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

Ulcerative Colitis Clinical Trial

— CONTROL  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04183608
• Other study ID #: GETAID-2018-01
• Status: Recruiting
• Phase: Phase 4
• Start date: January 14, 2020
• Est. completion date: May 2028

Study information

• Verified date: May 2023
• Source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Contact: Xavier Hebuterne, MD PhD
• Phone: 04 92 03 65 75
• Email: hebuterne.x[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®).

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 information / eligibility

• Status: Recruiting
• Enrollment: 238
• Est. completion date: May 2028
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

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

Diagnostic Test:
• Calprotectin
Fecal calprotectin dosing at home with IBDoc

Other:
• 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.

Locations

Country	Name	City	State
France	CHU Amiens- Picardie (site Sud)	Amiens
France	CHRU de Besançon - Hôpital Jean Minjoz	Besançon
France	CHU Caen Hôpital Côte de Nacre	Caen
France	Centre hospitalier de Cholet	Cholet	Maine Et Loire
France	CHU Estaing	Clermont-Ferrand
France	APHP - Hôpital Beaujon	Clichy
France	CH Colmar - Hôpital Pasteur	Colmar
France	Centre hospitalier de Douai	Douai
France	APHP - Hôpital du Kremlin-Bicêtre	Le Kremlin-Bicêtre	Île-de-France
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

Sponsors (2)

Lead Sponsor	Collaborator
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives	AbbVie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic Remission	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	Week 48
Secondary	Efficacy of adalimumab treatment on clinical remission (at Week 48)	Remission without steroids: Remission rate and remission rate without steroids at study visits and Week 48	Week 48
Secondary	Efficacy of adalimumab treatment on endoscopic Healing (at Week 48)	Endoscopic healing rate with Mayo score 0 or 1	Week 48
Secondary	Efficacy of adalimumab treatment on endoscopic mucosal healing	UCEIS score	Week 48
Secondary	Efficacy of adalimumab treatment on histological Healing (at Week 48)	Histological healing (Nancy index)	Week 48
Secondary	Efficacy of adalimumab treatment on patient quality of life (at Week 48)	Quality of life evolution (evaluate visit 0 vs -Week 14, Week 26, Week 38 and Week 48)	Week 48
Secondary	Patient satisfaction	Patient satisfaction evaluate with all questionnaires of quality of life	Week 48
Secondary	Treatment compliance	Treatment compliance evaluate at every visit	Week 48
Secondary	Patient adhesion	Patient adhesion evaluate with questionnaire	Week 48
Secondary	Disability score evolution	IBD Disability index, evaluate visit 0 vs - Week 14, Week 26, Week 38 and Week 48	Week 48
Secondary	Medico-economic analysis	Medico-economic comparative analysis between standard of care follow up and tight monitoring follow up	Week 48
Secondary	Continuous Clinical Response (CCR)	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.	Week 48
Secondary	Loss of clinical response	Pharmacokinetic dosage of Adalimumab (Anti-TNF)	Week 48
Secondary	Number of visits in trial	Number of visits in trial per patients	Week 48
Secondary	Colectomies at Week 48	Proportion of patients with colectomy	Week 48
Secondary	UC related Hospitalizations at Week 48	Proportion of UC related hospitalizations	Week 48