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

Official record

Identifier

NCT02808780

Recruiting locations

countries

United StatesAustriaCanadaCzechiaFranceGermanyGreeceSouth KoreaSpain

Interventions studied

Not provided in the official record

Lead sponsor

Janssen Biotech, Inc.

Target enrolment

535 participants

Study type

OBSERVATIONAL

Phase

Not provided in the official record

Status

Active, not recruiting

First posted

Jun 22, 2016

Last updated on the registry

Jul 31, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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