Crohn DiseasePhase 4NCT04775732
Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease
A Phase 4 study testing infliximab therapeutic drug monitoring in people with Crohn Disease and Ulcerative Colitis, run by Imelda GI Clinical Research Center at 2 sites in Belgium.
Trial summary
This is a comparative pragmatic trial in patients with UC and CD on maintenance treatment with IFX. All IBD patients from cohort A with maintenance IFX treatment at a referral IBD clinic are prospectively included between June and August 2018. An ultra-proactive IFX TDM algorithm is applied as follows. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis
- What is being tested?
- infliximab therapeutic drug monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Jun 2018to 30 Sep 2019
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all adult IBD patients treated for at least 14 weeks with infliximab were included
Who cannot join
- induction treatment with infliximab (<14 weeks)
- treatment with other biological for IBD
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Imelda GI clinical research center
Bonheiden, 2820
AZ Sint Lucas
Ghent, 9000
About this study
Official title: Ultra-proactive Therapeutic Drug Monitoring of Infliximab Based on Point-of-care-testing in Inflammatory Bowel Disease: a Pragmatic Trial
This is a comparative pragmatic trial in patients with UC and CD on maintenance treatment with IFX. All IBD patients from cohort A with maintenance IFX treatment at a referral IBD clinic are prospectively included between June and August 2018. An ultra-proactive IFX TDM algorithm is applied as follows. All patients have an ELISA TL measurement at baseline, of which the result determined the follow-up pathway: (A) TL between 3-7μg/mL: continuation at same dose and interval; (B) TL >7μg/mL: interval prolongation allowed; (C) TL <3μg/mL: interval shortening with minimum 2 weeks, with the next IFX TL measured using a POCT. (i) If the POCT showed an IFX TL <3μg/mL, dose was optimized ad hoc using a linear dosing formula (Dosen = (TL target * Dose n-1) / TL measured), followed by a new POCT test at next visit with the same interval. (ii) If the POCT showed an IFX TL ≥3µg/mL, no additional dose was given and routine TL testing with ELISA was retaken at next visit. At every visit this algorithm was reapplied to all patients.
The patients from cohort A will be compared with the patients from cohort B. The patients in cohort B receive maintenance IFX treatment at a referral IBD clinic during the same period. Dose adjustment are done based on standard of care reactive TDM of IFX and clinical symptoms. Data will be collected retrospectively to avoid treatment optimization bias.
- Conditions
- Crohn Disease, Ulcerative Colitis
- Being tested
- infliximab therapeutic drug monitoring
- Keywords
- therapeutic drug monitoring, inflammatory bowel disease, point of care testing, infliximab
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infliximab therapeutic drug monitoringBiological
dose optimization of infliximab based on a predefined dosing algorithm
| Study group | Role | What they receive |
|---|---|---|
| ultra proactive arm | Experimental | Not described Receives: Biological: infliximab therapeutic drug monitoring |
| reactive arm | Active comparator | Not described Receives: Biological: infliximab therapeutic drug monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with infliximab failure
number of patients with infliximab failure after one year (infliximab failure = infliximab discontinuation, IBD related surgery, IBD related hospitalization, add-on IBD treatment, and allergic reaction to infliximab)
Measured: one year
Secondary outcomes (5)
number of TL measurements per patient per year
Measured: one year
percentage of interval changes (shortening, prolongation, bidirectional)
Measured: one year
number of patients with infliximab discontinuation
number of patients with discontinuation of infliximab
Measured: one year
percentage of patients with sustained clinical remission
number of patients with physician global assessment <1 and all visits
Measured: one year
number of patients with mucosal remission
number of patients with mucosal remission after one year. (Mucosal remission = simple endoscopic score for CD <3, Rutgeertscore <i2 for, Mayo endoscopic subscore <1 and faecal calprotectin <250 µg/ml. Endoscopy and/or faecal calprotectin between 6 and 12 months after inclusion. If endoscopy and faecal calprotectin at the same moment, then endoscopy was dominant)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start1 Jun 2018
- Primary completion31 Aug 2019
- Study completion30 Sep 2019
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pragmatic cluster trial
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imelda GI Clinical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Bossuyt, Imelda GI Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775732
- Sponsor's protocol ID
- 200840
- Status last verified
- Jul 2021
- First submitted
- 25 Feb 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-proactive Therapeutic Drug Monitoring of Infliximab Based on Point-of-care-testing in Inflammatory Bowel Disease: a Pragmatic Trial
- ClinicalTrials.gov ID
- NCT04775732
- Acronym / sponsor ID
- 200840
- Conditions
- Crohn Disease, Ulcerative Colitis
- Keywords
- therapeutic drug monitoring, inflammatory bowel disease, point of care testing, infliximab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Imelda GI Clinical Research CenterUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 1 Mar 2021 (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.
This is a comparative pragmatic trial in patients with UC and CD on maintenance treatment with IFX. All IBD patients from cohort A with maintenance IFX treatment at a referral IBD clinic are prospectively included between June and August 2018. An ultra-proactive IFX TDM algorithm is applied as follows. All patients have an ELISA TL measurement at baseline, of which the result determined the follow-up pathway: (A) TL between 3-7μg/mL: continuation at same dose and interval; (B) TL >7μg/mL: interval prolongation allowed; (C) TL <3μg/mL: interval shortening with minimum 2 weeks, with the next IFX TL measured using a POCT. (i) If the POCT showed an IFX TL <3μg/mL, dose was optimized ad hoc using a linear dosing formula (Dosen = (TL target * Dose n-1) / TL measured), followed by a new POCT test at next visit with the same interval. (ii) If the POCT showed an IFX TL ≥3µg/mL, no additional dose was given and routine TL testing with ELISA was retaken at next visit. At every visit this algorithm was reapplied to all patients.
The patients from cohort A will be compared with the patients from cohort B. The patients in cohort B receive maintenance IFX treatment at a referral IBD clinic during the same period. Dose adjustment are done based on standard of care reactive TDM of IFX and clinical symptoms. Data will be collected retrospectively to avoid treatment optimization bias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pragmatic cluster trial
| Arm | Type | Receives |
|---|---|---|
| ultra proactive arm | Experimental | Biological: infliximab therapeutic drug monitoring |
| reactive arm | Active comparator | Biological: infliximab therapeutic drug monitoring |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all adult IBD patients treated for at least 14 weeks with infliximab were included
Key exclusion criteria (2 listed)
- induction treatment with infliximab (<14 weeks)
- treatment with other biological for IBD
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 |
|---|---|---|
| infliximab therapeutic drug monitoringdose optimization of infliximab based on a predefined dosing algorithm | Biological | reactive arm, ultra proactive arm |
Primary outcome
number of patients with infliximab failure
Time frame: one year
number of patients with infliximab failure after one year (infliximab failure = infliximab discontinuation, IBD related surgery, IBD related hospitalization, add-on IBD treatment, and allergic reaction to infliximab)
5 secondary outcomes
number of TL measurements per patient per year
Time frame: one year
percentage of interval changes (shortening, prolongation, bidirectional)
Time frame: one year
number of patients with infliximab discontinuation
Time frame: one year
percentage of patients with sustained clinical remission
Time frame: one year
number of patients with mucosal remission
Time frame: one year
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 5 Aug 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Crohn Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing infliximab therapeutic drug monitoring in people with Crohn Disease and Ulcerative Colitis, run by Imelda GI Clinical Research Center at 2 sites 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 1 inclusion and 2 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 5 Aug 2021. 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
number of patients with infliximab failure (time frame: one year). 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 5 Aug 2021.