CorEvitas Inflammatory Bowel Disease (IBD) Registry

NCT03162549 | Enrolling By Invitation

• 1 other identifier: CorEvitas-IBD-600
• Study Type: observational
• Target: 2,287
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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]

Study Arms (1)

Inflammatory Bowel Disease

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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.
• Participating in or planning to participate in a clinical trial (Phase I - III) or a post-marketing study or registry (i.e. phase IV).∆

Sponsors & Collaborators

• CorEvitas: lead

Study Sites (1)

CorEvitas, LLC

Waltham, Massachusetts, 02451, United States

Location

Related Links

• CorEvitas home page

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Jeffrey Greenberg, MD

  CorEvitas, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 15 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 22, 2017
• Study Start: March 27, 2017
• Primary Completion (Estimated): December 1, 2100
• Study Completion (Estimated): December 1, 2100
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)