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Corrona Inflammatory Bowel Disease (IBD) Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03162549
Recruitment Status : Enrolling by invitation
First Posted : May 22, 2017
Last Update Posted : November 17, 2021
Sponsor:
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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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