An interventional study of MedicWise in Crohn Disease and Ulcerative Colitis, sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. Active, not recruiting at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Not applicable, Interventional, and Other
Among 22 studies in Crohn Disease by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives — 5 open to participants now, 6 under way, none of them phase 3. Crohn Disease · Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives.
Among the 22 studies in Crohn Disease by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives, this one has the largest planned enrollment of the 16 interventional ones, is the only one that started in 2025, is one of 4 with no phase, and was the 19th registered.
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 290 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →5 of the 22 studies in Crohn Disease by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives are open now, in 1 country. Each count lists the studies.
Of the 354 Crohn Disease studies recruiting now, 155 (44%) set no upper age limit and 144 (41%) stop at 75 or younger; 96 take children under 18; 56 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →22 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2025.
Median enrollment 114 across the 16 interventional studies, 460 across the 6 observational. Of the 15 that completed or were terminated, 0 (0%) have results posted.
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives is the lead sponsor of 35 studies on the registry; 7 are open to participants now.
2 of the studies in Crohn Disease by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06742385Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesEvaluation of a Remote Monitoring Application in the Follow-up of Patients With Active Inflammatory Bowel Diseases | 2027-09-18 |
| NCT07292012Groupe d'Etude Therapeutique des Affections Inflammatoires DigestivesEfficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease | 2027-11 |
Among the 22 studies in Crohn Disease by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives, from their registry updates:
Telemonitoring is of definite theoretical interest for patients suffering from chronic diseases and could help to improve monitoring of treatment efficacy and tolerance, and hence remission and quality of life. Reimbursement is now planned in France for devices that have demonstrated a positive effect on patient intake. However, available studies testing different tools in IBD have shown no significant improvement in disease control or quality of life. Nevertheless, major secondary endpoints such as reduced hospitalization, complications and healthcare costs have been demonstrated. Several biases have been identified to explain these disappointing results, such as the heterogeneity of the tools/applications tested, methodological limitations concerning the main objective and technological limitations of the tools evaluated.
We propose here to evaluate the impact of a tight remote monitoring through digital tool on disease control, in patients with active IBD, thanks to the MedicWise platform. The technology of the MedicWise solution enables the automatic collection of a wide range of biological and healthcare consumption data, thus limiting the need for patient input. MedicWise has obtained the CE label and is already used and reimbursed in France in other chronic diseases. The SECURITY trial proposes to evaluate the impact of a tight remote monitoring through digital tool on time spent in remission. Improvement of IBD related disability is also a major secondary objective of the study. It also has the following secondary objectives to analyze the impact of this tool on the organization of care teams caring for patients with IBD.
Telemonitoring is of definite theoretical interest for patients suffering from chronic diseases and could help to improve monitoring of treatment efficacy and tolerance, and hence remission and quality of life. Reimbursement is now planned in France for devices that have demonstrated a positive effect on patient intake. However, available studies testing different tools in IBD have shown no significant improvement in disease control or quality of life. Nevertheless, major secondary endpoints such as reduced hospitalization, complications and healthcare costs have been demonstrated. Several biases have been identified to explain these disappointing results, such as the heterogeneity of the tools/applications tested, methodological limitations concerning the main objective and technological limitations of the tools evaluated.
We propose here to evaluate the impact of a tight remote monitoring through digital tool on disease control, in patients with active IBD, thanks to the MedicWise platform. The technology of the MedicWise solution enables the automatic collection of a wide range of biological and healthcare consumption data, thus limiting the need for patient input. MedicWise has obtained the CE label and is already used and reimbursed in France in other chronic diseases. The SECURITY trial proposes to evaluate the impact of a tight remote monitoring through digital tool on time spent in remission. Improvement of IBD related disability is also a major secondary objective of the study. It also has the following secondary objectives to analyze the impact of this tool on the organization of care teams caring for patients with IBD.
Main objective: To evaluate whether tight control through remote monitoring device improves disease activity compare to standard of care in patients with active Inflammatory Bowel Disease (IBD).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Both arms are equipped with the application, data are collected via the application and telemonitoring with alerts to the care team are activated in the active telemonitoring arm.
Device: MedicWise
Both arms are equipped with the application, data are collected via the application and telemonitoring with alerts to the care team are inactivated in the active control arm.
* Both arms are equipped with the application, data are collected via the application and telemonitoring with alerts to the care team are activated in the active telemonitoring arm. * Data are collected in both arms at baseline, M3, M6, M9 and M12 * Each center defines who handles alerts internally (physicians, IBD nurses, others, etc.) according to its internal organization. The application does not impose an internal operation. * the alert thresholds are identical and fixed for all centers during the study. Within the framework of the study, alerts are defined according to the study's modalities but cannot be modified by the centers. * Participating sites will have no obligation to respond to alerts. * Randomization will be stratified by centers and by diseases (Crohn and UC) with unbalanced blocks of randomization
Percentage of cumulative time spent in symptomatic remission within 12 months
Percentage of cumulative time spent in symptomatic remission within 12 months Time spent in symptomatic remission defined by (PRO2): MC: abdominal pain ≤ 1 and stool frequency ≤ 3 defined clinical remission in CD, both not worsening compared from inclusion UC: absence of rectal bleeding (score 0) and stool frequency score ≤ 1, both not worsening compared with inclusion
Time frame: 12 months
Average value of IBD disk change from baseline over 12 months (M3, M6, M9 and M12)
Average value of IBD disk change from baseline over 12 months (M3, M6, M9 and M12)
Time frame: 12 months
Average value of IBD disk change from baseline over 12 months
Average value of IBD disk change from baseline over 12 months
Time frame: 12 months
Patient report outcomes (PR02), questionnaire to assess this outcome measure at M6 and M12
Patient report outcomes (PR02), questionnaire to assess this outcome measure at M6 and M12
Time frame: 6 and 12 months
Short Inflammatory Bowel Disease (S-IBDQ) delta mean value between inclusion and M12 (The total score ranges from 10 to 70, with the higher the score, the better the quality of life.)
Short Inflammatory Bowel Disease (S-IBDQ) delta mean value between inclusion and M12
Time frame: 12 months
Average value of Short Inflammatory Bowel Disease (S-IBDQ) delta mean value between inclusion and M12 (The total score ranges from 10 to 70, with the higher the score, the better the quality of life.) change from baseline over 12 months
Average value of Short Inflammatory Bowel Disease (S-IBDQ) delta mean value between inclusion and M12 (The total score ranges from 10 to 70, with the higher the score, the better the quality of life.) change from baseline over 12 months
Time frame: 12 months
Number of contacts / consultations / hospitalizations during 12 months
Number of contacts / consultations / hospitalizations during 12 months
Time frame: 12 months
Medication and care compliance/consumption over 12 months
Medication and care compliance/consumption over 12 months
Time frame: 12 months
number of complications (AE/SAE, hospitalizations, surgeries) over 12 months
number of complications (AE/SAE, hospitalizations, surgeries) over 12 months
Time frame: 12 months
Satisfaction questionnaires (patients/care team) at M12
Satisfaction questionnaires (patients/care team) at M12
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives