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Clinical Trials in the USA / 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 USA tracker
Sponsor
Janssen Biotech, Inc.
Phase
Observational
Started
2016-12-16
Last updated
2026-08-28

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Trial sites (63)

FacilityCityRegionStatus
— 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.

More Janssen Biotech, Inc. trials in the USA

Other trials for the same condition

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 the USA