Language: BG BG
← Back to results
Active (not recruiting) NCT02808780

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

Conditions: Ulcerative Colitis

Sponsor: Janssen Biotech, Inc.

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 63
Austria (3)
Salzburg
Sankt Poelten Noe
Vienna
Canada (4)
New Westminster , British Columbia
Oshawa , Ontario
Ottawa , Ontario
Vancouver , British Columbia
Czech Republic (1)
Pilsen
France (9)
Clermont-Ferrand
Clichy
Créteil
Grenoble
Montpellier
Nice
Pierre-Bénite
Saint-Priest-en-Jarez
Strasbourg
Germany (11)
Berlin
Dessau Roblau
Halle
Hamburg
Heidelberg
Kiel
Leipzig
Ludwigshafen
Lyneburg
München
Saarbrücken
Greece (4)
Athens
Heraklion
Ioannina
Thessaloniki
South Korea (4)
Busan
Gyeonggi-do
Seongnam-si
Seoul
Spain (11)
A Coruña
Barcelona
Córdoba
Fuenlabrada
Huelva
Madrid
Majadahonda
San Sebastián de los Reyes
Valencia
Vigo
Zaragoza
United States (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
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
16.12.2016
Completion date
11.03.2027
Registry ID
NCT02808780
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.