Crohn's DiseaseCOMPARENCT04852666
Comparative Effectiveness of Biologics or Small Molecule Therapies in Inflammatory Bowel Disease (IBD)
An observational study of Crohn's Disease and Ulcerative Colitis, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease, Ulcerative Colitis
- How many people
- 465 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Jul 2019to 15 Dec 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Population: participants in IBD Partners or SPARC cohort.
Who may be able to join
- age greater than or equal to 18;
- diagnosis of CD or UC (as reported by participant for IBD Partners registry and/or physician for SPARC-IBD cohort);
- initiated vedolizumab or ustekinumab for CD, or initiated vedolizumab or tofacitinib for UC; treated with anti-TNF prior to vedolizumab/ustekinumab/tofacitinib.
Who cannot join
- less than 18 years of age
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina
Chapel Hill, North Carolina, 27599-7555
Crohn's & Colitis Foundation
New York, New York, 10017
About this study
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
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.
Read the detailed description
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.
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
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 |
|---|---|---|
| Crohn's Disease (Vedolizumab) | Participants with Crohn's disease (CD) who reported taking vedolizumab. | |
| Crohn's Disease (Ustekinumab) | Participants with Crohn's disease (CD) who reported taking ustekinumab. | |
| Ulcerative Colitis (Vedolizumab) | Participants with Ulcerative colitis (UC) who reported taking vedolizumab. | |
| Ulcerative Colitis (Tofacitinib) | Participants with Ulcerative colitis (UC) who reported taking tofacitinib. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PROMIS Measures of Pain Interference
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 (poorer health).
Measured: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
PROMIS Measures of Fatigue
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 (poorer health).
Measured: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
Secondary outcomes (5)
Number of Participants With Index Medication Persistence
Medication persistence was defined as continuing index medication.
Measured: 4-10 months after medication initiation
Number of Participants Using Corticosteroids at Follow-Up
Participants who reported using corticosteroids.
Measured: 4-10 months after medication initiation
Short Crohn's Disease Activity Index (sCDAI)
Short Crohn's Disease Activity Index. This is a method to measure Crohn's disease patients' symptoms using only a questionnaire, which can be completed without an office visit or lab work. The variables included in the short CDAI are abdominal pain, stool frequency, and general well-being reported as a total score. The higher the score, the worse the disease activity. The sCDAI uses the same scale as the full CDAI with scores ranging from 0 to 600, such that scores,<150 define remission, 150 to 219 mild activity, 220 to 450 moderate activity, and greater than 450 severe activity.
Measured: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
Mayo Clinic Score
The Mayo Clinic Score (MCS) asks 2 questions about (1) stool frequency and (2) rectal bleeding with an overall score range (0-6). Higher scores reflect more disease symptomatology.
Measured: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
PROMIS Social Satisfaction Score
NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of social satisfaction. 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 for social satisfaction indicates better health.
Measured: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start25 Jul 2019
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Crohn's and Colitis Foundation
- Responsible party
- Sponsor
- Investigators
- Michael Kappelman, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852666
- Sponsor's protocol ID
- 19-0273
- Other IDs
- PaCR-2017C2-8172-IC
- Acronym
- COMPARE
- Status last verified
- Jan 2024
- First submitted
- 16 Apr 2021
- Last updated
- 14 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04852666
- Acronym / sponsor ID
- COMPARE / 19-0273
- Conditions
- Crohn's Disease, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Crohn's and Colitis Foundation
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Posted 14 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Crohn's Disease (Vedolizumab) | – | –Participants with Crohn's disease (CD) who reported taking vedolizumab. |
| Crohn's Disease (Ustekinumab) | – | –Participants with Crohn's disease (CD) who reported taking ustekinumab. |
| Ulcerative Colitis (Vedolizumab) | – | –Participants with Ulcerative colitis (UC) who reported taking vedolizumab. |
| Ulcerative Colitis (Tofacitinib) | – | –Participants with Ulcerative colitis (UC) who reported taking tofacitinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population: participants in IBD Partners or SPARC cohort.
Key inclusion criteria (3 listed)
- age greater than or equal to 18;
- diagnosis of CD or UC (as reported by participant for IBD Partners registry and/or physician for SPARC-IBD cohort);
- initiated vedolizumab or ustekinumab for CD, or initiated vedolizumab or tofacitinib for UC; treated with anti-TNF prior to vedolizumab/ustekinumab/tofacitinib.
Key exclusion criteria (1 listed)
- less than 18 years of age
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
PROMIS Measures of Pain Interference
Time frame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
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 (poorer health).
PROMIS Measures of Fatigue
Time frame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
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 (poorer health).
5 secondary outcomes
Number of Participants With Index Medication Persistence
Time frame: 4-10 months after medication initiation
Number of Participants Using Corticosteroids at Follow-Up
Time frame: 4-10 months after medication initiation
Short Crohn's Disease Activity Index (sCDAI)
Time frame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
Mayo Clinic Score
Time frame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
PROMIS Social Satisfaction Score
Time frame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Michael Kappelman, MD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease and Ulcerative Colitis, run by University of North Carolina, Chapel Hill at 2 sites 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 3 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: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 14 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
PROMIS Measures of Pain Interference (time frame: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)). The study lists 2 primary outcomes in all. 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 14 Jun 2024.