Clinical Trials in Czechia / NCT02808780
Active, not recruiting
Observational
An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
NCT02808780 · tracked via the Priya Life Science Czechia tracker
Condition(s) studied
Ulcerative Colitis
Study summary
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.
Eligibility
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
Primary outcome measure(s)
- Long-term Safety: Participants with Adverse Events of Interest (AEIs) and Serious Adverse Events (AEs) Including Malignancies, Pregnancies, and Non-serious Malignancies — 6 years
Descriptive analysis of serious adverse events, adverse events of interest (including lymphoma \& other malignancies), pregnancies, and non-serious malignancies in participants less than (\<) 30 years of age will be reported.
Trial sites (63)
| Facility | City | Region | Status |
|---|---|---|---|
| — | Murrieta | California | |
| — | Rialto | California | |
| — | Ventura | California | |
| — | Coral Gables | Florida | |
| — | Fort Myers | Florida | |
| — | Lake Worth | Florida | |
| — | Lauderdale Lakes | Florida | |
| — | Miami | Florida | |
| — | Tampa | Florida | |
| — | Suwanee | Georgia | |
| — | Chicago | Illinois | |
| — | Sylvania | Ohio | |
| — | Pittsburgh | Pennsylvania | |
| — | Houston | Texas | |
| — | San Antonio | Texas | |
| — | Lansdowne Town Center | Virginia | |
| — | Salzburg | Austria | |
| — | Sankt Poelten Noe | Austria | |
| — | Vienna | Austria | |
| — | New Westminster | British Columbia | |
| — | Vancouver | British Columbia | |
| — | Oshawa | Ontario | |
| — | Ottawa | Ontario | |
| — | Pilsen | Czechia | |
| — | Clermont-Ferrand | France | |
| — | Clichy | France | |
| — | Créteil | France | |
| — | Grenoble | France | |
| — | Montpellier | France | |
| — | Nice | France | |
| — | Pierre-Bénite | France | |
| — | Saint-Priest-en-Jarez | France | |
| — | Strasbourg | France | |
| — | Berlin | Germany | |
| — | Dessau Roblau | Germany | |
| — | Halle | Germany | |
| — | Hamburg | Germany | |
| — | Heidelberg | Germany | |
| — | Kiel | Germany | |
| — | Leipzig | Germany |
+ 23 more sites — see the full list on the official registry below.
Other trials for the same condition
A Study to Investigate the Efficacy and Safety of Brivekimig in Adult Participants With Ulcerative Colitis
Active, not recruiting
ABTECT - Maintenance
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02808780 on ClinicalTrials.gov ↗ ← All trials in Czechia