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

Clinical Trial ID: NCT02808780

Description

The purpose of this study is to compare the incidence of lymphoma in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi versus those treated with thiopurines.

This is an observational prospective long-term exposure registry of adult participants with moderate-to-severe ulcerative colitis. Two cohorts, a Simponi-exposed cohort and a comparator cohort treated with thiopurines, will be enrolled in study. Approximately 6,000 participants are planned for enrollment, with 3,000 participants in the Simponi-exposed cohort and 3,000 participants in the comparator cohort. Participants will receive treatments in a routine clinical setting as prescribed by their physician. After enrollment, during the 10-year follow-up period, a participant may stop his or her ulcerative colitis treatment regimen and switch to a new treatment regimen. Lymphoma incidence will be primarily assessed by a questionnaire that will be sent to the investigator to obtain complete medical information about each case. An expert panel of medical specialists with extensive experience in lymphoma will be convened to validate cases of lymphoma. Besides assessing the incidence of lymphoma, long-term safety will be evaluated by capturing other adverse events of interest and serious adverse events.


Criteria

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 Comparator 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

  • Start Date

    2016-12-16

  • Last Updated

    2020-02-18

  • Sponsor

    Janssen Biotech, Inc.

  • Condition Name

    Ulcerative Colitis

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