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)
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.
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.
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