Comparative Effectiveness of Biologics or Small Molecule Therapies in Inflammatory Bowel Disease (IBD) (COMPARE)
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| ClinicalTrials.gov Identifier: NCT04852666 |
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Recruitment Status :
Enrolling by invitation
First Posted : April 21, 2021
Last Update Posted : April 21, 2021
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Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
Patient-Centered Outcomes Research Institute
Crohn's & Colitis Foundation
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
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Brief Summary:
The purpose of this study is to assess effectiveness of vedolizumab versus ustekinumab in patients with Crohn's disease and vedolizumab versus tofacitinib in patients with ulcerative colitis, after non-response to anti-tumor necrosis factor (TNF) medications, using data from two existing cohorts.
| Condition or disease |
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| Crohn's Disease Ulcerative Colitis |
This study is a secondary analysis using data from participants in the IBD Partners and SPARC-IBD cohorts. Data received from IBD Partners consists of patient-reported outcomes gathered via online surveys (baseline and 6-month follow-ups). Data received from SPARC-IBD consists of patient-reported outcomes gathered via surveys (baseline and follow-ups) as well as data from clinical records.
| Study Type : | Observational |
| Estimated Enrollment : | 900 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Comparative Effectiveness of Biologics or Small Molecule Therapies After Failure of Anti-TNF Treatment in Patients With Crohn's Disease and Ulcerative Colitis |
| Actual Study Start Date : | July 25, 2019 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2021 |
Resource links provided by the National Library of Medicine
| Group/Cohort |
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IBD Partners cohort
IBD Partners is an internet-based cohort study of patients with Crohn's disease (CD) and ulcerative colitis (UC). It is coordinated by the University of North Carolina School of Medicine in conjunction with the Crohn's & Colitis Foundation. There is no intervention for this study.
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SPARC-IBD cohort
SPARC-IBD is a multi-center cohort study of patients with Crohn's disease (CD) and ulcerative colitis (UC). It is coordinated by the Crohn's & Colitis Foundation. There is no intervention for this study.
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Primary Outcome Measures :
- PROMIS measures of pain interference [ Time Frame: 4-10 months after medication initiation ]NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Pain Interference. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more pain interference.
- PROMIS measures of fatigue [ Time Frame: 4-10 months after medication initiation ]NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Fatigue. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more fatigue.
Information from the National Library of Medicine
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| 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
Population: participants in IBD Partners or SPARC cohort.
Criteria
Inclusion Criteria:
- age greater than or equal to 18;
- diagnosis of CD or UC (as reported by participant for IBD Partners and/or physician for SPARC);
- initiated vedolizumab or ustekinumab for CD, or initiated vedolizumab or tofacitinib for UC; treated with anti-TNF prior to vedolizumab/ustekinumab/tofacitinib.
Exclusion Criteria:
- less than 18 years of age
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04852666
Locations
| United States, New York | |
| Crohn's & Colitis Foundation | |
| New York, New York, United States, 10017 | |
| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599-7555 | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Patient-Centered Outcomes Research Institute
Crohn's & Colitis Foundation
Investigators
| Principal Investigator: | Michael Kappelman, MD | University of North Carolina, Chapel Hill |
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT04852666 |
| Other Study ID Numbers: |
19-0273 PaCR-2017C2-8172-IC ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute (PCORI) ) |
| First Posted: | April 21, 2021 Key Record Dates |
| Last Update Posted: | April 21, 2021 |
| Last Verified: | April 2021 |
| 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:
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Crohn Disease Colitis Colitis, Ulcerative Ulcer Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases Colonic Diseases Pathologic Processes |