Набор по приглашению NCT03162549

CorEvitas Inflammatory Bowel Disease (IBD) Registry

— Наблюдательное Inflammatory Bowel Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Inflammatory Bowel Diseases. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

This prospective, non-interventional research registry is designed to study the comparative effectiveness and comparative safety of approved treatments for IBD in a cohort of patients cared for by gastroenterologists across North America. Secondary objectives include analyzing the epidemiology and natural history of the disease, its comorbidities, and current treatment practices.

Подробное описание

The objective of the CorEvitas Inflammatory Bowel Diseases (IBD) Registry is to create a national cohort of patients with IBD. The diseases under study include Crohn's Disease (CD) and Ulcerative Colitis (UC). Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of IBD. This will be done through the standardized collection of validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the prevalence and incidence of comorbidities and adverse events, medication utilization patterns, and patient productivity measures.

The design is a prospective, non-interventional registry for patients with IBD under the care of a certified gastroenterologist. Longitudinal follow-up data is collected from both patients and their treating gastroenterologist during routine clinical encounters using CorEvitas registry questionnaires. These questionnaires collect data on patient demographics, disease duration, medical history (including all prior and current treatments for IBD), smoking status, alcohol use, disease activity and severity, pain, as well as other clinician- and patient-reported outcomes, comorbidities and adverse events, infections, hospitalizations, and other targeted safety outcomes.

After the enrollment visit, IBD patients and physicians will complete the follow-up questionnaires during regularly scheduled clinical encounters. The goal is to collect data from patients and providers at six month intervals, not to exceed 2 visits in any 12 month period.

Adverse events may be volunteered spontaneously by the subject, or be discovered as a result of general questioning by the Investigator. During all CorEvitas related visits with the Investigator, subjects will be questioned regarding the occurrence of adverse events.

Первичные конечные точки

IBD epidemiology, presentation, natural history, management, and outcomes [Срок оценки: Time Frame: A minimum of 10 years from last patient enrolled]

Вторичные конечные точки (10)

Disease burden: Harvey-Bradshaw Index [Срок оценки: [Time Frame: every 6 months for 10 years]]
Disease burden: Fistula History [Срок оценки: [Time Frame: every 6 months for 10 years]]
Disease burden: Disease Location and Behavior [Срок оценки: [Time Frame: every 6 months for 10 years]]
Percentage of patients with history of comorbidities [Срок оценки: [Time Frame: time frame: at registry enrollment]]
Physician reported: Pouchitis [Срок оценки: [Time Frame: time frame: every 6 months for 10 years]]
Physician reported: Simple Clinical Colitis Activity Index (SCCAI) [Срок оценки: [Time Frame: time frame: every 6 months for 10 years]]
Physician reported: Mayo Severity Index [Срок оценки: [Time Frame: time frame: every 6 months for 10 years]]
Physician reported: IBD related extraintestinal manifestations [Срок оценки: [Time Frame: time frame: every 6 months for 10 years]]
Patient reported: Patient reported: Work productivity and Activity Impairment (WPAI) [Срок оценки: [Time Frame: time frame: every 6 months for 10 years]]
Patient reported: PROMIS [Срок оценки: [Time Frame: time frame: every 6 months for 10 years]]

Критерии участия

ELIGIBILITY CRITERIA∗ To be eligible for enrollment into the CorEvitas IBD Registry, a patient must satisfy all of the inclusion criteria and none of the exclusion criteria listed below.

Критерии включения

At least 18 years of age or older.
Willing and able to provide written consent for participation in the IBD Registry.
Willing and able to provide Personally Identifiable Information (PII) which includes the following types of personal information at a minimum: full name, date of birth, sex, and home address zip code.
Diagnosis of one of the following by a gastroenterologist:

Crohn's disease
Ulcerative colitis
Prevalent users or new /incident users of an approved biologic drug or JAK inhibitor (Tofacitinib) for the treatment of UC or Crohn's disease.