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Активно (без набиране) NCT02808780

An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis

Заболявания: Ulcerative Colitis

Спонсор: Janssen Biotech, Inc.

Налично на: БГ
Обобщение
The purpose of this study is to describe the long-term safety risks in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi.
Кой може да участва
Inclusion Criteria: * Have moderate-to-severe ulcerative colitis of at least 3 months' duration prior to enrollment, confirmed by endoscopy at any time in the past * For enrollment into the Simponi-exposed cohort meets one of the following: 1. The participant is currently receiving Simponi ,or 2. The participant is continuing to receive Simponi after participation in an ulcerative colitis study, or 3. The participant is scheduled to receive Simponi within 30 days after enrollment * For Thiopurine cohort: 1. The participant is currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry 2. Participant must not be receiving other approved biologic agents, including Simponi, or any investigational agents at enrollment 3. Participant may have received biologics other than Simponi or investigational agents prior to enrollment Exclusion Criteria: * Participants who cannot be treated with Simponi or thiopurines * Participants with a previous diagnosis of lymphoma or hematologic malignancy at any time prior to enrollment * Participants currently receiving an investigational or biologic agent other than Simponi * Participants with any condition for which, in the opinion of the investigator, participation in the registry would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments
Места на провеждане 63
Австрия (3)
Salzburg
Sankt Poelten Noe
Vienna
Канада (4)
New Westminster , British Columbia
Oshawa , Ontario
Ottawa , Ontario
Vancouver , British Columbia
Чехия (1)
Pilsen
Франция (9)
Clermont-Ferrand
Clichy
Créteil
Grenoble
Montpellier
Nice
Pierre-Bénite
Saint-Priest-en-Jarez
Strasbourg
Германия (11)
Berlin
Dessau Roblau
Halle
Hamburg
Heidelberg
Kiel
Leipzig
Ludwigshafen
Lyneburg
München
Saarbrücken
Гърция (4)
Athens
Heraklion
Ioannina
Thessaloniki
Южна Корея (4)
Busan
Gyeonggi-do
Seongnam-si
Seoul
Испания (11)
A Coruña
Barcelona
Córdoba
Fuenlabrada
Huelva
Madrid
Majadahonda
San Sebastián de los Reyes
Valencia
Vigo
Zaragoza
САЩ (16)
Chicago , Illinois
Coral Gables , Florida
Fort Myers , Florida
Houston , Texas
Lake Worth , Florida
Lansdowne Town Center , Virginia
Lauderdale Lakes , Florida
Miami , Florida
Murrieta , California
Pittsburgh , Pennsylvania
Rialto , California
San Antonio , Texas
Suwanee , Georgia
Sylvania , Ohio
Tampa , Florida
Ventura , California
Технически детайли
Статус
Активно (без набиране)
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
16.12.2016
Крайна дата
11.03.2027
Регистрационен номер
NCT02808780
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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