Inflammatory Bowel DiseasesNCT03633669
Effect of Real-world Tight Control Management of Inflammatory Bowel Disease
A study testing Fecal calprotectin and Routine care in people with Inflammatory Bowel Diseases, run by McMaster University.
Trial summary
Inflammatory bowel disease, which includes Crohn's disease and ulcerative colitis, is a condition that causes inflammation in the gastrointestinal tract. The disease goes through periods of remission and flare. Biomarkers such as fecal calprotectin have been proposed as a tool to monitor disease activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Fecal calprotectin and Routine care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Diagnosis of Crohn's disease or ulcerative colitis based on clinical, endoscopic, radiologic or histologic criteria.
- Followed by a gastroenterologist at Hamilton Health Sciences, St. Joseph's Healthcare Hamilton, and London Health Sciences
- Aged 18 or older
- In clinical remission according to the clinical symptom assessment (Partial Mayo score < 2 or Harvey-Bradshaw Index < 4)
- Currently treated with adalimumab
Who cannot join
- Current abdominal abscess
- Inability or unwillingness to provide informed consent
- Any other condition, which in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study
About this study
Inflammatory bowel disease, which includes Crohn's disease and ulcerative colitis, is a condition that causes inflammation in the gastrointestinal tract. The disease goes through periods of remission and flare. Biomarkers such as fecal calprotectin have been proposed as a tool to monitor disease activity. Fecal calprotectin is a test that measures the amount of inflammation in the stool. Monitoring fecal calprotectin levels can assist gastroenterologists in making decisions regarding patients' IBD treatment such as whether to increase the dose of medications. A recent study showed that frequent measurement of fecal calprotectin every 3 months, also called the tight-control strategy, was associated with improved clinical outcomes in IBD patients. The purpose of this study is to assess whether the tight-control monitoring strategy, which includes fecal calprotectin monitoring every 3 months, improves clinical outcomes in IBD when performed in the real world compared to routine clinical practice.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Fecal calprotectin, Routine care
- 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.
Fecal calprotectinDiagnostic test
Testing every 3 months
Routine careOther
As per treating gastroenterologist
| Study group | Role | What they receive |
|---|---|---|
| Tight control | Active comparator | Group that will receive fecal calprotectin testing every 3 months Receives: Diagnostic Test: Fecal calprotectin |
| Standard care | Placebo comparator | Routine clinical care Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Relapse
This will be a composite outcome of clinical symptom relapse (based on elevation of symptom scores like rise in Harvey Bradshaw Index >=3 points for Crohn's disease and Partial Mayo score >=2 points for ulcerative colitis), hospitalization, prednisone use, or IBD-related surgery
Measured: 12 months
Secondary outcomes (3)
Rate of Clinical symptom relapse
Elevation of symptom scores like rise in Harvey Bradshaw Index >= 3 points for Crohn's disease and Partial Mayo score >=2 points for ulcerative colitis
Measured: 12 months
Incidence of Hospitalizations
Based on admission to hospital for IBD-related reasons
Measured: 12 months
Incidence of change in medical therapies
Increased doses of current biologics, switch to different biologics, addition of immunomodulators, or steroid use would all qualify as changes in medical therapies
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Sep 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Why it stopped: Funding
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.
- More trials run by McMaster UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633669
- Sponsor's protocol ID
- 4
- Status last verified
- Aug 2019
- First submitted
- 27 Jul 2018
- Last updated
- 15 Aug 2019
- 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 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Real-world Tight Control Management of Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03633669
- Acronym / sponsor ID
- 4
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 16 Aug 2018 (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.
Inflammatory bowel disease, which includes Crohn's disease and ulcerative colitis, is a condition that causes inflammation in the gastrointestinal tract. The disease goes through periods of remission and flare. Biomarkers such as fecal calprotectin have been proposed as a tool to monitor disease activity. Fecal calprotectin is a test that measures the amount of inflammation in the stool. Monitoring fecal calprotectin levels can assist gastroenterologists in making decisions regarding patients' IBD treatment such as whether to increase the dose of medications. A recent study showed that frequent measurement of fecal calprotectin every 3 months, also called the tight-control strategy, was associated with improved clinical outcomes in IBD patients. The purpose of this study is to assess whether the tight-control monitoring strategy, which includes fecal calprotectin monitoring every 3 months, improves clinical outcomes in IBD when performed in the real world compared to routine clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tight control | Active comparator | Diagnostic Test: Fecal calprotectinGroup that will receive fecal calprotectin testing every 3 months |
| Standard care | Placebo comparator | Other: Routine careRoutine clinical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Crohn's disease or ulcerative colitis based on clinical, endoscopic, radiologic or histologic criteria.
- Followed by a gastroenterologist at Hamilton Health Sciences, St. Joseph's Healthcare Hamilton, and London Health Sciences
- Aged 18 or older
- In clinical remission according to the clinical symptom assessment (Partial Mayo score < 2 or Harvey-Bradshaw Index < 4)
- Currently treated with adalimumab
Key exclusion criteria (3 listed)
- Current abdominal abscess
- Inability or unwillingness to provide informed consent
- Any other condition, which in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal calprotectinTesting every 3 months | Diagnostic test | Tight control |
| Routine careAs per treating gastroenterologist | Other | Standard care |
Primary outcome
Rate of Relapse
Time frame: 12 months
This will be a composite outcome of clinical symptom relapse (based on elevation of symptom scores like rise in Harvey Bradshaw Index >=3 points for Crohn's disease and Partial Mayo score >=2 points for ulcerative colitis), hospitalization, prednisone use, or IBD-related surgery
3 secondary outcomes
Rate of Clinical symptom relapse
Time frame: 12 months
Incidence of Hospitalizations
Time frame: 12 months
Incidence of change in medical therapies
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal calprotectin and Routine care in people with Inflammatory Bowel Diseases, run by McMaster University.
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of Relapse (time frame: 12 months). 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 15 Aug 2019.