A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab
NCT ID: NCT04183608
Last Updated: 2023-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
238 participants
INTERVENTIONAL
2020-01-14
2028-05-31
Brief Summary
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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®).
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Group Standard of care
In standard of care, patient only visits every 3 months the doctor so the optimization of treatment can be done only at this frequency.
Adalimumab
Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26)
Groupe T2T with telemonitoring and patient education
Treatment with e-Monitoring, home fecal calprotectin testing and therapy 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
OTHER
Responsible Party
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Locations
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Centre hospitalier de Cholet
Cholet, Maine Et Loire, France
CHU Amiens- Picardie (site Sud)
Amiens, , France
CHRU de Besançon - Hôpital Jean Minjoz
Besançon, , 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
CHRU Lille Hôpital Claude Huriez
Lille, , France
APHM - Hôpital Nord
Marseille, , France
GHI Le Raincy-Montfermeil
Montfermeil, , France
CHU Montpellier - Hôpital Saint Eloi
Montpellier, , 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
CHU Lyon Sud
Pierre-Bénite, , France
CHU Rennes Hôpital Pontchaillou
Rennes, , France
CH Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, , France
CH Toulon - CHITS CH Sainte Musse
Toulon, , France
CHU Toulouse - Hôpital Rangueil
Toulouse, , France
CH Tourcoing - Hôpital Gustave Dron
Tourcoing, , France
CHU Nancy - Hôpital de Brabois
Vandœuvre-lès-Nancy, , France
APHP - Hôpital du Kremlin-Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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References
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Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
Other Identifiers
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GETAID-2018-01
Identifier Type: -
Identifier Source: org_study_id
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