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Набира участници Фаза 2 NCT07176390

A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014)

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Arthritis, Rheumatoid

Спонсор: Merck Sharp & Dohme LLC

Налично на: БГ
Обобщение
Researchers are looking for new ways to treat rheumatoid arthritis (RA). Methotrexate (MTX) is a standard (usual) treatment for RA. However, MTX and other current treatments may not work well to treat RA symptoms for many people. This study will help find out if a study medicine called tulisokibart can treat symptoms of active RA in people who are taking MTX. In this study, researchers will look at different doses of tulisokibart. Researchers want to learn if at least one of the study doses of tulisokibart works better than a placebo to lessen RA symptoms. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of the study medicine.
Описание
This study consists of a 12-week Placebo-controlled Period and a 116-week Long-term Extension (LTE), which is composed of a 44-week Main Extension and an 72-week Optional Extension
Кой може да участва
Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a clinical diagnosis of rheumatoid arthritis (RA) and fulfillment of 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria * Has active disease defined as ≥6 tender joints (based on 68 joints) and ≥6 swollen joints (based on 66 joints) * Has current treatment with oral or parenteral methotrexate (MTX) therapy * Has history of one of the following: a) biologic disease-modifying antirheumatic drug (bDMARD) naïve, or b) bDMARD-Inadequate Response (IR)/intolerant up to a maximum of 2 classes of bDMARDS Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has any arthritis with onset before age 17 years or current diagnosis of inflammatory joint disease other than RA (such as, but not limited to, psoriatic arthritis, systemic lupus erythematosus, gout, systemic sclerosis, myositis, pseudogout, etc) or any other condition that may, in the judgment of the investigator, interfere with the assessment of RA * Has a history of cancer (except fully treated nonmelanoma skin cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \<5 years before randomization * Has any active infection * Has known allergies, hypersensitivity, or intolerance to tulisokibart or its excipients
Интервенции
Tulisokibart
DRUG
Placebo
DRUG
Methotrexate
DRUG
Места на провеждане 62
Канада (3)
CIUSSS de l'Estrie - CHUS, Hotel-Dieu de Sherbrooke ( Site 1106)
Sherbrooke , Quebec
Study Coordinator
Mount Sinai Hospital ( Site 1102)
Toronto , Ontario
Study Coordinator
Centre de Recherche Musculo-Squelettique ( Site 1101)
Trois-Rivières , Quebec
Study Coordinator
Chile (4)
Centro de Estudios GyC ( Site 1206)
Santiago , Region M. de Santiago
Study Coordinator
Clinica Dermacross ( Site 1203)
Santiago , Region M. de Santiago
Study Coordinator
CECIM ( Site 1208)
Santiago , Region M. de Santiago
Study Coordinator
Pontificia Universidad Catolica de Chile-CICUC ( Site 1209)
Santiago , Region M. de Santiago
Study Coordinator
Китай (8)
Peking University First Hospital ( Site 2511)
Beijing , Beijing Municipality
Study Coordinator
The Third Affiliated Hospital, Sun Yat-sen University ( Site 2514)
Guangzhou , Guangdong
Study Coordinator
Linfen Central Hospital ( Site 2507)
Linfen , Shanxi
Study Coordinator
Taizhou Hospital of Zhejiang Province ( Site 2506)
Linhai , Zhejiang
Study Coordinator
Pingxiang People's Hospital ( Site 2512)
Pingxiang , Jiangxi
Study Coordinator
PEOPLE'S HOSPITAL OF XINJIANG UYGUR AUTONOMOUS REGION ( Site 2515)
Ürümqi , Xinjiang
Study Coordinator
The First Affiliated Hospital of Xiamen University. ( Site 2510)
Xiamen , Fujian
Study Coordinator
Xinxiang Central Hospital ( Site 2501)
Xinxiang , Henan
Study Coordinator
Colombia (3)
Clinica de la Costa S.A.S. ( Site 1301)
Barranquilla , Atlántico
Study Coordinator
CIREEM SAS ( Site 1304)
Bogota , Cundinamarca
Study Coordinator
Fundación Valle del Lili ( Site 1305)
Cali , Valle del Cauca Department
Study Coordinator
Германия (5)
Rheumatologische Schwerpunktpraxis ( Site 1603)
Berlin
Study Coordinator
Rheuma-Research Lausitz ( Site 1604)
Cottbus , Brandenburg
Study Coordinator
HRF II - Hamburger Rheuma Forschungszentrum II MVZ für Rheumatologie und Autoimmunmedizin Hamburg G ( Site 1602)
Hamburg
Study Coordinator
Medicover München Ost MVZ ( Site 1607)
München , Bavaria
Study Coordinator
Rheumazentrum Ratingen Studienambulanz ( Site 1601)
Ratingen , North Rhine-Westphalia
Study Coordinator
Япония (6)
University of Yamanashi Hospital ( Site 2603)
Chūō , Yamanashi
Study Coordinator
Toshin Yoshida Internal Medicine Rheumatology ( Site 2606)
Hanishina-gun , Nagano
Study Coordinator
Kai Clinic ( Site 2600)
Miyazaki
Study Coordinator
Nagaoka Red Cross Hospital ( Site 2604)
Nagaoka , Niigata
Study Coordinator
Sasebo Chuo Hospital ( Site 2602)
Sasebo , Nagasaki
Study Coordinator
Hirose Clinic ( Site 2601)
Tokorozawa , Saitama
Study Coordinator
Полша (7)
MICS Centrum Medyczne Bydgoszcz ( Site 1807)
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
Study Coordinator
Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela-Klnk Reumatologii i Ukladowych Chorob Tkanki Lacznej ( Site 1804)
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
Study Coordinator
NZOZ BIF-MED ( Site 1802)
Bytom , Silesian Voivodeship
Study Coordinator
Zespół Poradni Specjalistycznych Reumed Filia nr 1 Wallenroda ( Site 1801)
Lublin , Lublin Voivodeship
Study Coordinator
MICS Centrum Medyczne Torun ( Site 1803)
Torun , Kuyavian-Pomeranian Voivodeship
Study Coordinator
MICS Centrum Medyczne Warszawa ( Site 1805)
Warsaw , Masovian Voivodeship
Study Coordinator
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji ( Site 1806)
Warsaw , Masovian Voivodeship
Study Coordinator
Южна Корея (3)
Soon Chun Hyang University Cheonan Hospital ( Site 2304)
Cheonan-si , Chungcheongnam-do
Study Coordinator
Chungnam national university hospital ( Site 2303)
Daejeon , Taejon-Kwangyokshi
Study Coordinator
Hanyang University Seoul Hospital ( Site 2300)
Seoul
Study Coordinator
Испания (4)
Hospital Universitari Vall d'Hebron ( Site 1901)
Barcelona
Study Coordinator
Hospital Universitari Parc Tauli ( Site 1900)
Sabadell , Barcelona
Study Coordinator
Hospital Universitario Marqués de Valdecilla ( Site 1906)
Santander , Cantabria
Study Coordinator
Hospital Clinico Universitario de Santiago ( Site 1903)
Santiago de Compostela , La Coruna
Study Coordinator
Великобритания (3)
The Princess Alexandra Hospital NHS Trust ( Site 2103)
Harlow , England
Study Coordinator
Chapel Allerton Hospital ( Site 2106)
Leeds
Study Coordinator
Barnet Hospital ( Site 2102)
London
Study Coordinator
САЩ (16)
Rheumatology Associates ( Site 1026)
Arlington , Texas
Study Coordinator
altoona center for clinical research ( Site 1005)
Duncansville , Pennsylvania
Study Coordinator
Tekton Research, LLC. ( Site 1008)
Fort Collins , Colorado
Study Coordinator
Arizona Arthritis & Rheumatology Associates, P.C. ( Site 1018)
Glendale , Arizona
Study Coordinator
AA Medical Research Center ( Site 1027)
Grand Blanc , Michigan
Study Coordinator
Sweet Hope Research Specialty, Inc ( Site 1015)
Hialeah , Florida
Study Coordinator
Kansas City Physician Partners ( Site 1032)
Kansas City , Missouri
Study Coordinator
Arthritis & Osteoporosis Medical Center - La Palma ( Site 1024)
La Palma , California
Study Coordinator
Physician Research Collaboration, LLC ( Site 1002)
Lincoln , Nebraska
Study Coordinator
AARA Clinical Research - Arizona Arthritis & Rheumatology Associates - Mesa ( Site 1033)
Mesa , Arizona
Study Coordinator
AARA Clinical Research - Murfreesboro Medical Clinic ( Site 1034)
Murfreesboro , Tennessee
Study Coordinator
Greater Chicago Specialty Physicians - Orland Park ( Site 1043)
Orland Park , Illinois
Study Coordinator
HMD Research LLC ( Site 1016)
Orlando , Florida
Study Coordinator
Epic Medical Research ( Site 1004)
Red Oak , Texas
Study Coordinator
Advanced Rheumatology of Houston - Woodlands ( Site 1000)
The Woodlands , Texas
Study Coordinator
Rheumatology Specialty Center ( Site 1030)
Willow Grove , Pennsylvania
Study Coordinator
Технически детайли
Статус
Набира участници
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
80 Years
Здрави доброволци
Не
Начална дата
08.10.2025
Крайна дата
03.09.2029
Регистрационен номер
NCT07176390
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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