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

Study Purpose

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®).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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) or methotrexate 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 (i.
e anti-integrin antibodies) or other biologics known to be effective for UC (approved or investigational)
  • - Naïve to JAK inhibitors (approved or investigational) - Adults with 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:

  • - The patients should not present any of the following criteria: - People 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, including anti-integrin antibodies (approved or investigational), 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 including: - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04183608
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Additional Details

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.#46;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

Arms & Interventions

Arms

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.

Active Comparator: Groupe T2T with telemonitoring and patient education

Treatment with e-Monitoring, home fecal calprotectin testing and therapy education.

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU Amiens- Picardie (site Sud), Amiens, France

Status

Recruiting

Address

CHU Amiens- Picardie (site Sud)

Amiens, , 80054

Site Contact

Mathurin Fumery

fumery.mathurin@chu-amiens.fr

04 92 03 65 75

CHU Caen Hôpital Côte de Nacre, Caen, France

Status

Withdrawn

Address

CHU Caen Hôpital Côte de Nacre

Caen, , 14033

CHU Estaing, Clermont-Ferrand, France

Status

Not yet recruiting

Address

CHU Estaing

Clermont-Ferrand, , 63003

Site Contact

Anthony Buisson

a_buisson@hotmail.fr

04 92 03 65 75

APHP - Hôpital Beaujon, Clichy, France

Status

Not yet recruiting

Address

APHP - Hôpital Beaujon

Clichy, , 92110

Site Contact

Yoram Bouhnik

yoram.bouhnik@aphp.fr

04 92 03 65 75

CH Colmar - Hôpital Pasteur, Colmar, France

Status

Not yet recruiting

Address

CH Colmar - Hôpital Pasteur

Colmar, , 68024

Site Contact

Daniel BENITAH

daniel.benitah@ch-colmar.fr

04 92 03 65 75

CHRU Lille Hôpital Claude Huriez, Lille, France

Status

Not yet recruiting

Address

CHRU Lille Hôpital Claude Huriez

Lille, , 59037

Site Contact

Maria Nachury

maria.nachury@CHRU-lille.fr

04 92 03 65 75

APHM - Hôpital Nord, Marseille, France

Status

Recruiting

Address

APHM - Hôpital Nord

Marseille, , 13915

Site Contact

Mélanie Serrero

MELANIE.SERRERO@ap-hm.fr

04 92 03 65 75

GHI Le Raincy-Montfermeil, Montfermeil, France

Status

Recruiting

Address

GHI Le Raincy-Montfermeil

Montfermeil, , 93370

Site Contact

Stéphane Nahon

snahon@ch-montfermeil.fr

04 92 03 65 75

CHU Montpellier - Hôpital Saint Eloi, Montpellier, France

Status

Not yet recruiting

Address

CHU Montpellier - Hôpital Saint Eloi

Montpellier, , 34295

Site Contact

Lucile Boivineau

l-boivineau@chu-montpellier.fr

04 92 03 65 75

CHU Nantes - Hôpital Hotel Dieu, Nantes, France

Status

Recruiting

Address

CHU Nantes - Hôpital Hotel Dieu

Nantes, , 44093

Site Contact

Caroline Trang

caroline.trang@chu-nantes.fr

04 92 03 65 75

CHU Nice- Hopital l'Archet, Nice, France

Status

Recruiting

Address

CHU Nice- Hopital l'Archet

Nice, , 62002

Site Contact

Xavier Hebuterne

hebuterne.x@chu-nice.fr

04 92 03 65 75

Nîmes, France

Status

Recruiting

Address

Chu nimes - Hôpital Universitaire Caremeau

Nîmes, , 30029

Site Contact

Ludovic Caillo

ludovic.caillo@chu-nimes.fr

04 92 03 65 75

CHU Bordeaux - Hôpital Haut Lévêque, Pessac, France

Status

Not yet recruiting

Address

CHU Bordeaux - Hôpital Haut Lévêque

Pessac, , 33604

Site Contact

David Laharie

david.laharie@chu-bordeaux.fr

04 92 03 65 75

CHU Lyon Sud, Pierre-Bénite, France

Status

Not yet recruiting

Address

CHU Lyon Sud

Pierre-Bénite, , 69495

Site Contact

Stéphane Nancey

stephane.nancey@chu-lyon.fr

04 92 03 65 75

CHU Rennes Hôpital Pontchaillou, Rennes, France

Status

Not yet recruiting

Address

CHU Rennes Hôpital Pontchaillou

Rennes, , 35033

Site Contact

Guillaume Bouguen

guillaume.bouguen@chu-rennes.fr

04 92 03 65 75

CH Saint Etienne Hopital Nord, Saint-Priest-en-Jarez, France

Status

Not yet recruiting

Address

CH Saint Etienne Hopital Nord

Saint-Priest-en-Jarez, , 42270

Site Contact

Xavier Roblin

xavier.roblin@chu-st-etienne.fr

04 92 03 65 75

CH Toulon - CHITS CH Sainte Musse, Toulon, France

Status

Withdrawn

Address

CH Toulon - CHITS CH Sainte Musse

Toulon, , 83056

CHU Toulouse - Hôpital Rangueil, Toulouse, France

Status

Recruiting

Address

CHU Toulouse - Hôpital Rangueil

Toulouse, , 31403

Site Contact

Cyrielle Gilletta

gilletta.c@chu-toulouse.fr

04 92 03 65 75

CH Tourcoing - Hôpital Gustave Dron, Tourcoing, France

Status

Not yet recruiting

Address

CH Tourcoing - Hôpital Gustave Dron

Tourcoing, , 59200

Site Contact

Noemie Tavernier

ntavernier@ch-tourcoing.fr

04 92 03 65 75

CHU Nancy - Hôpital de Brabois, Vandœuvre-lès-Nancy, France

Status

Not yet recruiting

Address

CHU Nancy - Hôpital de Brabois

Vandœuvre-lès-Nancy, , 54500

Site Contact

Laurent Peyrin-Biroulet

peyrinbiroulet@gmail.com

04 92 03 65 75

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