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

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Disease Information

Descriptive Information
Brief Title † An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
Official Title † Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
Brief Summary 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.
Detailed Description 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.
Study Phase N/A
Study Type † Observational
Study Design †
Primary Outcome Measure † Incidence of Lymphoma
Secondary Outcome Measure † Relative Risk of Lymphoma (ratio of the rate of lymphoma events in participants in each cohort)
Condition † Ulcerative Colitis
Intervention †
Study Arms / Comparison Groups Simponi-exposed cohort Participants receiving Simponi at enrollment and are still receiving Simponi after participation in a therapeutic trial or participants scheduled to receive Simponi within 30 days after enrollment. Participants in this cohort may be receiving Simponi alone or in combination with thiopurines but must not be receiving other approved biologics or investigational agents at enrollment. Participants may have received other approved biologics or investigational agents prior to enrollment. comparator cohort Participants currently receiving thiopurines, having received at least 12 consecutive weeks of therapy prior to registry entry. Participants must not be receiving approved biologic agents, including Simponi, or investigational agents at enrollment. These patients may have received biologics other than Simponi or investigational agents prior to enrollment.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status †
Estimated Enrollment † 6000
Start Date † December 16, 2016
Completion Date July 30, 2031
Primary Completion Date July 25, 2031
Eligibility 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
Gender All
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, JNJ.CT@sylogent.com
Location Countries † Austria
Administrative Information
NCT ID † NCT02808780
Organization ID CR105891
Secondary IDs †† CNTO148UCO4001
Responsible Party Sponsor
Study Sponsor † Janssen Biotech, Inc.
Collaborators ††
Investigators † Study Director: Janssen Biotech, Inc. Clinical Trial, Janssen Biotech, Inc.
Information Provided By
Verification Date June 2017
First Received Date † May 30, 2016
Last Updated Date June 13, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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