Inflammatory Bowel DiseasesNCT03162549
CorEvitas Inflammatory Bowel Disease (IBD) Registry
An observational study of Inflammatory Bowel Diseases, run by CorEvitas at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 2,287 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2017to Dec 2100
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Participating in or planning to participate in a clinical trial (Phase I - III) or a post-marketing study or registry (i.e. phase IV).∆
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
The objective of the CorEvitas 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 CorEvitas 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 CorEvitas related visits with the Investigator, subjects will be questioned regarding the occurrence of adverse events.
- Conditions
- Inflammatory Bowel Diseases
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory Bowel Disease | Pts presenting to enrolling sites across the US are invited to enroll if eligible |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Time Frame: A minimum of 10 years from last patient enrolled
Secondary outcomes (10)
Disease burden: Harvey-Bradshaw Index
Measured: [Time Frame: every 6 months for 10 years]
Disease burden: Fistula History
Measured: [Time Frame: every 6 months for 10 years]
Disease burden: Disease Location and Behavior
Measured: [Time Frame: every 6 months for 10 years]
Percentage of patients with history of comorbidities
Measured: [Time Frame: time frame: at registry enrollment]
Physician reported: Pouchitis
Measured: [Time Frame: time frame: every 6 months for 10 years]
Physician reported: Simple Clinical Colitis Activity Index (SCCAI)
Measured: [Time Frame: time frame: every 6 months for 10 years]
Physician reported: Mayo Severity Index
Measured: [Time Frame: time frame: every 6 months for 10 years]
Physician reported: IBD related extraintestinal manifestations
Measured: [Time Frame: time frame: every 6 months for 10 years]
Patient reported: Patient reported: Work productivity and Activity Impairment (WPAI)
Measured: [Time Frame: time frame: every 6 months for 10 years]
Patient reported: PROMIS
Measured: [Time Frame: time frame: every 6 months for 10 years]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start27 Mar 2017
- Primary completionDec 2100 (estimated)
- Study completionDec 2100 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,287 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- CorEvitas
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jeffrey Greenberg, MD, Study director, CorEvitas, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162549
- Sponsor's protocol ID
- CorEvitas-IBD-600
- Status last verified
- Sep 2025
- First submitted
- 8 May 2017
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CorEvitas Inflammatory Bowel Disease (IBD) Registry
- ClinicalTrials.gov ID
- NCT03162549
- Acronym / sponsor ID
- CorEvitas-IBD-600
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,287 participants (estimated)
- Lead sponsor
- CorEvitasResearch network
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- Dec 2100 (estimated)
- Study completion
- Dec 2100 (estimated)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 CorEvitas 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 CorEvitas 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 CorEvitas related visits with the Investigator, subjects will be questioned regarding the occurrence of adverse events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Bowel Disease | – | –Pts presenting to enrolling sites across the US are invited to enroll if eligible |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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:
- Prevalent users or new /incident users of an approved biologic drug or JAK inhibitor (Tofacitinib) for the treatment of UC or Crohn's disease.
Key exclusion criteria (1 listed)
- Participating in or planning to participate in a clinical trial (Phase I - III) or a post-marketing study or registry (i.e. phase IV).∆
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
10 secondary outcomes
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]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- CorEvitas home pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeffrey Greenberg, MD study director
CorEvitas, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by CorEvitas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBD epidemiology, presentation, natural history, management, and outcomes (time frame: Time Frame: A minimum of 10 years from last patient enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.