A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab
CONTROL
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
1 other identifier
interventional
238
1 country
24
Brief 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®).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jan 2020
Longer than P75 for phase_4
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2019
CompletedFirst Posted
Study publicly available on registry
December 3, 2019
CompletedStudy Start
First participant enrolled
January 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
ExpectedMay 31, 2023
May 1, 2023
5.2 years
October 28, 2019
May 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
Week 48
Secondary Outcomes (15)
Efficacy of adalimumab treatment on clinical remission (at Week 48)
Week 48
Efficacy of adalimumab treatment on endoscopic Healing (at Week 48)
Week 48
Efficacy of adalimumab treatment on endoscopic mucosal healing
Week 48
Efficacy of adalimumab treatment on histological Healing (at Week 48)
Week 48
Efficacy of adalimumab treatment on patient quality of life (at Week 48)
Week 48
- +10 more secondary outcomes
Study Arms (2)
Group Standard of care
ACTIVE COMPARATORIn standard of care, patient only visits every 3 months the doctor so the optimization of treatment can be done only at this frequency.
Groupe T2T with telemonitoring and patient education
ACTIVE COMPARATORTreatment with e-Monitoring, home fecal calprotectin testing and therapy education.
Interventions
Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26)
Fecal calprotectin dosing at home with IBDoc
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
Patient Education at W0, W2, W14, W26 and W38.
Eligibility Criteria
You may qualify if:
- 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).
- A contraceptive method during the whole trial for childbearing potential female
- Patient familiar with Smartphone and internet use
You may not qualify if:
- 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.
- 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
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Centre hospitalier de Cholet
Cholet, Maine Et Loire, 49300, France
CHU Amiens- Picardie (site Sud)
Amiens, 80054, France
CHRU de Besançon - Hôpital Jean Minjoz
Besançon, 25030, France
CHU Caen Hôpital Côte de Nacre
Caen, 14033, France
CHU Estaing
Clermont-Ferrand, 63003, France
APHP - Hôpital Beaujon
Clichy, 92110, France
CH Colmar - Hôpital Pasteur
Colmar, 68024, France
Centre hospitalier de Douai
Douai, 59507, France
CHRU Lille Hôpital Claude Huriez
Lille, 59037, France
APHM - Hôpital Nord
Marseille, 13915, France
GHI Le Raincy-Montfermeil
Montfermeil, 93370, France
CHU Montpellier - Hôpital Saint Eloi
Montpellier, 34295, France
CHU Nantes - Hôpital Hotel Dieu
Nantes, 44093, France
CHU Nice- Hopital l'Archet
Nice, 62002, France
CHU Nîmes - Hôpital Universitaire Caremeau
Nîmes, 30029, France
CHU Bordeaux - Hôpital Haut Lévêque
Pessac, 33604, France
CHU Lyon Sud
Pierre-Bénite, 69495, France
CHU Rennes Hôpital Pontchaillou
Rennes, 35033, France
CH Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, 42270, France
CH Toulon - CHITS CH Sainte Musse
Toulon, 83056, France
CHU Toulouse - Hôpital Rangueil
Toulouse, 31403, France
CH Tourcoing - Hôpital Gustave Dron
Tourcoing, 59200, France
CHU Nancy - Hôpital de Brabois
Vandœuvre-lès-Nancy, 54500, France
APHP - Hôpital du Kremlin-Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, 94275, France
Related Publications (1)
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.
PMID: 40243391DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2019
First Posted
December 3, 2019
Study Start
January 14, 2020
Primary Completion
April 1, 2025
Study Completion (Estimated)
May 1, 2028
Last Updated
May 31, 2023
Record last verified: 2023-05