The purpose of this study is to describe the long-term safety risks in adult participants with moderate-to-severe ulcerative colitis who are treated with Simponi.
Study Type
OBSERVATIONAL
Enrollment
537
Long-term Safety: Participants with Adverse Events of Interest (AEIs) and Serious Adverse Events (AEs) Including Malignancies, Pregnancies, and Non-serious Malignancies
Descriptive analysis of serious adverse events, adverse events of interest (including lymphoma \& other malignancies), pregnancies, and non-serious malignancies in participants less than (\<) 30 years of age will be reported.
Time frame: 6 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.
Time frame: 6 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).
Time frame: 6 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.
Time frame: 6 years
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Unnamed facility
Murrieta, California, United States
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Rialto, California, United States
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Ventura, California, United States
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Coral Gables, Florida, United States
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Fort Myers, Florida, United States
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Lake Worth, Florida, United States
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Lauderdale Lakes, Florida, United States
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Miami, Florida, United States
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Tampa, Florida, United States
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Suwanee, Georgia, United States
...and 53 more locations
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.
Time frame: 6 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.
Time frame: 6 years
Health Care Utilization: Evaluate the Number of Each Hospitalizations in Participants in Each Cohort
Number of hospitalizations in participants in each cohort will be reported.
Time frame: 6 years
Health Care Utilization: Evaluate the Reasons for Hospitalization in Participants in Each Cohort
Reasons for hospitalization in participants in each cohort will be reported.
Time frame: 6 years