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Ulcerative ColitisPhase 4CONTROLNCT04183608

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

A Phase 4 study testing Adalimumab, Calprotectin and e-Monitoring in people with Ulcerative Colitis, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 24 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Adalimumab, Calprotectin and e-Monitoring
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
238 participants
Where
24 sitesFrance
Study dates
14 Jan 2020to May 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 11Show fewer
  • 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

Who cannot join

  • 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.
Show all 19Show fewer
  • 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

Trial locations and contacts

24 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xavier Hebuterne, MD PhD contact

04 92 03 65 75

hebuterne.x@chu-nice.fr

24 sites in 1 country

France24 sites, 18 recruiting

  • CHU Amiens- Picardie (site Sud)

    Amiens, 80054

    Mathurin Fumery, fumery.mathurin@chu-amiens.fr

    Mathurin Fumery

    Recruiting

  • CHRU de Besançon - Hôpital Jean Minjoz

    Besançon, 25030

    Active, not recruiting

  • CHU Caen Hôpital Côte de Nacre

    Caen, 14033

    Withdrawn

  • Centre hospitalier de Cholet

    Cholet, Maine Et Loire, 49300

    Active, not recruiting

  • CHU Estaing

    Clermont-Ferrand, 63003

    Anthony Buisson, a_buisson@hotmail.fr

    Anthony Buisson

    Recruiting

  • APHP - Hôpital Beaujon

    Clichy, 92110

    Yoram Bouhnik, yoram.bouhnik@aphp.fr

    Yoram Bouhnik

    Recruiting

  • CH Colmar - Hôpital Pasteur

    Colmar, 68024

    Active, not recruiting

  • Centre hospitalier de Douai

    Douai, 59507

    Terminated

  • APHP - Hôpital du Kremlin-Bicêtre

    Le Kremlin-Bicêtre, Île-de-France Region, 94275

    Franck CARBONNEL, MD, franck.carbonnel@bct.aphp.fr

    Franck CARBONNEL, MD

    Recruiting

  • CHRU Lille Hôpital Claude Huriez

    Lille, 59037

    Maria Nachury, maria.nachury@CHRU-lille.fr

    Maria Nachury

    Recruiting

  • APHM - Hôpital Nord

    Marseille, 13915

    Mélanie Serrero, MELANIE.SERRERO@ap-hm.fr

    Mélanie Serrero

    Recruiting

  • GHI Le Raincy-Montfermeil

    Montfermeil, 93370

    Stéphane Nahon, snahon@ch-montfermeil.fr

    Stéphane Nahon

    Recruiting

  • CHU Montpellier - Hôpital Saint Eloi

    Montpellier, 34295

    Lucile Boivineau, l-boivineau@chu-montpellier.fr

    Lucile Boivineau

    Recruiting

  • CHU Nantes - Hôpital Hotel Dieu

    Nantes, 44093

    Caroline Trang, caroline.trang@chu-nantes.fr

    Caroline Trang

    Recruiting

  • CHU Nice- Hopital l'Archet

    Nice, 62002

    Xavier Hebuterne, hebuterne.x@chu-nice.fr

    Xavier Hebuterne

    Recruiting

  • CHU Nîmes - Hôpital Universitaire Caremeau

    Nîmes, 30029

    Ludovic Caillo, ludovic.caillo@chu-nimes.fr

    Ludovic Caillo

    Recruiting

  • CHU Bordeaux - Hôpital Haut Lévêque

    Pessac, 33604

    David Laharie, david.laharie@chu-bordeaux.fr

    David Laharie

    Recruiting

  • CHU Lyon Sud

    Pierre-Bénite, 69495

    Stéphane Nancey, stephane.nancey@chu-lyon.fr

    Stéphane Nancey

    Recruiting

  • CHU Rennes Hôpital Pontchaillou

    Rennes, 35033

    Guillaume Bouguen, guillaume.bouguen@chu-rennes.fr

    Guillaume Bouguen

    Recruiting

  • CH Saint Etienne Hopital Nord

    Saint-Priest-en-Jarez, 42270

    Xavier Roblin, xavier.roblin@chu-st-etienne.fr

    Xavier Roblin

    Not yet recruiting

  • CH Toulon - CHITS CH Sainte Musse

    Toulon, 83056

    Withdrawn

  • CHU Toulouse - Hôpital Rangueil

    Toulouse, 31403

    Cyrielle Gilletta, gilletta.c@chu-toulouse.fr

    Cyrielle Gilletta

    Recruiting

  • CH Tourcoing - Hôpital Gustave Dron

    Tourcoing, 59200

    Noemie Tavernier, ntavernier@ch-tourcoing.fr

    Noemie Tavernier

    Not yet recruiting

  • CHU Nancy - Hôpital de Brabois

    Vandœuvre-lès-Nancy, 54500

    Laurent Peyrin-Biroulet, peyrinbiroulet@gmail.com

    Laurent Peyrin-Biroulet

    Recruiting

Other trials in France

About this study

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

PHASE: IV

DESCRIPTIVE: Randomized, interventional, open label multicenter trial

Read more

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®).

Read the 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
Being tested
Adalimumab, Calprotectin, e-Monitoring, Therapy Education
Keywords
IBD, UC
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AdalimumabDrug

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

  • CalprotectinDiagnostic test

    Fecal calprotectin dosing at home with IBDoc

  • e-MonitoringOther

    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 EducationOther

    Patient Education at W0, W2, W14, W26 and W38.

Study groups in NCT04183608
Study groupRoleWhat they receive
Group Standard of careActive comparatorIn standard of care, patient only visits every 3 months the doctor so the optimization of treatment can be done only at this frequency.
Receives: Drug: Adalimumab
Groupe T2T with telemonitoring and patient educationActive comparatorTreatment with e-Monitoring, home fecal calprotectin testing and therapy education.
Receives: Drug: Adalimumab; Diagnostic Test: Calprotectin; Other: e-Monitoring; Other: Therapy Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 48

Secondary outcomes (15)

  1. 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

    Measured: Week 48

  2. Efficacy of adalimumab treatment on endoscopic Healing (at Week 48)

    Endoscopic healing rate with Mayo score 0 or 1

    Measured: Week 48

  3. Efficacy of adalimumab treatment on endoscopic mucosal healing

    UCEIS score

    Measured: Week 48

  4. Efficacy of adalimumab treatment on histological Healing (at Week 48)

    Histological healing (Nancy index)

    Measured: Week 48

  5. 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)

    Measured: Week 48

  6. Patient satisfaction

    Patient satisfaction evaluate with all questionnaires of quality of life

    Measured: Week 48

  7. Treatment compliance

    Treatment compliance evaluate at every visit

    Measured: Week 48

  8. Patient adhesion

    Patient adhesion evaluate with questionnaire

    Measured: Week 48

  9. Disability score evolution

    IBD Disability index, evaluate visit 0 vs - Week 14, Week 26, Week 38 and Week 48

    Measured: Week 48

  10. Medico-economic analysis

    Medico-economic comparative analysis between standard of care follow up and tight monitoring follow up

    Measured: Week 48

  11. 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.

    Measured: Week 48

  12. Loss of clinical response

    Pharmacokinetic dosage of Adalimumab (Anti-TNF)

    Measured: Week 48

  13. Number of visits in trial

    Number of visits in trial per patients

    Measured: Week 48

  14. Colectomies at Week 48

    Proportion of patients with colectomy

    Measured: Week 48

  15. UC related Hospitalizations at Week 48

    Proportion of UC related hospitalizations

    Measured: Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2019
  2. Study start14 Jan 2020
  3. Primary completionApr 2025 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
238 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04183608
Sponsor's protocol ID
GETAID-2018-01
Acronym
CONTROL
Status last verified
May 2023
First submitted
28 Oct 2019
Last updated
31 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40243391

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adalimumab, Calprotectin and e-Monitoring in people with Ulcerative Colitis, run by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives at 24 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xavier Hebuterne, MD PhD (04 92 03 65 75, hebuterne.x@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Endoscopic Remission (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04183608, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.

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