NCT02808780Active, not recruiting
An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 535 (actual)
- First submitted
- 30 May 2016
- Start date
- 16 Dec 2016
- Primary completion date
- 10 Dec 2026
- Lead sponsor
- Janssen Biotech, Inc.
- Diseases
- Ulcerative colitis
- NCT number
- NCT02808780
What you commit to
- Study type: Observational
- Participants enrolled: 535
- From 16 Dec 2016 to the primary completion date, 10 Dec 2026
- 63 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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:
- The participant is currently receiving Simponi ,or
- The participant is continuing to receive Simponi after participation in an ulcerative colitis study, or
- The participant is scheduled to receive Simponi within 30 days after enrollment
- For Thiopurine cohort:
- The participant is currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry
- Participant must not be receiving other approved biologic agents, including Simponi, or any investigational agents at enrollment
- Participant may have received biologics other than Simponi or investigational agents prior to enrollment
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (63)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.