Исследование гуселкумаба у пациентов с активным псориатическим артритом

Название протокола
Клинические исследование Артрит, псориатический: Guselkumab, Плацебо - Реестр клинических исследований
Платное
Нет
Дата начала и окончания КИ
2022-02-06 - 2022-02-06
Спонсоры

Ведущий спонсор: Janssen Research & Development, LLC

Источник Janssen Research & Development, LLC
Краткое содержание

Цель этого исследования - оценить эффективность лечения гуселкумабом у участников. с активным псориатическим артритом (ПсА) уменьшение признаков и симптомов ПсА.

Общий статус Рекрутинг
Дата начала 2021-06-17
Дата завершения 2026-07-01
Дата первичного завершения 2023-12-25
Фаза Фаза 3
Тип исследования Интервенционный
Первичный результат
Мера Временное ограничение
Процент участников, получивших ответ 20 Американского колледжа ревматологии (ACR) на 24 недели IRA-IC en pacientes con EAC estable y comorbilidades. ¿Lo estamos haciendo mejor?
Вторичный результат
Мера Временное ограничение
Change From Baseline in Psoriatic Arthritis (PsA) Modified Van Der Heijde-Sharp (vdH-S) Total Score at Week 24 Baseline and Week 24
Количество участников с нежелательными явлениями (НЯ), серьезными нежелательными явлениями (СНЯ), обоснованно связанными НЯ как мера безопасности и переносимости До 168 недель
Количество участников с НЯ, которые привели к прекращению вмешательства в исследование До 168 недель
Количество участников с инфекциями До 168 недель
Количество участников с НЯ, временно связанными с инфузией, и реакциями в месте инъекции До 168 недель
Количество участников с отклонениями от исходного уровня клинических лабораторных отклонений Исходный уровень, до 168 недель
Количество участников с максимальными общими критериями терминологии для нежелательных явлений (CTCAE) степень токсичности Лабораторные значения До 168 недель
Концентрация гуселкумаба в сыворотке До 168 недель
Количество участников с антителами против гуселькумаба До 168 недель
Регистрация 950
Состояние
  • Артрит, псориатический
Вмешательство

Тип вмешательства: Drug

Название вмешательства: Guselkumab

Описание: Participants will receive guselkumab as SC injection.

Другое имя: CNTO 1959

Тип вмешательства: Препарат, средство, медикамент

Название вмешательства: Плацебо

Описание: Участники получат соответствующее плацебо в виде подкожной инъекции.

Приемлемость

Критерии:

Критерии включения: - У вас есть активный псориатический артрит (ПсА), несмотря на предыдущие небиологические изменения болезни противоревматический препарат (DMARD), апремиласт и / или нестероидный противовоспалительный препарат (НПВП) терапия - иметь диагноз ПсА как минимум за 6 месяцев до первого проведения исследования. агент и соответствуют критериям классификации псориатического артрита (CASPAR) при скрининге - Имеют активный ПсА, определяемый как минимум 3 опухшими суставами и 3 болезненными суставами в скрининг и на исходном уровне; и С-реактивный белок (CRP) больше или равенство (> =) 0,3 миллиграмма на децилитр (мг / дл) при скрининге из лаборатории центральной - На исходных рентгенограммах кистей и стоп имеется> = 2 суставов с эрозиями. определяется центральным чтением - Иметь хотя бы один из следующих подмножеств ПА: дистальный межфаланговый сустав. вовлечение, полиартикулярный артрит без ревматоидных узлов, артрит mutilans, асимметричный периферический артрит или спондилит с периферическим артритом - Имеют активный бляшечный псориаз, по крайней мере, с одной псориатической бляшкой> = 2 сантиметра. (см) диаметр или изменение ногтей, соответствующие псориазу Критерий исключения: - Известна аллергия, гиперчувствительность или непереносимость исследуемого вмешательства или его вспомогательные вещества - Имеет другие воспалительные заболевания, которые могут помешать оценку пользы от терапия гуселкумабом, включая прочего, ревматоидный артрит (РА), аксиальный спондилоартрит (AS) / нерадиографический осевой спондилоартрит (nr-axSpA), системный красная волчанка, или болезнь Лайма - Ранее получал какое-либо биологическое лечение - когда-либо получал тофацитиниб, барицитиниб, филготиниб, пецитиниб, децернотиниб, упадацитиниб или любой другой ингибитор янус-киназы (JAK) - Получал какие-либо иммунодепрессанты (например, азатиоприн, циклоспорин, 6 тиогуанин, меркаптопурин, микофенолят, мофетил, гидроксимочевина, такролимус) в пределах 4 недели после первого введения исследуемого вмешательства

Пол:

Все

Минимальный возраст:

18 лет

Максимальный возраст:

Нет данных

Здоровые волонтеры:

Нет

Общий Официальный
Фамилия Роль Присоединение
Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Общий контакт

Фамилия: Study Contact

Телефон: 844-434-4210

Расположение
Объект: Положение дел:
Rheumatology Associates | Birmingham, Alabama, 35205, United States Recruiting
Arizona Arthritis and Rheumatology Research, PLLC | Flagstaff, Arizona, 86001-6218, United States Recruiting
Arizona Arthritis & Rheumatology Associates PC | Glendale, Arizona, 85306, United States Recruiting
Arizona Arthritis & Rheumatology Research, PLLC | Tucson, Arizona, 85704, United States Recruiting
Advanced Medical Research | La Palma, California, 90623, United States Recruiting
Rheumatology Center of San Diego | San Diego, California, 92128, United States Recruiting
Medvin Clinical Research, Inc. | Whittier, California, 90606, United States Recruiting
The Arthritis Center, Inc. | Palm Harbor, Florida, 34684, United States Recruiting
Forcare Clinical Research, Inc. | Tampa, Florida, 33624, United States Recruiting
Klein & Associates, M.D., P.A. | Hagerstown, Maryland, 21740, United States Recruiting
Arthritis Consultants | Saint Louis, Missouri, 63141, United States Recruiting
Glacier View Research Institute | Kalispell, Montana, 59901-3158, United States Not yet recruiting
NYU Langone Ambulatory Care Brooklyn Heights | Brooklyn, New York, 11201, United States Not yet recruiting
Icahn School of Medicine at Mount Sinai | New York, New York, 10003, United States Withdrawn
PMG Research of Salisbury | Salisbury, North Carolina, 28144, United States Recruiting
STAT Research, Inc. | Dayton, Ohio, 45377, United States Recruiting
Altoona Center For Clinical Research | Duncansville, Pennsylvania, 16635, United States Recruiting
Dr. Ramesh Gupta | Memphis, Tennessee, 38119, United States Recruiting
Austin Regional Clinic | Austin, Texas, 78731, United States Recruiting
Adriana Pop Moody MD Clinic PA | Corpus Christi, Texas, 78404, United States Recruiting
Southwest Rheumatology Research LLC | Mesquite, Texas, 75150, United States Recruiting
Arthritis & Osteoporosis Clinic | Waco, Texas, 76710, United States Recruiting
The Queen Elizabeth Hospital | Adelaide, 5011, Australia Not yet recruiting
Southern Clinical Research | Hobart, 7000, Australia Recruiting
Optimus Research | Kogarah, 2217, Australia Withdrawn
Emeritus Research | Melbourne, 3124, Australia Recruiting
Eastern Health - Box Hill Hospital | Melbourne, 3128, Australia Not yet recruiting
Rheumatology Research Unit | Sunshine Coast, 4558, Australia Recruiting
Republican Research Centre of Radiation Medicine and Human E | Gomel, 246040, Belarus Not yet recruiting
Grodno University Hospital | Grodno, 230017, Belarus Not yet recruiting
City Clinical Hospital #1 | Minsk, 220013, Belarus Withdrawn
2nd City Clinical Hospital | Minsk, 220030, Belarus Not yet recruiting
City Clinical Hospital #9 | Minsk, 220116, Belarus Not yet recruiting
Vitebsk Regional Clinical Hospital | Vitebsk, 210037, Belarus Not yet recruiting
University Clinical center Republic of Srpska | Banja Luka, 78000, Bosnia and Herzegovina Not yet recruiting
Health center Gradiska | Gradiska, 78400, Bosnia and Herzegovina Not yet recruiting
Clinical Center University of Sarajevo | Sarajevo, 71000, Bosnia and Herzegovina Not yet recruiting
University clinic center Tuzla | Tuzla, 75000, Bosnia and Herzegovina Not yet recruiting
UMHAT 'Kaspela' | Plovdiv, 4001, Bulgaria Not yet recruiting
MHAT Trimantium | Plovdiv, 4002, Bulgaria Not yet recruiting
Multiprofile Hospital for Active Treatment - Plovdiv | Plovdiv, 4003, Bulgaria Not yet recruiting
Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv | Plovdiv, 4004, Bulgaria Not yet recruiting
Medical Center 'Teodora' | Ruse, 7003, Bulgaria Not yet recruiting
Medical Center Medconsult-Pleven | Sevlievo, 5400, Bulgaria Recruiting
UMHAT 'Sv. Ivan Rilski' | Sofia, 1431, Bulgaria Not yet recruiting
UMHAT 'St. Ivan Rilski' | Sofia, 1463, Bulgaria Not yet recruiting
DCC XVII-Sofia EOOD | Sofia, 1505, Bulgaria Not yet recruiting
Medical Center Hera EOOD | Sofia, 1510, Bulgaria Recruiting
St Ivan Rilski University Multiprofile Hospital For Active Treatment | Sofia, 1612, Bulgaria Not yet recruiting
Dermatrials Research | Hamilton, Ontario, L8N 1Y2, Canada Withdrawn
Toronto Western Hospital | Toronto, Ontario, M5T2S8, Canada Not yet recruiting
K. Papp Clinical Research | Waterloo, Ontario, N2J 1C4, Canada Withdrawn
Centre de Rhumatologie de l'Est du Quebec | Rimouski, Quebec, G5L 8W1, Canada Not yet recruiting
Centre de Recherche Musculo Squelettique | Trois Rivieres, Quebec, G8Z1Y2, Canada Recruiting
Group De Recherche En Rhumatologie Et Maladies Osseuses | Quebec, G1V 3M7, Canada Recruiting
Ch Osijek | Osijek, 31000, Croatia Not yet recruiting
KBC Rijeka | Rijeka, 51000, Croatia Not yet recruiting
University Hospital Center Split | Split, 21000, Croatia Not yet recruiting
Klinicki bolnicki centar Zagreb | Zagreb, 10000, Croatia Recruiting
Medicinski centar Kuna & Peric | Zagreb, 10000, Croatia Recruiting
University Hospital Sveti Duh | Zagreb, 10000, Croatia Recruiting
Revmacentrum MUDr. Mostera, s.r.o. | Brno - Zidenice, 615 00, Czechia Not yet recruiting
Revmaclinic | Brno, 61141, Czechia Not yet recruiting
Revmatologie s.r.o. | Brno, 656 91, Czechia Recruiting
L.K.N Arthrocentrum | Hlucin, 748 01, Czechia Recruiting
CCBR Ostrava, s.r.o. | Ostrava, 702 00, Czechia Recruiting
MUDr. Rosypalova, s.r.o | Ostrava, 70800, Czechia Not yet recruiting
CCBR Klinicka centra Czech, a.s. | Pardubice, 53002, Czechia Recruiting
Fakultni nemocnice v Motole | Prague, 150 06, Czechia Not yet recruiting
Revmatologicka ambulance | Praha 4, 14000, Czechia Not yet recruiting
Revmatologicky institut | Praha, 12850, Czechia Not yet recruiting
CCR Prague s.r.o. | Praha, 130 00, Czechia Recruiting
Affidea - Praha, s.r.o. | Praha, 14800, Czechia Not yet recruiting
Medical Plus S.R.O. | Uherske Hradiste, 68601, Czechia Recruiting
PV-Medical S.R.O | Zlin, 76001, Czechia Recruiting
OU Innomedica | Tallinn, 10117, Estonia Recruiting
Center for Clinical and Basic Research | Tallinn, 10128, Estonia Withdrawn
East Tallinn Central Hospital | Tallinn, 11312, Estonia Not yet recruiting
North Estonia Medical Centre | Tallinn, 13419, Estonia Not yet recruiting
Sihtasutus Tartu Ulikooli Kliinikum - Nahahaiguste Kliinik | Tartu, 51013, Estonia Recruiting
LTD Clinic LJ | Kutaisi, 4600, Georgia Recruiting
LTD Chemotheraoy and Immunology Clinic MEDULLA | Tbilisi, 0112, Georgia Recruiting
Tbilisi Heart and Vascular Clinic Ltd | Tbilisi, 0159, Georgia Recruiting
LTD MediClub Georgia | Tbilisi, 0160, Georgia Recruiting
LTD MediClub Georgia | Tbilisi, 0160, Georgia Not yet recruiting
Ltd Medicore | Tbilisi, 0186, Georgia Recruiting
Aleksandre Aladashvili Clinic LLC | Tbilisi, 112, Georgia Recruiting
JSC Evex Hospitals | Tbilisi, 159, Georgia Recruiting
LTD The First Medical Center | Tbilisi, 180, Georgia Recruiting
LTD Unimed Kakheti- Telavi Referral Hospital | Telavi, 2200, Georgia Withdrawn
Rheumatologische Schwerpunktpraxis | Berlin, 12161, Germany Not yet recruiting
Praxis Mario Sutowicz | Cottbus, 3042, Germany Withdrawn
Klinikum der Johann Wolfgang Goethe -Universitaet | Frankfurt/Main, 60590, Germany Not yet recruiting
Hamburger Rheuma Forschungszentrum II | Hamburg, 20095, Germany Not yet recruiting
Rheumazentrum Ratingen | Ratingen, 40878, Germany Not yet recruiting
Krankenhaus St. Josef | Wuppertal, 42105, Germany Withdrawn
Revita Rendelő | Budapest, 1027, Hungary Recruiting
Magyar Honvedseg Egeszsegugyi Kozpont | Budapest, 1062, Hungary Recruiting
Qualiclinic Kft | Budapest, H-1036, Hungary Recruiting
Debreceni Egyetem Klinikai Kozpont | Debrecen, 4032, Hungary Not yet recruiting
Pest Megyei Flor Ferenc Korhaz | Kistarcsa, 2143, Hungary Recruiting
Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ | Szeged, 6725, Hungary Not yet recruiting
Csongrád Megyei Dr. Bugyi István Kórház | Szentes, 6600, Hungary Not yet recruiting
MAV Korhaz es Rendelointezet | Szolnok, 5000, Hungary Recruiting
Barzilai Medical Center | Ashkelon, 78278, Israel Not yet recruiting
Bnai Zion Medical Center | Haifa, 31048, Israel Not yet recruiting
Rambam Health Care Campus | Haifa, 3109601, Israel Not yet recruiting
Meir Medical Center | Kfar Saba, 44281, Israel Not yet recruiting
Rabin Medical Center, Beilinson Campus | Petah Tikva, 49100, Israel Not yet recruiting
The Chaim Sheba Medical Center | Ramat Gan, 52621, Israel Not yet recruiting
Tel Aviv Sourasky Medical Center | Tel Aviv, 64239, Israel Not yet recruiting
Ospedale Luigi Sacco, AO-PU | Milano, 20157, Italy Not yet recruiting
AOU Università degli Studi della Campania L. Vanvitelli | Napoli, 80128, Italy Not yet recruiting
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone | Palermo, 90127, Italy Not yet recruiting
Complesso Integrato Columbus | Rome, 00168, Italy Not yet recruiting
A.O.U. Città della Salute e della Scienza | Torino, 10126, Italy Not yet recruiting
M & M Centrs Ltd | Adazi, LV2164, Latvia Recruiting
Daugavpils Regional Hospital | Daugavpils, LV5417, Latvia Withdrawn
P. Stradina Clinical University Hospital | Riga, LV 1002, Latvia Not yet recruiting
Riga 1st Hospital | Riga, LV1001, Latvia Not yet recruiting
J Kisis Ltd | Riga, LV1003, Latvia Recruiting
Orto Clinic Ltd | Riga, LV1005, Latvia Recruiting
Practice Dr Pociene Gilvina | Kaunas, 49476, Lithuania Recruiting
Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik | Kaunas, LT-50161, Lithuania Recruiting
Klaipeda University Hospital | Klaipeda, LT-92288, Lithuania Not yet recruiting
Siauliai Republican Hospital, Public Institution | Siauliai, LT-76231, Lithuania Not yet recruiting
Central Outpatient Clinic | Vilnius, LT01117, Lithuania Not yet recruiting
Angeles University Foundation Medical Center | Angeles, 2009, Philippines Recruiting
Davao Doctors Hospital | Davao City, Philippines Recruiting
Southern Philippines Medical Center | Davao, 8000, Philippines Recruiting
Medical Center Manila | Manila, 1000, Philippines Recruiting
Philippine General Hospital | Manila, 1000, Philippines Recruiting
Osteo-Medic s.c A. Racewicz, J Supronik | Bialystok, 15-351, Poland Recruiting
ClinicMed Badurski i Wspolnicy Spolka Jawna | Bialystok, 15-879, Poland Recruiting
Nasz Lekarz Przychodnie Medyczne | Bydgoszcz, 85-068, Poland Recruiting
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy | Bydgoszcz, 85-168, Poland Not yet recruiting
Ambulatorium Barbara Bazela | Elblag, 82-300, Poland Recruiting
Centrum Kliniczno Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska | Elblag, 82-300, Poland Recruiting
Medica Pro Familia sp. z o.o. S.K.A. | Gdynia, 81-338, Poland Not yet recruiting
Pratia MCM Krakow | Kraków, 30-510, Poland Not yet recruiting
REUMED Zespol Poradni Specjalistycznych Filia nr 2 | Lublin, 20-607, Poland Recruiting
NZOZ Lecznica Mak-Med sc | Nadarzyn, 05-830, Poland Not yet recruiting
Prywatna Praktyka Lekarska, Prof. UM dr hab. med. Paweł Hrycaj | Poznan, 61-397, Poland Not yet recruiting
Nasz Lekarz Przychodnie Medyczne | Torun, 87-100, Poland Recruiting
Medycyna Kliniczna | Warsaw, 00-874, Poland Recruiting
Rheuma-Medicus, Zaklad Opieki Zdrowotnej | Warszawa, 02-118, Poland Recruiting
Reumatika-Centrum Reumatologii, NZOZ | Warszawa, 02-691, Poland Recruiting
DERMMEDICA Sp.z o.o. | Wroclaw, 51-318, Poland Recruiting
Twoja Przychodnia - Centrum Medyczne Nowa Sol | Zielona Gora, 67-100, Poland Not yet recruiting
Chelyabinsk Regional Clinical Dermatovenerological Dispensary | Chelyabinsk, 454092, Russian Federation Not yet recruiting
LLC Aliance Biomedical-Ural group | Izhevsk, 426009, Russian Federation Not yet recruiting
State Budgetary Educational Institution of High Professional Education | Kazan, 420097, Russian Federation Not yet recruiting
Medical Center LLC Maxsimum Zdoroviya | Kemerovo, 644024, Russian Federation Not yet recruiting
City Clinical Hospital #40 | Moscow N/a, 129301, Russian Federation Not yet recruiting
LLC Family Outpatient Clinic # 4 | Moscow, 109044, Russian Federation Recruiting
GAUZ MO Clinical center of restorative medicine and rehabilitation | Moscow, 115419, Russian Federation Not yet recruiting
GUZ of Moscow City Clinical Hospital # 1 n.a.N.I.Pirogov | Moscow, 119049, Russian Federation Not yet recruiting
First Moscow State Medical University n.a. I.M. Sechenov | Moscow, 119991, Russian Federation Not yet recruiting
Botkin City Clinical Hospital | Moscow, 125284, Russian Federation Not yet recruiting
Moscow State Medical and Stomatological University | Moscow, 127473, Russian Federation Not yet recruiting
GU 'Moscow Regional Research Clinical Institute n.a. M.F.Vla | Moscow, 129110, Russian Federation Not yet recruiting
City Clinical Hospital # 20 | Moscow, 129327, Russian Federation Not yet recruiting
FGBU Research Institute of Rheumatology named V.A.Nasonova | Moscow, 190068, Russian Federation Not yet recruiting
LLC Consultative and Diagnostic Center of Rheumatology 'Heal' | Novosibirsk, 630099, Russian Federation Not yet recruiting
GBUZ Orenburg Clinical Regional Hospital | Orenburg, 460000, Russian Federation Not yet recruiting
Republican Hospital n.a.V.A.Baranov | Petrozavodsk, 185019, Russian Federation Not yet recruiting
Ryazan Regional Clinical Dermatovenerological Dispensary | Ryazan, 390000, Russian Federation Not yet recruiting
Ryazan Regional Clinical Cardiology Center | Ryazan, 390026, Russian Federation Not yet recruiting
Ryazan Regional Clinical Hospital | Ryazan, 390026, Russian Federation Not yet recruiting
GUZ Clinical Rheumatological Hospital # 25 | Saint Petersburg, 190068, Russian Federation Not yet recruiting
MedEstetic CentrLab | Saint Petersburg, 192177, Russian Federation Not yet recruiting
Pavlov First Saint Petersburg State Medical University | Saint Petersburg, 197022, Russian Federation Not yet recruiting
North-Western State Medical Unversity n.a Mechnikov | Saint-Petersburg, 195015, Russian Federation Not yet recruiting
LLC Sanavita | Sankt-Petersburg., 195257, Russian Federation Not yet recruiting
Sararov Regional Clinical Hospital | Saratov, 410053, Russian Federation Not yet recruiting
Leningrad Regional Clinical Hospital | St. Petersburg, 194291, Russian Federation Not yet recruiting
Federal North-West Medical Research Centre | St. Petersburg, 195257, Russian Federation Not yet recruiting
Northen-Western State Medical University n.a. I.I. Mechnikov | St.-Petersburg, 191015, Russian Federation Not yet recruiting
OGAUZ Tomsk Regional Clinical Hospital | Tomsk, 634063, Russian Federation Not yet recruiting
Tula Regional Clinical Dermatovenerological Dispensary | Tula, 300053, Russian Federation Not yet recruiting
Ulyanovsk Regional Clinical Hospital | Ulyanovsk, 432063, Russian Federation Not yet recruiting
State Budget Healthcare Institution of Vladimir Region Regional Clinical Hospital | Vladimir, 600023, Russian Federation Not yet recruiting
Vologodskaya Children's regional Clinical hospital | Vologda, 160022, Russian Federation Not yet recruiting
Clinical Emergency Hospital n.a. N.V. Solovyev | Yaroslavl, 150003, Russian Federation Not yet recruiting
Clinical Hospital #3 | Yaroslavl, 150007, Russian Federation Not yet recruiting
State Budget Institution of Health of Yaroslavl region Clinical Hospital No. 10 | Yaroslavl, 150030, Russian Federation Not yet recruiting
Institute of Rheumatology | Belgrade, 11000, Serbia Not yet recruiting
Military Medical Academy | Belgrade, 11000, Serbia Not yet recruiting
Institute for Treatment and Rehabilitation Niska Banja | Niska Banja, 18205, Serbia Not yet recruiting
Institute for Treatment and Rehabilitation Niska Banja | Niska Banja, 18205, Serbia Withdrawn
Special Hospital for Rheumatic Diseases | Novi Sad, 21000, Serbia Not yet recruiting
Splosna bolnisnica Izola | Izo, 6310, Slovenia Not yet recruiting
Bolnica Dr. Petra Drzaja | Ljubljana, Slovenia Not yet recruiting
UKC Maribor Dermatology clinic | Maribor, 2000, Slovenia Not yet recruiting
Hosp. Univ. A Coruña | A Coruna, 15006, Spain Not yet recruiting
Hospital Cima Sanitas | Barcelona, 08034, Spain Withdrawn
Hosp. Reina Sofia | Cordoba, 14004, Spain Not yet recruiting
Hosp. Univ. 12 de Octubre | Madrid, 28041, Spain Not yet recruiting
Hosp. Regional Univ. de Malaga | Málaga, 29009, Spain Not yet recruiting
Complejo Hospitalario Universitario de Santiago. Servicio de Aparato Digestivo | Santiago de Compostela, 15076, Spain Not yet recruiting
Hosp. Clinico Univ. de Santiago | Santiago de Compostela, 15706, Spain Not yet recruiting
Kaohsiung Veterans General Hospital | Kaohsiung, 81362, Taiwan Not yet recruiting
National Taiwan University Hospital | Taipei, 10002, Taiwan Not yet recruiting
Linkou Chang Gung Memorial Hospital | Tao-Yuan, 333, Taiwan Not yet recruiting
Communal Noncommercial Enterprise 'Cherkasy Regional Hospital of Cherkasy Regional Council' | Cherkasy, 18009, Ukraine Not yet recruiting
KLPZ Chernihivska oblasna likarnia, revmatolohichne viddile | Chernihiv, 14029, Ukraine Not yet recruiting
Derzhavna ustanova 'Natsionalnyi instytut terapii imeni L.T.Maloi NAMN Ukrainy' viddil klinichnoi | Kharkiv, 61039, Ukraine Recruiting
Municipal Institution Regional hospital-center of emergency care and disasters medicine | Kharkiv, 61204, Ukraine Not yet recruiting
Khmelnitska oblasna likarnia | Khmelnitsky, 29000, Ukraine Recruiting
TOV Revmocentr | Kiev, 04070, Ukraine Recruiting
Komunalnyi zaklad Kryvorizka miska klinichna likarnia #2 Dnipropetrovskoi oblasnoi rady | Kryvyi Rih, 50056, Ukraine Recruiting
Medical Research and Practice Center Medbud of the Public Joint Stock Holding Company Kyivmiskbud | Kyiv, 03037, Ukraine Recruiting
State Institution Railway clinical Hospital 2 | Kyiv, 03049, Ukraine Not yet recruiting
SI 'National Scientific Center Institute of Cardiology of M.D. Strazhesko' of NAMS of Ukraine | Kyiv, 03680, Ukraine Recruiting
Olexandrivska Clinical Hospital of Kyiv City | Kyiv, 1601, Ukraine Recruiting
Kyivska oblasna klinichna likarnia | Kyiv, 4107, Ukraine Not yet recruiting
Center of Family Medicine Plus LLC | Kyiv, 4210, Ukraine Recruiting
Kyiv Railway Station Clinical Hospital #2 | Kyiv, Ukraine Not yet recruiting
Odeska oblasna klinichna likarnia | Odessa, 65025, Ukraine Not yet recruiting
Multidisciplinary Medical Center of Odessa National Medical University | Odessa, 65026, Ukraine Recruiting
ME 'Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil' | Poltava, 36011, Ukraine Not yet recruiting
Sumska oblasna klinichna likarnia | Sumy, 40031, Ukraine Recruiting
Municipal Non-commercial Enterprise 'Ternopil University Hospital' of Ternopil Regional Council | Ternopil, Ukraine Recruiting
Vinnytska Oblasna klinichna likarnia imeni M.I | Vinnytsia, 21018, Ukraine Withdrawn
Naukovo-doslidnyi inst. Reabilit. Pyrogova [Revmatologichne] | Vinnytsia, 21029, Ukraine Recruiting
Medical Center LTD Health Clinic Department of Cardiology and Rheumatology | Vinnytsya, 21009, Ukraine Recruiting
Zhytomyr Central City Hospital #1 | Zhytomyr, 10002, Ukraine Not yet recruiting
Расположение Страны

Australia

Belarus

Bosnia and Herzegovina

Bulgaria

Canada

Croatia

Czechia

Estonia

Georgia

Germany

Hungary

Israel

Italy

Latvia

Lithuania

Philippines

Poland

Russian Federation

Serbia

Slovenia

Spain

Taiwan

Ukraine

United States

Дата проверки

2021-12-01

Ответственная сторона

Тип: Спонсор

Имеет расширенный доступ Нет
Количество рук 3
Группа вооружений

Метка: Group 1: Guselkumab and Placebo

Тип: Experimental

Описание: Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind. Participants who have not discontinued will be eligible to enter a long-term extension (LTE) and will receive guselkumab and placebo SC. After the study is unblinded to the investigative sites, participants will receive guselkumab and no longer be required to dose with placebo to maintain the blind.

Метка: Группа 2: Гуселькумаб

Тип: Экспериментальный

Описание: Участники получат Гуселькумаб СК. Участники, которые не прекратили участие, будут иметь право на участие в LTE и получат гуселкумаб SC.

Метка: Группа 3: плацебо, за которым следует гуселкумаб

Тип: Экспериментальный

Описание: Участники получат подкожно плацебо и перейдут к получению подкожно гуселкумаба. Участники, которые не прекратили участие, будут иметь право на участие в LTE и получат гуселкумаб SC.

Акроним APEX
Информация о дизайне исследования

Распределение: Рандомизированный

Модель вмешательства: Параллельное присвоение

Первичное назначение: Уход

Маскировка: Двойник (участник, исследователь)