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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02808780
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Janssen Biotech, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Janssen Biotech, Inc. Clinical Trial
Principal Investigator Affiliation	Janssen Biotech, Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Austria, Canada, Czechia, France, Germany, Greece, Italy, Korea, Republic of, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Ulcerative Colitis
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

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UCLA, Los Angeles, California

Status

Withdrawn

Address

UCLA

Los Angeles, California, 90095

Site Contact

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