Corrona Inflammatory Bowel Disease (IBD) Registry

Inflammatory Bowel Diseases Clinical Trial

Official title:

Corrona Inflammatory Bowel Disease (IBD) Registry

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03162549
• Other study ID #: Corrona-IBD-600
• Status: Enrolling by invitation
• Start date: March 27, 2017
• Est. completion date: December 2100

Study information

• Verified date: March 2023
• Source: CorEvitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2287
• Est. completion date: December 2100
• Est. primary completion date: December 2100
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. Crohn's disease

2. 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).

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Locations

Country	Name	City	State
United States	Corrona, LLC	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
CorEvitas

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Corrona home page