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NCT06742385: SECURITY
Evaluation of a Remote Monitoring Application in the Follow-up of Patients With Active Inflammatory Bowel Diseases
NA trial testing MedicWise in Crohn Disease in 290 participants. Currently enrolling.
18 September 2027
Quick facts
| Lead sponsor | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 290 |
| Start date | 18 September 2025 |
| Primary completion | 18 September 2027 |
| Estimated completion | 18 September 2028 |
| Sites | 1 location across France |
Drugs / interventions tested
- MedicWise
Conditions studied
- Crohn Disease — all drugs for Crohn Disease →
- Ulcerative Colitis — all drugs for Ulcerative Colitis →
Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives — full company profile →
Who can join
Adults 18 to 80, any sex, with Crohn Disease or Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06742385
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Crohn Disease
Currently open trials in the same condition.
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- NCT07364734 — Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease · recruiting
- NCT07170462 — Cranberry and Gut Health in Crohn's Disease · EARLY_PHASE1 · recruiting
- NCT07196722 — A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease · Phase 2, PHASE3 · recruiting
Other Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives trials
Trials by the same sponsor.
- NCT06250361 — Identification of Factors ASsociaTed With a Delayed Diagnosis in Crohn's Disease · unknown
- NCT06089590 — Ibd CAncer and seRious Infections in France (I-CARE 2) · recruiting
- NCT05158517 — VeDOlizumab PERsistence in IBD Patients After Switching From Intravenous to Subcutaneous Administration : a Real-life Mu · active not recruiting
- NCT05072782 — Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalat · Phase 4 · unknown
- NCT04990258 — A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Inflix · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06742385 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Last refreshed: 24 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06742385.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing