Corrona Inflammatory Bowel Disease (IBD) Registry

• ClinicalTrials.gov Identifier: NCT03162549
• Recruitment Status: Enrolling by invitation
• First Posted: May 22, 2017
• Last Update Posted: March 13, 2023
• Sponsor: CorEvitas
• Information provided by (Responsible Party): CorEvitas

Study Description

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.

Condition or disease
Inflammatory Bowel Diseases

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 Design

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 2287 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 15 Years
• Official Title: Corrona Inflammatory Bowel Disease (IBD) Registry
• Actual Study Start Date: March 27, 2017
• Estimated Primary Completion Date: December 2100
• Estimated Study Completion Date: December 2100

Groups and Cohorts

Group/Cohort
Inflammatory Bowel Disease; Pts presenting to enrolling sites across the US are invited to enroll if eligible

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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).

Contacts and Locations

Locations

United States, Massachusetts

Corrona, LLC

Waltham, Massachusetts, United States, 02451

Sponsors and Collaborators

CorEvitas

Investigators

• Study Director: Jeffrey Greenberg, MD; CorEvitas

More Information

Additional Information:

Corrona home page 

• Responsible Party: CorEvitas
• ClinicalTrials.gov Identifier: NCT03162549
• Other Study ID Numbers: Corrona-IBD-600
• First Posted: May 22, 2017
• Last Update Posted: March 13, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Intestinal Diseases; Inflammatory Bowel Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis