Crohn DiseaseHELP-AIDNCT02634060
Home basEd faecaL calProtectin Measurements Predicting Adalimumab Induction Destiny
A study testing Home Based Fecal Calprotectin in people with Crohn Disease and Colitis, Ulcerative, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Recently a smartphone application IBDoc® was developed to enable patients to measure faecal calprotectin at home in an easy way. In this HELP-AID trial we want to evaluate the value of these home based IBDoc® faecal calprotectin measurements in predicting short- and mid-term outcome to ADA induction therapy in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Colitis, Ulcerative
- What is being tested?
- Home Based Fecal Calprotectin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Mar 2016to 5 Sep 2022
- 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
- At least 18 years of age;
- Established diagnosis of UC or CD for at least 3 months, with histopathological confirmation available in the record of the patient;
- Patients having failed steroids or immunomodulatory therapy for at least 3 months, or being intolerant to this therapy;
- Patients should have moderate-to-severe disease at baseline, defined as For CD: an Harvey-Bradshaw-Index above 7 and a C-reactive protein of at least 5 mg/L; For UC: a total Mayo score of at least 6 and an endoscopic sub-score of at least 2;
- Latent tuberculosis excluded within 3 months prior to ADA therapy using Chest X-ray and IFNγ release assay or tuberculin skin test; or adequate treatment for latent tuberculosis initiated for at least four weeks in case of positive screening;
- The patients should have a smartphone and be able to use a new smartphone application;
- Written informed consent must be obtained and documented;
Who cannot join
- Diagnosis of IBD type unclassified (IBDU);
- Previous (procto)colectomy for UC;
- Patients with an ostomy;
- Previous therapy with ADA;
- Patients with CD with a baseline CRP < 5mg/L at baseline;
- Patients with CD and absence of luminal disease;
Show all 11Show fewer
- Patient with UC lacking faecal blood loss (Mayo bleeding score 0);
- Patients with UC with an ileal pouch-anal or ileo-rectal anastomosis
- Patients with acute severe IV steroid refractory colitis;
- Patients with any condition that would prevent completion of the study including history of drug or alcohol abuse, history of mental illness, or history of noncompliance with treatments or visits;
- Patients with absolute or relative contraindications for anti-TNF therapy, including intra-abdominal collections, symptomatic strictures, demyelinating disease, heart failure, …;
Trial locations and contacts
1 site in 1 country.
About this study
Recently a smartphone application IBDoc® was developed to enable patients to measure faecal calprotectin at home in an easy way. In this HELP-AID trial we want to evaluate the value of these home based IBDoc® faecal calprotectin measurements in predicting short- and mid-term outcome to ADA induction therapy in patients with moderate-to-severe IBD.
Patients known with moderate-to-severe CD and ulcerative colitis starting ADA therapy will be asked to participate in this study. They will be asked to collect a stool sample at 3 different time points (week 0, 4 and 8). This faecal sample needs to be loaded on a test cassette with an extraction device. In a second step, the patient can turn his smartphone into an easy to use test cassette reader by taking a picture and using the CalApp® which is based on an immunochromatographic test. Finally, the CalApp® will transmit the test results securely to the health care professional.
In this study we want to evaluate the predictive value of absolute and relative faecal calprotectin values measured by IBDoc® on clinical, biological and endoscopic outcome at week 12. Furthermore, we want to evaluate the correlation between IBDoc® and classical ELISA measurements of faecal calprotectin, and the convenience of this system to the patient and the health care professional.
Read the detailed description
Adalimumab (Humira®), a fully human monoclonal antibody to TNF, has been given an important position in the treatment of patients with an inflammatory bowel disease (IBD). However, not all patients respond adequately to this relatively expensive and potentially toxic therapy. Adapting the standard treatment regimen to the individual needs of the patient may favor the short and long term outcome of this therapy.
Following daily clinical practice, patients will receive standard induction therapy with 160 mg adalimumab at week 0, followed by 80 mg adalimumab at week 2. Starting at week 4 patients will receive a maintenance therapy with 40 mg adalimumab every other week. If a patient shows an insufficient response, the dose can be increased to 40 mg adalimumab every week.
Defining predictors of response to ADA has become a major objective in scientific research. One of the predictors of response may be an early decrease in faecal calprotectin. Faecal calprotectin is a protein which presence in the stool of a patient correlates with endoscopic disease activity. A persistently elevated faecal calprotectin after start up with adalimumab treatment may suggest that this patient needs a higher dose.
Recently a smartphone application IBDoc® was developed to enable patients to measure faecal calprotectin at home in an easy way. In this HELP-AID trial we want to evaluate the value of these home based IBDoc® faecal calprotectin measurements in predicting short- and mid-term outcome to ADA induction therapy in patients with moderate-to-severe IBD.
Patients known with moderate-to-severe CD and ulcerative colitis starting ADA therapy will be asked to participate in this study. They will be asked to collect a stool sample at 3 different time points (week 0, 4 and 8). This faecal sample needs to be loaded on a test cassette with an extraction device. In a second step, the patient can turn his smartphone into an easy to use test cassette reader by taking a picture and using the CalApp® which is based on an immunochromatographic test. Finally, the CalApp® will transmit the test results securely to the health care professional.
In this study we want to evaluate the predictive value of absolute and relative faecal calprotectin values measured by IBDoc® on clinical, biological and endoscopic outcome at week 12. Furthermore, we want to evaluate the correlation between IBDoc® and classical ELISA measurements of faecal calprotectin, and the convenience of this system to the patient and the health care professional.
- Conditions
- Crohn Disease, Colitis, Ulcerative
- Being tested
- Home Based Fecal Calprotectin
- Keywords
- adalimumab, fecal calprotectin, home based
- 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.
Home Based Fecal CalprotectinDevice
Also called IBDoc
Home Based Fecal Calprotectin measurement at weeks 0, 4 and 8
| Study group | Role | What they receive |
|---|---|---|
| Home Based Fecal Calprotectin | Experimental | IBDoc® at week 0, 4 and 8 using smartphone. All material will be provided by the third party The same stool sample of the home base faecal calprotectin will be brought to the hospital and used for ELISA faecal calprotectin measurement at week 0, 4 and 8 for UC patients and week 0 and 4 for CD patients.
IBDoc® results will be forwarded to the patient and the health care professional. Receives: Device: Home Based Fecal Calprotectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
In UC: Steroid-free mucosal healing (Mayo 0 or 1) at week 8 without prior need for ADA dose optimization, taking into account all kind of topical and systemic steroids.
The predictive value of an early faecal calprotectin amelioration (EFCA) measured by IBDoc between baseline and week 4, in predicting steroid-free mucosal healing (Mayo 0 or 1) at week 8 without prior need for ADA dose optimization, taking into account all kind of topical and systemic steroids. EFCA is defined as a decrease in faecal calprotectin measured by IBDoc between baseline and week 4 with at least 80% or a faecal calprotectin less than 50 μg/g at week 4.
Measured: Week 8
In CD: Steroid-free clinical remission at week 12, defined as an Harvey-Bradshaw-Index <5 and a C-reactive protein <5 mg/L, without prior need for ADA dose optimization and taking into account all kind of topical and systemic steroids
The predictive value of EFCA measured by IBDoc® between baseline and week 4, in predicting steroid-free clinical remission at week 12 , defined as an Harvey-Bradshaw-Index <5 and a C-reactive protein <5 mg/L, without prior need for ADA dose optimization and taking into account all kind of topical and systemic steroids. EFCA is defined as a decrease in faecal calprotectin measured by IBDoc® between baseline and week 4 with at least 80% or a faecal calprotectin less than 50 μg/g at week 4.
Measured: Week 12
Secondary outcomes (6)
In UC: The predictive value of an absolute and relative faecal calprotectin measured by IBDoc® between baseline and week 4
The predictive value of an absolute and relative faecal calprotectin measured by IBDoc® between baseline and week 4 in predicting:
- steroid-free complete mucosal healing (Mayo 0) at week 8, and week 26, without prior need for ADA dose optimization;
- steroid-free mucosal healing (Mayo 0 or 1) at week 26, without prior need for ADA dose optimization;
- steroid-free clinical response (decrease from baseline in the total Mayo score ≥3 and ≥30% with a decrease in the rectal bleeding sub-score of ≥1 point or an absolute rectal bleeding sub-score 0 or 1) at week 8, week 12, and week 26, without prior need for ADA dose optimization;
- steroid-free clinical remission (Mayo ≤2, no individual sub-score >1) at week 8, week 12, and week 26, without prior need for ADA dose optimization;
- ADA treatment optimization;
- ADA treatment discontinuation;
Measured: 4 weeks
In UC: The predictive value of an absolute and relative faecal calprotectin measured by IBDoc® between baseline and week 8
The predictive value of an absolute and relative faecal calprotectin measured by IBDoc® between baseline and week 8 in predicting:
- steroid-free complete mucosal healing (Mayo 0) at week 26, without prior need for ADA dose optimization;
- steroid-free mucosal healing (Mayo 0 or 1) at week 26, without prior need for ADA dose optimization;
- steroid-free clinical response (decrease from baseline in the total Mayo score ≥3 and ≥30% with a decrease in the rectal bleeding sub-score of ≥1 point or an absolute rectal bleeding sub-score 0 or 1) at week 12, and week 26, without prior need for ADA dose optimization;
- steroid-free clinical remission (Mayo ≤2, no individual sub-score >1) at week 12, and week 26, without prior need for ADA dose optimization;
- ADA treatment optimization;
- ADA treatment discontinuation;
Measured: 8 weeks
In CD: The predictive value of an absolute and relative faecal calprotectin measured by IBDoc® between baseline and week 4
The predictive value of an absolute and relative faecal calprotectin measured by IBDoc® between baseline and week 4 in predicting:
- steroid-free clinical-remission at week 26, without prior need for ADA dose optimization;
- steroid-free clinical response (HBI <5 or drop in HBI with ≥3) at week 12, and week 26, without prior need for ADA dose optimization;
- steroid-free biological remission (CRP <5 mg/L) at week 12, and week 26, without prior need for ADA dose optimization;
- steroid-free biological response (CRP <5 mg/L or drop with ≥50%) at week 12, and week 26;
- ADA treatment optimization;
- ADA treatment discontinuation;
Measured: 4 weeks
In CD: The predictive value of an absolute and relative faecal calprotectin measured by IBDoc® between baseline and week 8
The predictive value of an absolute and relative faecal calprotectin measured by IBDoc® between baseline and week 8 in predicting:
- steroid-free clinical remission at week 26, without prior need for ADA dose optimization;
- steroid-free clinical response (HBI <5 or drop in HBI with ≥3) at week 12, and week 26, without prior need for ADA dose optimization;
- steroid-free biological remission (CRP <5 mg/L) at week 12, and week 26, without prior need for ADA dose optimization;
- steroid-free biological response (CRP <5 mg/L or drop with ≥50%) at week 12, and week 26, without prior need for ADA dose optimization;
- ADA treatment optimization;
- ADA treatment discontinuation;
Measured: 8 weeks
In UC and CD: correlations with IBDoc® measurements of faecal calprotectin and ELISA measurements of faecal calprotectin, different components of the Mayo score, C reactive protein and serum albumin
The correlation between IBDoc® measurements of faecal calprotectin, ELISA measurements of faecal calprotectin, different components of the Mayo score, C reactive protein and serum albumin, at weeks 0, 4, 8, 12 and 26;
Measured: 26 weeks
In UC and CD: The convenience of the IBDoc® system to the patient and the health care professional
The convenience of the IBDoc® system for patients, and health care professionals
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study start31 Mar 2016
- Primary completion1 Jun 2018
- Study completion5 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
- Responsible party
- Sponsor
- Investigators
- Marc Ferrante, MD PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634060
- Sponsor's protocol ID
- S58392
- Acronym
- HELP-AID
- Status last verified
- Oct 2017
- First submitted
- 14 Dec 2015
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home basEd faecaL calProtectin Measurements Predicting Adalimumab Induction Destiny
- ClinicalTrials.gov ID
- NCT02634060
- Acronym / sponsor ID
- HELP-AID / S58392
- Conditions
- Crohn Disease, Colitis, Ulcerative
- Keywords
- adalimumab, fecal calprotectin, home based
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
- Study start
- 31 Mar 2016
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 5 Sep 2022 (actual)
- First posted
- 17 Dec 2015 (estimated)
- 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.
Recently a smartphone application IBDoc® was developed to enable patients to measure faecal calprotectin at home in an easy way. In this HELP-AID trial we want to evaluate the value of these home based IBDoc® faecal calprotectin measurements in predicting short- and mid-term outcome to ADA induction therapy in patients with moderate-to-severe IBD.
Patients known with moderate-to-severe CD and ulcerative colitis starting ADA therapy will be asked to participate in this study. They will be asked to collect a stool sample at 3 different time points (week 0, 4 and 8). This faecal sample needs to be loaded on a test cassette with an extraction device. In a second step, the patient can turn his smartphone into an easy to use test cassette reader by taking a picture and using the CalApp® which is based on an immunochromatographic test. Finally, the CalApp® will transmit the test results securely to the health care professional.
In this study we want to evaluate the predictive value of absolute and relative faecal calprotectin values measured by IBDoc® on clinical, biological and endoscopic outcome at week 12. Furthermore, we want to evaluate the correlation between IBDoc® and classical ELISA measurements of faecal calprotectin, and the convenience of this system to the patient and the health care professional.
Detailed description
Adalimumab (Humira®), a fully human monoclonal antibody to TNF, has been given an important position in the treatment of patients with an inflammatory bowel disease (IBD). However, not all patients respond adequately to this relatively expensive and potentially toxic therapy. Adapting the standard treatment regimen to the individual needs of the patient may favor the short and long term outcome of this therapy.
Following daily clinical practice, patients will receive standard induction therapy with 160 mg adalimumab at week 0, followed by 80 mg adalimumab at week 2. Starting at week 4 patients will receive a maintenance therapy with 40 mg adalimumab every other week. If a patient shows an insufficient response, the dose can be increased to 40 mg adalimumab every week.
Defining predictors of response to ADA has become a major objective in scientific research. One of the predictors of response may be an early decrease in faecal calprotectin. Faecal calprotectin is a protein which presence in the stool of a patient correlates with endoscopic disease activity. A persistently elevated faecal calprotectin after start up with adalimumab treatment may suggest that this patient needs a higher dose.
Recently a smartphone application IBDoc® was developed to enable patients to measure faecal calprotectin at home in an easy way. In this HELP-AID trial we want to evaluate the value of these home based IBDoc® faecal calprotectin measurements in predicting short- and mid-term outcome to ADA induction therapy in patients with moderate-to-severe IBD.
Patients known with moderate-to-severe CD and ulcerative colitis starting ADA therapy will be asked to participate in this study. They will be asked to collect a stool sample at 3 different time points (week 0, 4 and 8). This faecal sample needs to be loaded on a test cassette with an extraction device. In a second step, the patient can turn his smartphone into an easy to use test cassette reader by taking a picture and using the CalApp® which is based on an immunochromatographic test. Finally, the CalApp® will transmit the test results securely to the health care professional.
In this study we want to evaluate the predictive value of absolute and relative faecal calprotectin values measured by IBDoc® on clinical, biological and endoscopic outcome at week 12. Furthermore, we want to evaluate the correlation between IBDoc® and classical ELISA measurements of faecal calprotectin, and the convenience of this system to the patient and the health care professional.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home Based Fecal Calprotectin | Experimental | Device: Home Based Fecal CalprotectinIBDoc® at week 0, 4 and 8 using smartphone. All material will be provided by the third party The same stool sample of the home base faecal calprotectin will be brought to the hospital and used for ELISA faecal calprotectin measurement at week 0, 4 and 8 for UC patients and week 0 and 4 for CD patients. IBDoc® results will be forwarded to the patient and the health care professional. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age;
- Established diagnosis of UC or CD for at least 3 months, with histopathological confirmation available in the record of the patient;
- Patients having failed steroids or immunomodulatory therapy for at least 3 months, or being intolerant to this therapy;
- Patients should have moderate-to-severe disease at baseline, defined as For CD: an Harvey-Bradshaw-Index above 7 and a C-reactive protein of at least 5 mg/L; For UC: a total Mayo score of at least 6 and an endoscopic sub-score of at least 2;
- Latent tuberculosis excluded within 3 months prior to ADA therapy using Chest X-ray and IFNγ release assay or tuberculin skin test; or adequate treatment for latent tuberculosis initiated for at least four weeks in case of positive screening;
Key exclusion criteria (11 listed)
- Diagnosis of IBD type unclassified (IBDU);
- Previous (procto)colectomy for UC;
- Patients with an ostomy;
- Previous therapy with ADA;
- Patients with CD with a baseline CRP < 5mg/L at baseline;
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 |
|---|---|---|
| Home Based Fecal CalprotectinAlso: IBDocHome Based Fecal Calprotectin measurement at weeks 0, 4 and 8 | Device | Home Based Fecal Calprotectin |
Primary outcome
In UC: Steroid-free mucosal healing (Mayo 0 or 1) at week 8 without prior need for ADA dose optimization, taking into account all kind of topical and systemic steroids.
Time frame: Week 8
The predictive value of an early faecal calprotectin amelioration (EFCA) measured by IBDoc between baseline and week 4, in predicting steroid-free mucosal healing (Mayo 0 or 1) at week 8 without prior need for ADA dose optimization, taking into account all kind of topical and systemic steroids. EFCA is defined as a decrease in faecal calprotectin measured by IBDoc between baseline and week 4 with at least 80% or a faecal calprotectin less than 50 μg/g at week 4.
In CD: Steroid-free clinical remission at week 12, defined as an Harvey-Bradshaw-Index <5 and a C-reactive protein <5 mg/L, without prior need for ADA dose optimization and taking into account all kind of topical and systemic steroids
Time frame: Week 12
The predictive value of EFCA measured by IBDoc® between baseline and week 4, in predicting steroid-free clinical remission at week 12 , defined as an Harvey-Bradshaw-Index <5 and a C-reactive protein <5 mg/L, without prior need for ADA dose optimization and taking into account all kind of topical and systemic steroids. EFCA is defined as a decrease in faecal calprotectin measured by IBDoc® between baseline and week 4 with at least 80% or a faecal calprotectin less than 50 μg/g at week 4.
6 secondary outcomes
In UC: The predictive value of an absolute and relative faecal calprotectin measured by IBDoc® between baseline and week 4
Time frame: 4 weeks
In UC: The predictive value of an absolute and relative faecal calprotectin measured by IBDoc® between baseline and week 8
Time frame: 8 weeks
In CD: The predictive value of an absolute and relative faecal calprotectin measured by IBDoc® between baseline and week 4
Time frame: 4 weeks
In CD: The predictive value of an absolute and relative faecal calprotectin measured by IBDoc® between baseline and week 8
Time frame: 8 weeks
In UC and CD: correlations with IBDoc® measurements of faecal calprotectin and ELISA measurements of faecal calprotectin, different components of the Mayo score, C reactive protein and serum albumin
Time frame: 26 weeks
In UC and CD: The convenience of the IBDoc® system to the patient and the health care professional
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
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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.
Marc Ferrante, MD PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Based Fecal Calprotectin in people with Crohn Disease and Colitis, Ulcerative, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 11 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 27 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 1 site in Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
In UC: Steroid-free mucosal healing (Mayo 0 or 1) at week 8 without prior need for ADA dose optimization, taking into account all kind of topical and systemic steroids. (time frame: Week 8). 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 27 Jun 2024.