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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis

Conditions
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Ulcerative Colitis

Participation Criteria
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Eligibility Criteria
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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: 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 Comparator 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Simponi-exposed cohort<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Lymphoma | Incidence was calculated as number of participants with newly diagnosed lymphoma during registry in each cohort. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Risk of Lymphoma (ratio of the rate of lymphoma events in participants in each cohort) | The ratio of the rate of lymphoma events in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi versus thiopurines. | 10 years | 
| Long-term Safety: Participants with Adverse Events of Interest (AEIs) and Serious AEs including malignancies other than lymphoma |  | 10 years | 
| Clinical Disease Status as assessed by Partial Mayo Score | The partial Mayo score, a validated tool used to assess disease status in participants with ulcerative colitis, will be utilized to assess clinical status in this registry. Information will be obtained using 3 of the individual components of the full Mayo score, including stool frequency, rectal bleeding, and PGA (Physician's Global Assessment). Each component score ranges from 0 (normal) to 3 (severe disease) and the score is the sum of those three categories. The total Partial Mayo Score will be calculated as the sum of the scores of all 3 components for each participant that ranges from 0-9. | 10 years | 
| Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Score | The SIBDQ is a disease-specific health-related quality of life (HRQoL) questionnaire, able to detect and define meaningful clinical changes in inflammatory bowel disease (IBD) patients by measuring physical, social and emotional status. The total score ranges from 10 (worst health) to 70 (best health). | 10 years | 
| EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Score | The EQ-5D-5L is a standardized non-disease specific instrument for describing and assessing health-related quality of life.This instrument evaluates 5 areas including mobility, ability for self-care, ability in usual activities, pain/discomfort and anxiety/depression.There also is a self-evaluated 100-point health assessment. | 10 years | 
| Work Productivity and Activity Impairment Questionnaire - Ulcerative Colitis (WPAI-UC) | The WPAI-UC is a validated instrument that measures the effect of ulcerative colitis (UC) symptoms on a patient's life (eg, diarrhea, loss of appetite, weight loss, abdominal pain, fever, joint pain, skin sores, rectal bleeding) and on his or her ability to work and perform regular activities. | 10 years | 
| Treatment Satisfaction Questionnaire for Medication (TSQM) Score | The TSQM is a 14-question instrument that gauges a patient's experience with his or her medication.The questionnaire was designed to evaluate the effectiveness, side effects, and convenience of the medication over a period of 2- to 3-weeks or since the last time it was taken. | 10 years | 
| Health Care Utilization: Evaluate the Number of each Hospitalizations in participants in each cohort |  | 10 years | 
| Health Care Utilization: Evaluate the Reasons for Hospitalization in participants in each cohort |  | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis, Simponi (Golimumab), Thiopurines, Lymphoma, Malignancies