Adalimumab for Ulcerative colitis

Inclusion criteria

• {"criterion_text":"- 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\n- A contraceptive method during the whole trial for childbearing potential female\n- Patient familiar with Smartphone and internet use\n- Age ≥ 18 years and < 75 years\n- Patients scheduled to start a treatment with adalimumab\n- Naïve to anti-TNF therapy and other biologics known to be effective for UC (approved or investigational) except for vedolizumab\n- Naïve to JAK inhibitors (approved or investigational)\n- 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)\n- Established diagnosis of UC for at least 3 months (pancolitis, left-sided colitis, proctosigmoiditis and proctitis are allowed)\n- Patient has to be treated with oral 5-ASA at time of inclusion regardless of the dose if no contra-indication\n- Azathioprine, 6-mercaptopurine or methotrexate will be stopped two weeks before inclusion."}

Exclusion criteria

• {"criterion_text":"- People unable to give their consent (because of their physical or mental state).\n- 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\n- Patients with a dominant arm deficiency or physical impairment impeding the achievement of the tests\n- Patients using a prohibited medication\n- Patients participating in another trial or being in a follow-up period for another trial\n- Absence of written consent.\n- Pregnancy or breastfeeding.\n- Patients with severe acute colitis or patients at imminent risk for colectomy.\n- History of colectomy.\n- History of colonic mucosal dysplasia or adenomatous colonic polyps that are not removed.\n- Screening stool trial positive for enteric pathogens or Clostridium difficile toxin.\n- 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)\n- 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."}

Primary endpoints

• {"endpoint_text":"- At week 48 success defined by Endoscopic remission defined by an endoscopic Mayo score 0","definition_or_measurement_approach":"Endoscopic remission measured as an endoscopic Mayo score of 0 at Week 48."}

Secondary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Clinical remission defined as total Mayo score ≤ 2 with no individual subscore >1 and Mayo endoscopy subscore 0 or 1."}
• {"endpoint_text":"- Remission without steroids","definition_or_measurement_approach":""}
• {"endpoint_text":"- Endoscopic healing rate with Mayo score 0 or 1","definition_or_measurement_approach":"Endoscopic healing defined as Mayo endoscopy subscore 0 or 1."}
• {"endpoint_text":"- UCEIS score","definition_or_measurement_approach":""}
• {"endpoint_text":"- Histological healing (Nancy score)","definition_or_measurement_approach":"Histological healing assessed by Nancy score."}
• {"endpoint_text":"- Remission rate and remission rate without steroids at study visits and W48","definition_or_measurement_approach":""}
• {"endpoint_text":"- Quality of life evolution (evaluate visit 0 vs W14, W26, W38 and W48)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Patients satisfaction","definition_or_measurement_approach":""}
• {"endpoint_text":"- Continuous response","definition_or_measurement_approach":""}
• {"endpoint_text":"- Safety and tolerability","definition_or_measurement_approach":""}
• {"endpoint_text":"- Anti-TNF pharmacokinetics","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of visits in trial","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of UC related hospitalizations","definition_or_measurement_approach":""}
• {"endpoint_text":"- Number of colectomies","definition_or_measurement_approach":""}
• {"endpoint_text":"- Treatment compliance (questionnaire)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Patient adhesion (questionnaire)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Medico-economic analysis","definition_or_measurement_approach":""}

France

Earliest CTIS Part Ii Submission Date

03-05-2024

Latest Decision Or Authorization Date

28-05-2024

Processing Time Days

25

Number Of Sites

25

Number Of Participants

238

Primary sponsor

Full Name

Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"Abbvie","duties_or_roles":"Monetary support","organisation_type":""}