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Clinical Trials in France / NCT04183608
Recruiting Phase 4

A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab

NCT04183608 · tracked via the Priya Life Science France tracker
Phase
Phase 4
Started
2020-01-14
Last updated
2023-05-31

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

Adalimumab →Calprotectine-MonitoringTherapy Education

Adalimumab: Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26)

Calprotectin: Fecal calprotectin dosing at home with IBDoc

e-Monitoring: e-Monitoring at Week 6, Week 10, Week 14, Week 18, Week 22, Week 26, Week 34, Week 38, Week 42 and Week 48 The patient must complete the first 2 questions of the Mayo score: * Stool frequency * The frequency of bleeding He must also complete the information on his injections

Therapy Education: Patient Education at W0, W2, W14, W26 and W38.

Study summary

PHASE: IV

DESCRIPTIVE: Randomized, interventional, open label multicenter trial

POPULATION: Moderate to severe ulcerative colitis

STUDY TREATMENTS: Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26) and could be optimized up to 80mg EOW (or 40 EW according to patient and/or investigator preference) for two months and then could be optimized up to 80mg EOW (or 40 EW according to patient and/or investigator preference) and azathioprine (2.0/2.5 mg/kg/ day) or methotrexate (25 mg EW) until V3 (W 38).

OBJECTIVES: To assess the impact of a treat to target treatment follow up by e-Monitoring and fecal calprotectin dosing at home associated to an appropriate patient education versus standard treatment follow up at W48 in patients requiring a treatment with adalimumab (Humira®).

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Adults with moderately-to-severely active Ulcerative Colitis (UC) who had an inadequate response to or failed to tolerate steroids and thiopurines (azathioprine or 6-mercaptopurine), methotrexate or vedolizumab or adults with moderately-to-severely active UC who had no response to an adequate steroid course * Age ≥ 18 years and \< 75 years * Patients scheduled to start a treatment with adalimumab * Naïve to anti-TNF therapy and other biologics known to be effective for UC (approved or investigational) except for vedolizumab * Naïve to JAK inhibitors (approved or investigational) * Moderately-to-severely active UC for at least 3 months with a Mayo score of 6-12 points (endoscopy subscore of at least 2) * Established diagnosis of UC for at least 3 months (pancolitis, left-sided colitis, proctosigmoiditis and proctitis are allowed). * Patient has to be treated with oral 5-ASA at time of inclusion regardless of the dose if no contra-indication. * Azathioprine, 6-mercaptopurine or methotrexate will be stopped two weeks before inclusion. * A contraceptive method during the whole trial for childbearing potential female * Patient familiar with Smartphone and internet use Exclusion Criteria: * Patients unable to give their consent (because of their physical or mental state). * Absence of written consent. * Pregnancy or breastfeeding. * Patients with severe acute colitis or patients at imminent risk for colectomy. * History of colectomy. * History of colonic mucosal dysplasia or adenomatous colonic polyps that are not removed. * Screening stool trial positive for enteric pathogens or Clostridium difficile toxin. * Oral corticosteroids at a dose \> 40 mg prednisone or its equivalent per day at inclusion (oral steroids should be at stable dose at least 7 days before inclusion) * Any current or previous use of cyclosporine, tacrolimus, anti-TNF therapy, and other biologics (except vedolizumab), JAK inhibitors (approved or investigational), or any current or previous use of an investigational agent within 5 half-lives of that agent before the first trial agent injection. * Contraindication to anti-TNF therapy according to drug labeling: * Active infection. * Non-treated latent tuberculosis. * Heart failure (NYHA: Grade III and IV). * Malignancy during the previous 5 years. * Demyelinating neurological disease. * Current or recent (less than 4 weeks) vaccination with attenuated live vaccines * Patients with a dominant arm deficiency or physical impairment impeding the achievement of the tests * Patients using a prohibited medication * Patients participating in another trial or being in a follow-up period for another trial

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
Centre hospitalier de Cholet Cholet Maine Et Loire Active Not Recruiting
CHU Amiens- Picardie (site Sud) Amiens France Recruiting
CHRU de Besançon - Hôpital Jean Minjoz Besançon France Active Not Recruiting
CHU Caen Hôpital Côte de Nacre Caen France Withdrawn
CHU Estaing Clermont-Ferrand France Recruiting
APHP - Hôpital Beaujon Clichy France Recruiting
CH Colmar - Hôpital Pasteur Colmar France Active Not Recruiting
Centre hospitalier de Douai Douai France Terminated
CHRU Lille Hôpital Claude Huriez Lille France Recruiting
APHM - Hôpital Nord Marseille France Recruiting
GHI Le Raincy-Montfermeil Montfermeil France Recruiting
CHU Montpellier - Hôpital Saint Eloi Montpellier France Recruiting
CHU Nantes - Hôpital Hotel Dieu Nantes France Recruiting
CHU Nice- Hopital l'Archet Nice France Recruiting
CHU Nîmes - Hôpital Universitaire Caremeau Nîmes France Recruiting
CHU Bordeaux - Hôpital Haut Lévêque Pessac France Recruiting
CHU Lyon Sud Pierre-Bénite France Recruiting
CHU Rennes Hôpital Pontchaillou Rennes France Recruiting
CH Saint Etienne Hopital Nord Saint-Priest-en-Jarez France Not Yet Recruiting
CH Toulon - CHITS CH Sainte Musse Toulon France Withdrawn
CHU Toulouse - Hôpital Rangueil Toulouse France Recruiting
CH Tourcoing - Hôpital Gustave Dron Tourcoing France Not Yet Recruiting
CHU Nancy - Hôpital de Brabois Vandœuvre-lès-Nancy France Recruiting
APHP - Hôpital du Kremlin-Bicêtre Le Kremlin-Bicêtre Île-de-France Region Recruiting

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04183608 on ClinicalTrials.gov ↗ ← All trials in France