Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 75 Years|
- - 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.
- - 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.
- - 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.
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.
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.
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|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
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.
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.
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.