Clinical trial NCT04183608: A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab
Official title: An Open-label Randomized Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating adaLimumab: The CONTROL Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Ulcerative Colitis
Keywords: IBD
UC
Lead sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2019-12-03
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: 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 outcomes:
measure: Endoscopic Remission
timeFrame: Week 48
Secondary outcomes:
measure: Efficacy of adalimumab treatment on clinical remission (at Week 48)
timeFrame: Week 48
measure: Efficacy of adalimumab treatment on endoscopic Healing (at Week 48)
timeFrame: Week 48
measure: Efficacy of adalimumab treatment on endoscopic mucosal healing
timeFrame: Week 48
measure: Efficacy of adalimumab treatment on histological Healing (at Week 48)
timeFrame: Week 48
measure: Efficacy of adalimumab treatment on patient quality of life (at Week 48)
timeFrame: Week 48
measure: Patient satisfaction
timeFrame: Week 48
measure: Treatment compliance
timeFrame: Week 48
measure: Patient adhesion
timeFrame: Week 48
measure: Disability score evolution
timeFrame: Week 48
measure: Medico-economic analysis
timeFrame: Week 48
measure: Continuous Clinical Response (CCR)
timeFrame: Week 48
measure: Loss of clinical response
timeFrame: Week 48
measure: Number of visits in trial
timeFrame: Week 48
measure: Colectomies at Week 48
timeFrame: Week 48
measure: UC related Hospitalizations at Week 48
timeFrame: Week 48
Other outcomes:
Locations:
city: Cholet
country: France
facility: Centre hospitalier de Cholet
state: Maine Et Loire
city: Amiens
country: France
facility: CHU Amiens- Picardie (site Sud)
city: Besançon
country: France
facility: CHRU de Besançon - Hôpital Jean Minjoz
city: Caen
country: France
facility: CHU Caen Hôpital Côte de Nacre
city: Clermont-Ferrand
country: France
facility: CHU Estaing
city: Clichy
country: France
facility: APHP - Hôpital Beaujon
city: Colmar
country: France
facility: CH Colmar - Hôpital Pasteur
city: Douai
country: France
facility: Centre hospitalier de Douai
city: Lille
country: France
facility: CHRU Lille Hôpital Claude Huriez
city: Marseille
country: France
facility: APHM - Hôpital Nord
city: Montfermeil
country: France
facility: GHI Le Raincy-Montfermeil
city: Montpellier
country: France
facility: CHU Montpellier - Hôpital Saint Eloi
city: Nantes
country: France
facility: CHU Nantes - Hôpital Hotel Dieu
city: Nice
country: France
facility: CHU Nice- Hopital l'Archet
city: Nîmes
country: France
facility: CHU Nîmes - Hôpital Universitaire Caremeau
city: Pessac
country: France
facility: CHU Bordeaux - Hôpital Haut Lévêque
city: Pierre-Bénite
country: France
facility: CHU Lyon Sud
city: Rennes
country: France
facility: CHU Rennes Hôpital Pontchaillou
city: Saint-Priest-en-Jarez
country: France
facility: CH Saint Etienne Hopital Nord
city: Toulon
country: France
facility: CH Toulon - CHITS CH Sainte Musse
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Rangueil
city: Tourcoing
country: France
facility: CH Tourcoing - Hôpital Gustave Dron
city: Vandœuvre-lès-Nancy
country: France
facility: CHU Nancy - Hôpital de Brabois
city: Le Kremlin-Bicêtre
country: France
facility: APHP - Hôpital du Kremlin-Bicêtre
state: Île-de-France
Study officials:
References: