Corrona Inflammatory Bowel Disease (IBD) Registry

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
The objective of the Corrona 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 Corrona 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 Corrona related visits with the Investigator, subjects will be questioned regarding the occurrence of adverse events.

Official Title
-----------------
Corrona Inflammatory Bowel Disease (IBD) Registry

Conditions
-----------------
Inflammatory Bowel Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
ELIGIBILITY CRITERIA∗ To be eligible for enrollment into the Corrona IBD Registry, a patient must satisfy all of the inclusion criteria and none of the exclusion criteria listed below. Inclusion Criteria: 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. Exclusion Criteria: • Participating in or planning to participate in a clinical trial (Phase I - III) or a post-marketing study or registry (i.e. phase IV).∆ Eligible Medications Grouped by Drug Class ANTI-TNF AGENTS AND BIOSIMILARS - Adalimumab (HUMIRA), Adalimumab-atto (AMJEVITA), Certolizumab pegol (CIMZIA), Golimumab (SIMPONI), Infliximab (REMICADE), Infliximab-dyyb (INFLECTRA) INTEGRIN RECEPTOR ANTAGONISTS - Natalizumab (TYSABRI), Vedolizumab (ENTYVIO) INTERLEUKIN ANTAGONIST (IL-12 AND IL-23), Ustekinumab (STELARA), JAK INHIBITOR - Tofacitinib (XELJANZ) SPHINGSOSINE-1-PHOSPHATE RECEPTOR (S1PR) - Ozanimod (ZEPOSIA) ∆ Once clinical trial participation has ended, a patient is permitted to enroll in the registry if they satisfy the eligibility requirements. ∗ These criteria are subject to change with the needs of the registry at the sole discretion of the Sponsor (Corrona).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Inflammatory Bowel Disease<br>Pts presenting to enrolling sites across the US are invited to enroll if eligible | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IBD epidemiology, presentation, natural history, management, and outcomes | The major clinical outcomes include an assessment of the epidemiology of Inflammatory Bowel Disease; to better understand the presentation, natural history, management and outcomes. | Time Frame: A minimum of 10 years from last patient enrolled | 

Secondary Outcome Measures

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