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Активно (без набиране) Фаза 3 NCT04991116

Long Term Evaluation of Safety and Efficacy of Tildrakizumab in Patients With Psoriatic Arthritis

Фаза 3 – широко изпитване преди одобрение
Заболявания: Psoriatic Arthritis

Спонсор: Sun Pharmaceutical Industries Limited

Налично на: БГ
Обобщение
An open label phase 3 study
Описание
Subjects from both INSPIRE 1 (TILD-19-07) and INSPIRE 2 (TILD-19-19) studies to roll over into this INSPIRE LTE study (TILD-21-01).
Кой може да участва
Inclusion Criteria: * Subjects possess the ability to understand the requirements of the study. * Subject has provided written informed consent as evidenced by signature on an informed consent form approved by an institutional review board/EC. * Agree to abide by the study restrictions, scheduled treatment, laboratory assessments, other study procedures and return to the site for the required assessments. * Subject with PsA who had met all eligibility criteria for the parent study, had completed the parent study treatment period and has not developed any parent protocol criteria for premature discontinuation of treatment or withdrawal from the study. Exclusion Criteria: * Female subjects of childbearing potential who do not agree to abstain from heterosexual activity or practice a dual method of contraception. * Female is pregnant or breastfeeding, or planning to become pregnant or initiate breastfeeding while enrolled in the study or up to 17 weeks after the last dose of IMP. * Subject has previously been enrolled in this long-term extension study. * Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for the subject.
Места на провеждане 14
Австралия (1)
Sunpharma site no 59
Phillip , Australian Capital Territory
Канада (1)
Sunpharma site no 95
Trois-Rivières
Чехия (1)
Sunpharma site no 36
Brno
Estonia (1)
Sunpharma site no 44
Tallinn
Германия (1)
Sunpharma site no 37
Berlin
Индия (1)
Sunpharma site no 92
Surat , Gujarat
Италия (1)
Sunpharma site no 90
Verona
Япония (1)
Sunpharma site no 73
Shinjuku-ku , Tokyo
Полша (1)
Sunpharma site no 43
Bialystok
Словакия (1)
Sunpharma site no 74
Martin
Южна Корея (1)
Sunpharma site no 70
Seoul
Испания (1)
Sunpharma site no 57
A Coruña
Taiwan (1)
Sunpharma site no 76
Kaohsiung City
САЩ (1)
Sunpharma site no 50
Dothan , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
30.06.2022
Крайна дата
01.04.2029
Регистрационен номер
NCT04991116
Източник
anzctr
Запитване за медицински туризъм

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