Registry for patients with Inflammatory Bowel Diseases
CorEvitas Inflammatory Bowel Disease (IBD) Registry
This study is collecting information from patients with Inflammatory Bowel Diseases like Crohn's and Ulcerative Colitis to see how well current treatments are working and to learn more about the disease over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2287 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CorEvitas Research network |
| Drugs / interventions | Tofacitinib |
| Locations | 1 site (Waltham, Massachusetts) |
| Trial ID | NCT03162549 on ClinicalTrials.gov |
What this trial studies
The CorEvitas Inflammatory Bowel Disease (IBD) Registry is a prospective, non-interventional registry aimed at studying the effectiveness and safety of approved treatments for Inflammatory Bowel Diseases, including Crohn's Disease and Ulcerative Colitis. It collects longitudinal data from patients under the care of gastroenterologists across North America through standardized questionnaires that capture patient demographics, disease history, treatment patterns, and outcomes. The registry also aims to analyze the epidemiology and natural history of IBD, including comorbidities and adverse events, to enhance understanding of the disease and treatment practices.
Who should consider this trial
Good fit: Ideal candidates for this registry are adults aged 18 and older diagnosed with Crohn's disease or Ulcerative colitis who are either new or existing users of approved biologic drugs or JAK inhibitors.
Not a fit: Patients currently participating in other clinical trials or post-marketing studies may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the effectiveness and safety of IBD treatments, ultimately improving patient care.
How similar studies have performed: Other observational registries have shown success in providing valuable data on treatment effectiveness and safety, making this approach well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
ELIGIBILITY CRITERIA∗ To be eligible for enrollment into the CorEvitas 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).∆
Where this trial is running
Waltham, Massachusetts
- CorEvitas, LLC — Waltham, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Cathy Cheney
- Email: corevitasregistrytrials@corevitas.com
- Phone: 508-408-5435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.