A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab
- Conditions
- Ulcerative Colitis
- Interventions
- Registration Number
- NCT04183608
- Lead Sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Brief 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®).
- Detailed Description
NUMBER OF PATIENTS : 238 patients in 20 sites in France
RECRUITMENT PERIOD : The trial duration for each patient will be 144 weeks
MAIN ENDPOINT : At week 48 success defined by: Endoscopic remission defined by an endoscopic Mayo score 0
SECONDARY ENDPOINTS:
At W48
* Clinical remission (Clinical remission is defined as a total Mayo score ≤2 points, with no individual sub score \>1, and a Mayo endoscopy sub score of 0 or 1)
* Remission without steroids
* Endoscopic healing rate with Mayo score 0 or 1
* UCEIS score
* Histological healing (Nancy score)
* Remission rate and remission rate without steroids at study visits and W48
* Quality of life evolution (evaluate visit W0 vs W14, W26, W38 and W48)
* Patients satisfaction
* Continuous response
* Safety and tolerability
* Anti-TNF pharmacokinetics
* Number of visits in trial
* Number of UC related hospitalizations
* Number of colectomies
* Treatment compliance (questionnaire)
* Patient adhesion (questionnaire)
* Medico-economic analysis
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 238
- 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
-
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)
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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.
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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
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Patients using a prohibited medication
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Patients participating in another trial or being in a follow-up period for another trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Groupe T2T with telemonitoring and patient education e-Monitoring Treatment with e-Monitoring, home fecal calprotectin testing and therapy education. Groupe T2T with telemonitoring and patient education Calprotectin Treatment with e-Monitoring, home fecal calprotectin testing and therapy education. Groupe T2T with telemonitoring and patient education Therapy Education Treatment with e-Monitoring, home fecal calprotectin testing and therapy education. Group Standard of care Adalimumab In standard of care, patient only visits every 3 months the doctor so the optimization of treatment can be done only at this frequency. Groupe T2T with telemonitoring and patient education Adalimumab Treatment with e-Monitoring, home fecal calprotectin testing and therapy education.
- Primary Outcome Measures
Name Time Method Endoscopic Remission Week 48 Treatment success of a treat to target with telemonitoring follow up using e-Monitoring and fecal calprotectin dosing at home associated to an appropriate patient education compared to standard treatment follow up at Week 48.
Definition of treatment success: Endoscopic remission defined by an endoscopic Mayo score 0
- Secondary Outcome Measures
Name Time Method Efficacy of adalimumab treatment on endoscopic Healing (at Week 48) Week 48 Endoscopic healing rate with Mayo score 0 or 1
Efficacy of adalimumab treatment on histological Healing (at Week 48) Week 48 Histological healing (Nancy index)
Efficacy of adalimumab treatment on patient quality of life (at Week 48) Week 48 Quality of life evolution (evaluate visit 0 vs -Week 14, Week 26, Week 38 and Week 48)
Patient satisfaction Week 48 Patient satisfaction evaluate with all questionnaires of quality of life
Treatment compliance Week 48 Treatment compliance evaluate at every visit
Patient adhesion Week 48 Patient adhesion evaluate with questionnaire
Disability score evolution Week 48 IBD Disability index, evaluate visit 0 vs - Week 14, Week 26, Week 38 and Week 48
Number of visits in trial Week 48 Number of visits in trial per patients
Colectomies at Week 48 Week 48 Proportion of patients with colectomy
UC related Hospitalizations at Week 48 Week 48 Proportion of UC related hospitalizations
Efficacy of adalimumab treatment on clinical remission (at Week 48) Week 48 * Remission without steroids:
* Remission rate and remission rate without steroids at study visits and Week 48Efficacy of adalimumab treatment on endoscopic mucosal healing Week 48 UCEIS score
Continuous Clinical Response (CCR) Week 48 Definition: Partial Mayo Response at each visit (Visit 1, Visit 2, Visit 3) with a total Mayo response on Week 48 Visit 4 visit. In the telemonitoring group the partial Mayo limited to questions 1 and 2 will be directly answered by patients themselves through ePRO2 they will score the first 2 questions of partial Mayo from home and send that info to the investigator.
Loss of clinical response Week 48 Pharmacokinetic dosage of Adalimumab (Anti-TNF)
Medico-economic analysis Week 48 Medico-economic comparative analysis between standard of care follow up and tight monitoring follow up
Trial Locations
- Locations (24)
CHRU de Besançon - Hôpital Jean Minjoz
🇫🇷Besançon, France
Centre hospitalier de Cholet
🇫🇷Cholet, Maine Et Loire, France
APHP - Hôpital du Kremlin-Bicêtre
🇫🇷Le Kremlin-Bicêtre, Île-de-France, France
CHU Amiens- Picardie (site Sud)
🇫🇷Amiens, France
CHU Caen Hôpital Côte de Nacre
🇫🇷Caen, France
CHU Estaing
🇫🇷Clermont-Ferrand, France
APHP - Hôpital Beaujon
🇫🇷Clichy, France
CH Colmar - Hôpital Pasteur
🇫🇷Colmar, France
Centre hospitalier de Douai
🇫🇷Douai, France
GHI Le Raincy-Montfermeil
🇫🇷Montfermeil, France
CHU Montpellier - Hôpital Saint Eloi
🇫🇷Montpellier, France
CHRU Lille Hôpital Claude Huriez
🇫🇷Lille, France
APHM - Hôpital Nord
🇫🇷Marseille, France
CHU Nantes - Hôpital Hotel Dieu
🇫🇷Nantes, France
CHU Nice- Hopital l'Archet
🇫🇷Nice, France
CHU Nîmes - Hôpital Universitaire Caremeau
🇫🇷Nîmes, France
CHU Bordeaux - Hôpital Haut Lévêque
🇫🇷Pessac, France
CH Saint Etienne Hopital Nord
🇫🇷Saint-Priest-en-Jarez, France
CHU Lyon Sud
🇫🇷Pierre-Bénite, France
CHU Rennes Hôpital Pontchaillou
🇫🇷Rennes, France
CHU Toulouse - Hôpital Rangueil
🇫🇷Toulouse, France
CH Toulon - CHITS CH Sainte Musse
🇫🇷Toulon, France
CH Tourcoing - Hôpital Gustave Dron
🇫🇷Tourcoing, France
CHU Nancy - Hôpital de Brabois
🇫🇷Vandœuvre-lès-Nancy, France