie leczy
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Katowice, Puola, 40-611
- Centrum Medyczne Angelius Provita
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Lublin, Puola, 20-080
- Centrum Zdrowia i Urody Maxxmed
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Malbork, Puola, 82-200
- Centrum Badawcze Panaceum Agnieszka Brzezicka Magdalena Lenkiewicz Spzoo
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Nowa Sól, Puola, 67-100
- Twoja Przychodnia NCM
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Poznan, Puola, 61-293
- Twoja Przychodnia PCM
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Szczecin, Puola, 71-500
- Twoja Przychodnia SCM
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Tarnów, Puola, 33-100
- Alergo-Med Specjalistyczna Przychodnia Lekarska Spzoo
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Warsaw, Puola, 02-962
- Royalderm Agnieszka Nawrocka
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Wroclaw, Puola, 50-450
- Dermatologiczna Praktyka Lekarska Michal Torz Dermaceum Centrum Badan Klinicznych
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Berlin, Saksa, 10117
- Charite - Universitaetsmedizin Berlin, Campus Mitte
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Blankenfelde-Mahlow, Saksa, 15831
- Dermatologische Gemeinschaftspraxis-Mahlow
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Bochum, Saksa, 44793
- Hautarztpraxis Dr Niesmann und Dr Othlinghaus
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Darmstadt, Saksa, 64283
- Rosenpark Research GmbH
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Dresden, Saksa, 01307
- Universitaetsklinikum Dresden
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Düsseldorf, Saksa, 40225
- Heinrich-Heine-Universitaet Duesseldorf - Universitaetsklinikum Duesseldorf
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Essen, Saksa, 45174
- Universitaetsklinikum Essen
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Hamburg, Saksa, 20246
- Institute for Health Services Research in Dermatology and Nursing
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Heidelberg, Saksa, 69120
- Universitaetsklinikum Heidelberg
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Stuttgart, Saksa, 70178
- Hautarztpraxis Dres Leitz und Kollegen
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Tübingen, Saksa, 72076
- Universitaetsklinikum Tuebingen
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Wuppertal, Saksa, 42287
- CentroDerm GmbH
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Banská Bystrica, Slovakia, 975 17
- Fakultna Nemocnica s poliklinikou F D Roosevelta Banska Bystrica
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Bratislava, Slovakia, 851 01
- Derma therapy, spol s ro
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Svidník, Slovakia, 089 01
- Sanare spol sro
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Topoľčany, Slovakia, 955 01
- Kaderma Majtan, sro
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Trnava, Slovakia, 917 75
- Fakultna Nemocnica Trnava
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Kaohsiung City, Taiwan, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Tainan, Taiwan, 70403
- National Cheng Kung University Hospital
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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Taipei, Taiwan, 11217
- Taipei Veterans General Hospital
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Taipei, Taiwan, 10449
- MacKay Memorial Hospital Taipei Branch
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Taoyuan, Taiwan, 33305
- Linkou Chang Gung Memorial Hospital
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Náchod, Tšekki, 547 01
- Dermamedica, sro
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Ostrava, Tšekki, 702 00
- CCR Ostrava sro
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Pardubice, Tšekki, 530 02
- Pratia Pardubice as
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Prague, Tšekki, 180 81
- Fakultní nemocnice Bulovka
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Prague, Tšekki, 100 00
- Clintrial sro
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Prague, Tšekki, 130 00
- Pratia Prague sro
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Ústí nad Labem, Tšekki, 401 13
- Krajska zdravotni as - Masarykova nemocnice Usti nad Labem oz
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Veszprém, Unkari, 8200
- MedMare Bt
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Alabama
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Birmingham, Alabama, Yhdysvallat, 35244
- Cahaba Dermatology and Skin Health Center
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Arizona
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Phoenix, Arizona, Yhdysvallat, 85032
- Alliance Dermatology and Mohs Center
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California
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Anaheim, California, Yhdysvallat, 92801
- Anaheim Clinical Trials
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Fountain Valley, California, Yhdysvallat, 92708
- First OC Dermatology
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Glendale, California, Yhdysvallat, 91203
- Kaiser Permanente - Glendale Medical Center
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Long Beach, California, Yhdysvallat, 90805
- Long Beach Research Institute
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Los Angeles, California, Yhdysvallat, 90045
- Dermatology Research Associates
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Los Angeles, California, Yhdysvallat, 90027
- Kaiser Permanente Los Angeles Medical Center
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Sherman Oaks, California, Yhdysvallat, 91403
- Cura Clinical Research
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Colorado
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Centennial, Colorado, Yhdysvallat, 80112
- IMMUNOe Research Centers
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Florida
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Boca Raton, Florida, Yhdysvallat, 33486
- Skin Care Research Incorporated
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Delray Beach, Florida, Yhdysvallat, 33484
- Palm Beach Dermatology Group
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Homestead, Florida, Yhdysvallat, 33030
- Global Research Associates
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Miami, Florida, Yhdysvallat, 33175
- Healthy Life Research
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Miami Lakes, Florida, Yhdysvallat, 33014
- Savin Medical Group LLC
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Naples, Florida, Yhdysvallat, 34102
- Kirsch Dermatology LLC
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Orlando, Florida, Yhdysvallat, 32819
- Pure Skin Dermatology and Aesthetics
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St. Petersburg, Florida, Yhdysvallat, 33709
- Industrial Medicine Associates Ima Clinical Research Inc
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Tampa, Florida, Yhdysvallat, 33606
- Genesis Clinical Research LLC
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Idaho
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Boise, Idaho, Yhdysvallat, 83706
- Treasure Valley Medical Research
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Illinois
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Chicago, Illinois, Yhdysvallat, 60611
- DeNova Research
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West Dundee, Illinois, Yhdysvallat, 60118
- Dundee Dermatology
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Indiana
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Plainfield, Indiana, Yhdysvallat, 46168
- The Indiana Clinical Trials Center PC
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Maryland
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Chevy Chase, Maryland, Yhdysvallat, 20815
- Institute for Asthma and Allergy
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Towson, Maryland, Yhdysvallat, 21204
- Continental Clinical Solutions, LLC
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Michigan
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Detroit, Michigan, Yhdysvallat, 48202
- Henry Ford Health System
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Flint, Michigan, Yhdysvallat, 48532
- Onyx Clinical Research
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Missouri
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Lee's Summit, Missouri, Yhdysvallat, 64064
- Dermatology and Skin Cancer Center of Lees Summit
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Nevada
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Las Vegas, Nevada, Yhdysvallat, 89106
- Jubilee Clinical Research Inc
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New Hampshire
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Portsmouth, New Hampshire, Yhdysvallat, 03801
- Allcutis Research, Llc - Portsmouth
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New Jersey
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Cherry Hill, New Jersey, Yhdysvallat, 08034
- Continental Clinical Solutions - Cherry Hill
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New York
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Hartsdale, New York, Yhdysvallat, 10530
- Industrial Medicine Associates Ima Clinical Research Inc
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New York, New York, Yhdysvallat, 10075
- Sadick Research Group
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North Carolina
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Charlotte, North Carolina, Yhdysvallat, 28277
- Dermatology Specialists of Charlotte
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Charlotte, North Carolina, Yhdysvallat, 28277
- Onsite Clinical Solutions
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Wilmington, North Carolina, Yhdysvallat, 28405
- Wilmington Dermatology Center
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Winston-Salem, North Carolina, Yhdysvallat, 27103
- The Skin Surgery Center for Clinical Research
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Ohio
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Boardman, Ohio, Yhdysvallat, 44512
- Optima Research
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Columbus, Ohio, Yhdysvallat, 43213
- ClinOhio Research Services
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Oklahoma
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Oklahoma City, Oklahoma, Yhdysvallat, 73118
- Unity Clinical Research
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Tulsa, Oklahoma, Yhdysvallat, 74132
- Dermatology Research Center of Oklahoma, PLLC
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Tulsa, Oklahoma, Yhdysvallat, 74137
- Essential Medical Research LLC
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Oregon
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Portland, Oregon, Yhdysvallat, 97239
- Oregon Health and Science University
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Pennsylvania
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Sugarloaf, Pennsylvania, Yhdysvallat, 18249
- DermDox Dermatology, LLC
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Tennessee
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Hermitage, Tennessee, Yhdysvallat, 37076
- Cumberland Skin Center
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Texas
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Dallas, Texas, Yhdysvallat, 75230
- Dermatology Treatment and Research Center PA
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The Woodlands, Texas, Yhdysvallat, 77380
- The Woodlands Dermatology Associates
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Virginia
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Lynchburg, Virginia, Yhdysvallat, 24501
- Education and Research Foundation Inc
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Washington
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Mill Creek, Washington, Yhdysvallat, 98012
- Frontier Derm Partners
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West Virginia
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Morgantown, West Virginia, Yhdysvallat, 26505
- West Virginia Research Institute
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 100 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
Sisällyttämiskriteerit:
- Ikä ≥ 18 vuotta ja AD-diagnoosi AAD-konsensuskriteerien (2014) mukaan vähintään 6 kuukautta
- Aikaisempi riittämätön vaste keskitehoiselle tai tehokkaammalle TCS:lle (paikallinen kortikosteroidi) 6 kuukauden sisällä (paikallisten kalsineuriinin estäjien kanssa tai ilman niitä)
- EASI-pisteet ≥16
- vIGA-AD pisteet ≥3
- ≥10 % kehon pinta-alasta (BSA) AD:n vaikutuksesta
- Pahin kutina numeerinen luokitusasteikko ≥ 4
Poissulkemiskriteerit:
- Hoito biologisella tuotteella 12 viikon tai 5 puoliintumisajan kuluessa, riippuen siitä kumpi on pidempi, ennen päivää 1
Hoito jollakin seuraavista lääkkeistä tai hoidoista 4 viikon tai 5 puoliintumisajan kuluessa, sen mukaan, kumpi on pidempi, ennen päivää 1:
- Systeemiset kortikosteroidit
- Systeemiset immunosuppressantit
- Valohoito
- Janus-kinaasin estäjät
Hoito jollakin seuraavista lääkkeistä tai hoidoista 1 viikon sisällä ennen päivää 1:
- Kaiken tehon TCS
- TCI
- Kutinaa estävä lääke
- Paikalliset fosfodiesteraasin tyypin 4 estäjät
- Muut paikalliset immunosuppressiiviset aineet
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Käsi A
Rokatinlimabiannos 1 4 viikon välein (Q4W) + kyllästysannos viikolla 2
|
Osallistujat saavat Rocatinlimabia ihon alle.
Muut nimet:
|
|
Kokeellinen: Käsivarsi B
Rokatinlimabiannos 2 Q4W + kyllästysannos viikolla 2
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Osallistujat saavat Rocatinlimabia ihon alle.
Muut nimet:
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Placebo Comparator: Käsivarsi C
Plasebo Q4W+ kyllästysannos viikolla 2
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Osallistujat saavat lumelääkettä ihon alle.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Number of Participants Who Achieved Validated Investigator's Global Assessment for AD (vIGA-AD) 1 Response With Presence of Only Barely Perceptible Erythema or vIGA-AD 0 Response (Revised Investigator's Global Assessment [rIGA] 0/1) at Week 24
Aikaikkuna: Baseline and Week 24
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vIGA-AD was a validated instrument rating AD severity on a 5-point scale (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; 4 = Severe), with higher scores indicating greater severity.
Participants achieving a score of 0 or 1 with ≥2-point reduction from baseline were considered 'Clear' or 'Almost clear'.
For rIGA 0/1, when vIGA-AD = 1, investigators answered: "Did participant have barely perceptible erythema, no induration/papulation, no lichenification, and no oozing/crusting?"
If "Yes," the participant met rIGA 0/1; if "No," they did not.
If vIGA-AD = 0, the participant met rIGA 0/1.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Number of Participants Who Achieved ≥ 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 24
Aikaikkuna: Baseline and Week 24
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EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions.
It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification.
The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease.
EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Number of Participants Who Achieved EASI 75 at Week 16
Aikaikkuna: Baseline and Week 16
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EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions.
It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification.
The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease.
EASI 75 was defined as a ≥ 75% reduction from baseline in the total EASI score.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 16
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Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus Numeric Rating Scale (NRS) Score at Week 16 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
Aikaikkuna: Baseline and Week 16
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The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 16
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Number of Participants Who Achieved a ≥ 4-point Reduction From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily Worst Pruritus NRS Score ≥ 4
Aikaikkuna: Baseline and Week 24
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The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Number of Participants Who Achieved ≥ 90% Reduction From Baseline in EASI Score (EASI 90) at Week 24
Aikaikkuna: Baseline and Week 24
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The EASI was designed and widely used to assess the severity and extent of AD across four anatomical regions.
It evaluated key signs of inflammation, including erythema, induration/papulation, excoriation, and lichenification.
The total EASI score ranged from 0 to 72, with higher scores indicating more severe disease.
EASI 90 was defined as a ≥ 90% improvement from baseline in the total EASI score.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Number of Participants Who Achieved a vIGA-AD Score of 0 (Clear) or 1 (Almost Clear) With a ≥ 2-Point Reduction From Baseline (vIGA-AD 0/1) at Week 24
Aikaikkuna: Baseline and Week 24
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The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe.
Higher scores indicated greater disease severity.
Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Number of Participants Who Achieved Facial AD Severity Score of Clear at Week 24 for Participants With Facial AD at Baseline
Aikaikkuna: Baseline and Week 24
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The severity of facial AD was assessed using the Facial AD Severity Scale (FASS).
The FASS was an instrument used to rate the overall severity of facial AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Number of Participants Who Achieved Hand AD Severity Score of Clear at Week 24 for Participants With Hand AD at Baseline
Aikaikkuna: Baseline and Week 24
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The severity of hand AD was assessed using the Hand Atopic Dermatitis Severity Scale (HASS).
The HASS was an instrument used to rate the overall severity of hand AD based on a 5-category scale: clear (0), almost clear (1), mild (2), moderate (3), and severe (4), with higher scores indicating more severe disease.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 16
Aikaikkuna: Baseline and Week 16
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The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (worst observation carried forward [WOCF]) to all subsequent time points.
A negative change from baseline indicated a reduction in itch intensity.
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Baseline and Week 16
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Change From Baseline in Weekly Average of Daily Worst Pruritus NRS Score at Week 24
Aikaikkuna: Baseline and Week 24
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The Worst Pruritus was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of itch.
Participants were asked to rate the intensity of their worst itch using this scale.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in itch intensity.
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Baseline and Week 24
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Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 24 in Participants With Baseline DLQI ≥ 4
Aikaikkuna: Baseline and Week 24
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The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD.
It was designed to measure the health-related quality of life of adult patients suffering from skin disease.
The DLQI measured participants' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Change From Baseline in DLQI Score at Week 24
Aikaikkuna: Baseline and Week 24
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The DLQI was a 10-item, self-administered questionnaire, where the total score ranged from 0 to 30; higher scores represented a greater impact of AD.
It was designed to measure the health-related quality of life of adult patients suffering from skin disease.
The DLQI measured patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the previous week.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the impact of AD on health-related quality of life.
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Baseline and Week 24
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Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Patient Oriented Eczema Measure (POEM) Score at Week 24 in Participants With Baseline POEM Score ≥ 4
Aikaikkuna: Baseline and Week 24
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The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD.
It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Change From Baseline in POEM Score at Week 24
Aikaikkuna: Baseline and Week 24
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The POEM was a 7-item validated questionnaire used to assess disease symptoms in children and adults, where the POEM total score ranged from 0 to 28; higher scores represented a greater impact of AD.
It evaluated the time spent in the past week with AD signs and symptoms: individual items of bleeding, oozing, cracked, flaking, and dry/rough skin, and their impact on sleep.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the impact of AD.
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Baseline and Week 24
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Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24
Aikaikkuna: Baseline and Week 24
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AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in AD skin pain intensity.
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Baseline and Week 24
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Change From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16
Aikaikkuna: Baseline and Week 16
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AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in AD skin pain intensity.
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Baseline and Week 16
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Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
Aikaikkuna: Baseline and Week 24
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AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Number of Participants Who Achieved ≥ 3-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of Daily AD Skin Pain NRS Score ≥ 3
Aikaikkuna: Baseline and Week 16
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AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 16
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Number of Participants Who Achieved HADS-depression Subscale Score < 8 at Week 24 in Participants With Baseline HADS-depression Subscale Score ≥ 8
Aikaikkuna: Baseline and Week 24
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HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-depression subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD.
Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Change From Baseline in HADS-anxiety Subscale Score at Week 24
Aikaikkuna: Baseline and Week 24
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HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-Anxiety subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD.
Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the impact of AD.
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Baseline and Week 24
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Change From Baseline in HADS-depression Subscale Score at Week 24
Aikaikkuna: Baseline and Week 24
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HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-depression subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD.
Depression severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in the impact of AD.
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Baseline and Week 24
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Number of Participants Who Achieved a ≥ 8.7-point Reduction From Baseline in SCORAD Total Score at Week 24 in Participants With Baseline SCORAD Total Score ≥ 8.7
Aikaikkuna: Baseline and Week 24
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The SCORAD total score used to assess the severity of AD using both physician and patient-reported data.
SCORAD total score ranged from 0 to 103 with a higher score indicating more severe AD.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Number of Participants Who Achieved vIGA-AD 0/1 at Week 16
Aikaikkuna: Baseline and Week 16
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The vIGA-AD was a validated assessment instrument used in clinical studies to globally rate the severity of AD on a 5-point scale ranging from 0 to 4, where 0 = Clear, 1 = Almost clear, 2 = Mild, 3 = Moderate, and 4 = Severe.
Higher scores indicated greater disease severity.
Participants who achieved a score of 0 or 1 with a ≥ 2-point reduction from baseline were considered to have achieved 'Clear' or 'Almost clear' status.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 16
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Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 24 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
Aikaikkuna: Baseline and Week 24
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AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Change From Baseline in Severity Scoring (SCORing) of AD (SCORAD) Itch Visual Analogue Scale (VAS) Score at Week 16
Aikaikkuna: Baseline and Week 16
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The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data.
Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in AD severity.
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Baseline and Week 16
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Change From Baseline in SCORAD Itch VAS Score at Week 24
Aikaikkuna: Baseline and Week 24
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The SCORAD Itch VAS was a component of the SCORAD tool used to assess the severity of AD using both physician and patient-reported data.
Itch VAS scale ranged from 0 to 10, with a higher score indicating more severe symptoms of AD.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in AD severity.
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Baseline and Week 24
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Number of Participants Who Achieved ≥ 4-point Reduction From Baseline in Weekly Average of Daily AD Skin Pain NRS Score at Week 16 in Participants With Baseline Weekly Average of AD Skin Pain NRS Score ≥ 4
Aikaikkuna: Baseline and Week 16
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AD skin pain was assessed daily using an NRS consisting of a single item ranging from 0 to 10, where 10 represented the highest intensity of AD skin pain.
Only participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 16
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Change From Baseline in Weekly Average of Daily Sleep Disturbance NRS Score at Week 24
Aikaikkuna: Baseline and Week 24
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Average of Daily Sleep Disturbance NRS Score was defined as the mean of daily scores reported by participants in an electronic diary assessing the quality of their sleep over the past 24 hours.
Sleep disturbance was measured using an NRS consisting of a single item ranging from 0 to 10, where 10 indicated the highest level of sleep disturbance.
Participants were asked to rate the intensity of their sleep disturbance using this scale each day.
Participants initiating rescue therapy for AD were included in the analysis, and each participant's worst observation, including baseline value, before initiation of rescue therapy for AD was carried forward (WOCF) to all subsequent time points.
A negative change from baseline indicated a reduction in level of sleep disturbance.
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Baseline and Week 24
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Number of Participants Who Achieved Hospital Anxiety and Depression Scale (HADS)-Anxiety Subscale Score < 8 at Week 24 in Participants With Baseline HADS-anxiety Subscale Score ≥ 8
Aikaikkuna: Baseline and Week 24
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HADS was defined as a self-assessment questionnaire used to detect states of anxiety and depression in hospital outpatient settings.
The HADS-anxiety subscale score ranged from 0 to 21, with higher scores representing a greater impact of AD.
Anxiety severity was categorized as follows: 0 to 7 (Normal), 8 to 10 (Mild), 11 to 14 (Moderate), and 15 to 21 (Severe).
Participants initiating rescue therapy for AD were classified as nonresponders at all subsequent time points.
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Baseline and Week 24
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Opintojohtaja: MD, Amgen
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- Guttman-Yassky E, Simpson E, Bissonnette R, Eichenfield LF, Kabashima K, Luna PC, Hercogova JT, Spelman L, Worm M, Esfandiari E, Arai T, Mano H, Charuworn P, Wang A, Kricorian G. ROCKET: a phase 3 program evaluating the efficacy and safety of rocatinlimab in moderate-to-severe atopic dermatitis. Immunotherapy. 2025 Feb;17(2):83-94. doi: 10.1080/1750743X.2025.2464528. Epub 2025 Feb 26.
- Guttman-Yassky E, Kabashima K, Worm M, Luna PC, Hong HC, Chovatiya R, Bernstein JA, Kern JS, Ehst BD, Magnolo N, Herranz-Pinto P, Stein Gold L, Sofen H, Pink AE, Esfandiari E, Arai T, Yang Y, Shi R, Barragan C, Kricorian G, Schwartz-Sagi L, Bissonnette R. Efficacy and safety of rocatinlimab for the treatment of moderate-to-severe atopic dermatitis in ROCKET-IGNITE and ROCKET-HORIZON: two global, double-blind, placebo-controlled, randomised phase 3 clinical trials. Lancet. 2026 Jan 3;407(10523):53-66. doi: 10.1016/S0140-6736(25)01865-3. Epub 2025 Nov 25.
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Tiistai 31. toukokuuta 2022
Ensisijainen valmistuminen (Todellinen)
Torstai 28. marraskuuta 2024
Opintojen valmistuminen (Todellinen)
Maanantai 13. tammikuuta 2025
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 24. toukokuuta 2022
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Tiistai 31. toukokuuta 2022
Ensimmäinen Lähetetty (Todellinen)
Keskiviikko 1. kesäkuuta 2022
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Torstai 23. heinäkuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 25. kesäkuuta 2026
Viimeksi vahvistettu
Sunnuntai 1. helmikuuta 2026
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Geneettiset sairaudet, synnynnäiset
- Immuunijärjestelmän sairaudet
- Yliherkkyys, välitön
- Yliherkkyys
- Ihosairaudet
- Ihosairaudet, geneettiset
- Ihosairaudet, eksematoottiset
- Dermatiitti
- Synnynnäiset, perinnölliset ja vastasyntyneiden sairaudet ja poikkeavuudet
- Iho- ja sidekudostaudit
- Dermatiitti, atooppinen
Muut tutkimustunnusnumerot
- 20210142
- 2022-501540-15-00 (Ctis)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
Yksittäisten potilastietojen tunnistaminen poistetuista muuttujista, jotka ovat tarpeen tietyn tutkimuskysymyksen käsittelemiseksi hyväksytyssä tiedonjakopyynnössä.
IPD-jaon aikakehys
Tähän tutkimukseen liittyvät tiedonjakopyynnöt otetaan huomioon 18 kuukauden kuluttua tutkimuksen päättymisestä ja joko 1) tuotteelle ja käyttöaiheelle on myönnetty myyntilupa sekä Yhdysvalloissa että Euroopassa tai 2) tuotteen ja/tai käyttöaiheen kliininen kehitys lopetetaan. eikä tietoja luovuteta valvontaviranomaisille.
Tätä tutkimusta koskevien tietojen jakamispyynnön lähettämiselle ei ole päättymispäivää.
IPD-jaon käyttöoikeuskriteerit
Pätevät tutkijat voivat lähettää pyynnön, joka sisältää tutkimuksen tavoitteet, Amgen-tuotteen (tuotteet) ja Amgen-tutkimuksen/tutkimukset laajuuden, päätepisteet/kiinnostavat tulokset, tilastollisen analyysisuunnitelman, tietovaatimukset, julkaisusuunnitelman ja tutkijan tai tutkijoiden pätevyyden.
Yleisesti ottaen Amgen ei hyväksy yksittäisiä potilastietoja koskevia ulkoisia pyyntöjä, joiden tarkoituksena on arvioida uudelleen tuotemerkinnöissä jo käsiteltyjä turvallisuus- ja tehokysymyksiä.
Pyynnöt käsittelee sisäisten neuvonantajien komitea.
Jos sitä ei hyväksytä, tietojen jakamisesta riippumaton arviointipaneeli ratkaisee ja tekee lopullisen päätöksen.
Hyväksymisen jälkeen tutkimuskysymyksen ratkaisemiseen tarvittavat tiedot toimitetaan tiedonjakosopimuksen ehtojen mukaisesti.
Tämä voi sisältää anonymisoituja yksittäisiä potilastietoja ja/tai saatavilla olevia tukiasiakirjoja, jotka sisältävät analyysikoodin fragmentteja, jos niitä on analyysispesifikaatioissa.
Lisätietoja on alla olevasta URL-osoitteesta.
IPD-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- MAHLA
- ICF
- CSR
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Joo
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Ei
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .