Corrona Inflammatory Bowel Disease (IBD) Registry

• ClinicalTrials.gov Identifier: NCT03162549
• Recruitment Status: Enrolling by invitation
• First Posted: May 22, 2017
• Last Update Posted: November 17, 2021
• Sponsor: CorEvitas
• Information provided by (Responsible Party): CorEvitas

Tracking Information

• First Submitted Date: May 8, 2017
• First Posted Date: May 22, 2017
• Last Update Posted Date: November 17, 2021
• Actual Study Start Date: March 27, 2017
• Estimated Primary Completion Date: December 2100 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 18, 2017)

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

The major clinical outcomes include an assessment of the epidemiology of Inflammatory Bowel Disease; to better understand the presentation, natural history, management and outcomes.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 18, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Corrona Inflammatory Bowel Disease (IBD) Registry
• Official Title: Corrona Inflammatory Bowel Disease (IBD) Registry
• 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.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 15 Years
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients are enrolled in the Inflammatory Bowel Disease (IBD) Registry during regularly -scheduled office visits. Selected gastroenterologist are invited to participate as investigators in the Registry.
• Condition: Inflammatory Bowel Diseases
• Intervention: Not Provided

Study Groups/Cohorts

Inflammatory Bowel Disease

Pts presenting to enrolling sites across the US are invited to enroll if eligible

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: January 3, 2021): 2287
• Original Estimated Enrollment (submitted: May 18, 2017): 1000
• Estimated Study Completion Date: December 2100
• Estimated Primary Completion Date: December 2100 (Final data collection date for primary outcome measure)

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:

  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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03162549
• Other Study ID Numbers: Corrona-IBD-600
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: CorEvitas
• Original Responsible Party: Same as current
• Current Study Sponsor: CorEvitas
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Jeffrey Greenberg, MD; CorEvitas

• PRS Account: CorEvitas
• Verification Date: January 2021