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

May 30, 2023 updated by: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

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

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®).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

238

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France, 80054
        • Recruiting
        • CHU Amiens- Picardie (site Sud)
        • Contact:
        • Principal Investigator:
          • Mathurin FUMERY
      • Besançon, France, 25030
        • Active, not recruiting
        • CHRU de Besancon - Hopital Jean Minjoz
      • Caen, France, 14033
        • Withdrawn
        • CHU CAEN Hopital Cote de Nacre
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU Estaing
        • Principal Investigator:
          • Anthony Buisson
        • Contact:
      • Clichy, France, 92110
        • Recruiting
        • APHP - Hôpital Beaujon
        • Contact:
        • Principal Investigator:
          • Yoram Bouhnik
      • Colmar, France, 68024
        • Active, not recruiting
        • CH Colmar - Hopital Pasteur
      • Douai, France, 59507
        • Terminated
        • Centre Hospitalier de Douai
      • Lille, France, 59037
        • Recruiting
        • CHRU Lille Hôpital Claude Huriez
        • Contact:
        • Principal Investigator:
          • Maria NACHURY
      • Marseille, France, 13915
        • Recruiting
        • APHM - Hôpital Nord
        • Contact:
        • Principal Investigator:
          • Melanie Serrero
      • Montfermeil, France, 93370
        • Recruiting
        • GHI Le Raincy-Montfermeil
        • Contact:
        • Principal Investigator:
          • Stephane Nahon
      • Montpellier, France, 34295
        • Recruiting
        • CHU Montpellier - Hôpital Saint Eloi
        • Contact:
        • Principal Investigator:
          • Lucile Boivineau
      • Nantes, France, 44093
        • Recruiting
        • CHU NANTES - Hôpital Hôtel Dieu
        • Contact:
        • Principal Investigator:
          • Caroline Trang
      • Nice, France, 62002
        • Recruiting
        • CHU Nice- Hopital l'Archet
        • Contact:
        • Principal Investigator:
          • Xavier Hebuterne
      • Nîmes, France, 30029
        • Recruiting
        • CHU Nîmes - Hôpital universitaire Carémeau
        • Contact:
        • Principal Investigator:
          • Ludovic Caillo
      • Pessac, France, 33604
        • Recruiting
        • CHU Bordeaux - Hôpital Haut Lévêque
        • Principal Investigator:
          • David Laharie
        • Contact:
      • Pierre-Bénite, France, 69495
      • Rennes, France, 35033
      • Saint-Priest-en-Jarez, France, 42270
      • Toulon, France, 83056
        • Withdrawn
        • CH Toulon - CHITS CH Sainte Musse
      • Toulouse, France, 31403
        • Recruiting
        • CHU Toulouse - Hôpital Rangueil
        • Contact:
        • Principal Investigator:
          • cyrielle Gilletta
      • Tourcoing, France, 59200
        • Not yet recruiting
        • CH Tourcoing - Hôpital Gustave Dron
        • Contact:
        • Principal Investigator:
          • Noemie Tavernier
      • Vandœuvre-lès-Nancy, France, 54500
        • Recruiting
        • CHU Nancy - Hôpital de Brabois
        • Contact:
        • Principal Investigator:
          • Laurent Peyrin-Biroulet
    • Maine Et Loire
      • Cholet, Maine Et Loire, France, 49300
        • Active, not recruiting
        • Centre Hospitalier de Cholet
    • Île-de-France
      • Le Kremlin-Bicêtre, Île-de-France, France, 94275
        • Recruiting
        • APHP - Hôpital du Kremlin-Bicêtre
        • Contact:
        • Principal Investigator:
          • Franck CARBONNEL, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Adalimumab
Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26)
Active Comparator: Groupe T2T with telemonitoring and patient education
Treatment with e-Monitoring, home fecal calprotectin testing and therapy education.
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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic Remission
Time Frame: 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
Week 48

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Collaborators

AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2020

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

October 28, 2019

First Submitted That Met QC Criteria

November 28, 2019

First Posted (Actual)

December 3, 2019

Study Record Updates

Last Update Posted (Actual)

May 31, 2023

Last Update Submitted That Met QC Criteria

May 30, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GETAID-2018-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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