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.
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
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)
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- 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.
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- 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.
24 sites in 1 country
France24 sites, 18 recruiting
- Recruiting
CHU Amiens- Picardie (site Sud)
Amiens, 80054
Mathurin Fumery, fumery.mathurin@chu-amiens.fr
Mathurin Fumery
- Active, not recruiting
CHRU de Besançon - Hôpital Jean Minjoz
Besançon, 25030
- Withdrawn
CHU Caen Hôpital Côte de Nacre
Caen, 14033
- Active, not recruiting
Centre hospitalier de Cholet
Cholet, Maine Et Loire, 49300
- 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
- Active, not recruiting
CH Colmar - Hôpital Pasteur
Colmar, 68024
- Terminated
Centre hospitalier de Douai
Douai, 59507
- Recruiting
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
- Not yet recruiting
CH Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, 42270
Xavier Roblin, xavier.roblin@chu-st-etienne.fr
Xavier Roblin
- Withdrawn
CH Toulon - CHITS CH Sainte Musse
Toulon, 83056
- Recruiting
CHU Toulouse - Hôpital Rangueil
Toulouse, 31403
Cyrielle Gilletta, gilletta.c@chu-toulouse.fr
Cyrielle Gilletta
- Not yet recruiting
CH Tourcoing - Hôpital Gustave Dron
Tourcoing, 59200
Noemie Tavernier, ntavernier@ch-tourcoing.fr
Noemie Tavernier
- Recruiting
CHU Nancy - Hôpital de Brabois
Vandœuvre-lès-Nancy, 54500
Laurent Peyrin-Biroulet, peyrinbiroulet@gmail.com
Laurent Peyrin-Biroulet
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
- Conditions
- Ulcerative Colitis
- 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 group | Role | What they receive |
|---|---|---|
| Group Standard of care | Active comparator | In 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 education | Active comparator | Treatment 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.
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)
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
Efficacy of adalimumab treatment on endoscopic Healing (at Week 48)
Endoscopic healing rate with Mayo score 0 or 1
Measured: Week 48
Efficacy of adalimumab treatment on endoscopic mucosal healing
UCEIS score
Measured: Week 48
Efficacy of adalimumab treatment on histological Healing (at Week 48)
Histological healing (Nancy index)
Measured: Week 48
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
Patient satisfaction
Patient satisfaction evaluate with all questionnaires of quality of life
Measured: Week 48
Treatment compliance
Treatment compliance evaluate at every visit
Measured: Week 48
Patient adhesion
Patient adhesion evaluate with questionnaire
Measured: Week 48
Disability score evolution
IBD Disability index, evaluate visit 0 vs - Week 14, Week 26, Week 38 and Week 48
Measured: Week 48
Medico-economic analysis
Medico-economic comparative analysis between standard of care follow up and tight monitoring follow up
Measured: Week 48
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
Loss of clinical response
Pharmacokinetic dosage of Adalimumab (Anti-TNF)
Measured: Week 48
Number of visits in trial
Number of visits in trial per patients
Measured: Week 48
Colectomies at Week 48
Proportion of patients with colectomy
Measured: Week 48
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.
- First posted3 Dec 2019
- Study start14 Jan 2020
- Primary completionApr 2025 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor
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