Informations générales (source: ClinicalTrials.gov)
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 (CONTROL)
Interventional
Phase 4
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives (Voir sur ClinicalTrials)
janvier 2020
mai 2028
29 juin 2024
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®).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Beaujon | Yoram Bouhnik | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Bicêtre | Franck CARBONNEL, MD | Contact (sur clinicalTrials) | |||
| GHI LE RAINCY MONTFERMEIL | Stéphane Nahon | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| APHM - Hôpital Nord - 13915 - Marseille - France | Mélanie Serrero | Contact (sur clinicalTrials) | |||
| CH Colmar - Hôpital Pasteur - 68024 - Colmar - France | Contact (sur clinicalTrials) | ||||
| CH Saint Etienne Hopital Nord - 42270 - Saint-Priest-en-Jarez - France | Xavier Roblin | Contact (sur clinicalTrials) | |||
| CH Toulon - CHITS CH Sainte Musse - 83056 - Toulon - France | Contact (sur clinicalTrials) | ||||
| CHRU Lille Hôpital Claude Huriez - 59037 - Lille - France | Maria Nachury | Contact (sur clinicalTrials) | |||
| CHU Amiens- Picardie (site Sud) - 80054 - Amiens - France | Mathurin Fumery | Contact (sur clinicalTrials) | |||
| CHU Bordeaux - Hôpital Haut Lévêque - 33604 - Pessac - France | David Laharie | Contact (sur clinicalTrials) | |||
| CHU Caen Hôpital Côte de Nacre - 14033 - Caen - France | Contact (sur clinicalTrials) | ||||
| CHU Estaing - 63003 - Clermont-Ferrand - France | Anthony Buisson | Contact (sur clinicalTrials) | |||
| CHU Lyon Sud - 69495 - Pierre-Bénite - France | Stéphane Nancey | Contact (sur clinicalTrials) | |||
| CHU Montpellier - Hôpital Saint Eloi - 34295 - Montpellier - France | Lucile Boivineau | Contact (sur clinicalTrials) | |||
| CHU Nancy - Hôpital de Brabois - 54500 - Vandœuvre-lès-Nancy - France | Laurent Peyrin-Biroulet | Contact (sur clinicalTrials) | |||
| CHU Nantes - Hôpital Hotel Dieu - 44093 - Nantes - France | Caroline Trang | Contact (sur clinicalTrials) | |||
| CHU Nice- Hopital l'Archet - 62002 - Nice - France | Xavier Hebuterne | Contact (sur clinicalTrials) | |||
| CHU Toulouse - Hôpital Rangueil - 31403 - Toulouse - France | Cyrielle Gilletta | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre hospitalier de Cholet - 49300 - Cholet - Maine Et Loire - France | Contact (sur clinicalTrials) | ||||
| Centre hospitalier de Douai - 59507 - Douai - France | Contact (sur clinicalTrials) | ||||
| CH Tourcoing - Hôpital Gustave Dron - 59200 - Tourcoing - France | Noemie Tavernier | Contact (sur clinicalTrials) | |||
| CHRU de Besançon - Hôpital Jean Minjoz - 25030 - Besançon - France | Contact (sur clinicalTrials) | ||||
| CHU Nîmes - Hôpital Universitaire Caremeau - 30029 - Nîmes - France | Ludovic Caillo | Contact (sur clinicalTrials) | |||
| CHU Rennes Hôpital Pontchaillou - 35033 - Rennes - France | Guillaume Bouguen | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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