[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":164},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,45,71,95,120,141],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100640448","phase-4-optimal-care-with-guselkumab-in-crohns-disease--optim-study-a-prospective-open-label-interventional-multicenter-study-100640448",false,"NCT07616687","Optimal Care With Guselkumab in Crohn's Disease \u002F OPTIM Study A Prospective Open Label Interventional, Multicenter Study","Optimal Care With Guselkumab In Crohn's Disease","OPTIM","Inclusion Criteria:\n\n* \\- Patients with a diagnosis of CD according to ECCO guidelines,\n* 18 years of age or older at the time of informed consent,\n* Absence of contraindication to guselkumab,\n* Active disease according to PRO2 (abdominal pain \\> 1 or stool frequency \\> 3), and faecal calprotectin \\> 250 ug\u002Fg,\n* Objective active disease documented within ≤ 2 months by endoscopy or by MRI when not contraindicated, orby IUS),\n* Not currently participating in any interventional research.\n* Patient naïve or exposed to one or more advanced therapy, in accordance with the approved indication for guselkumab in Crohn's disease.\n* Females of childbearing potential must have a negative serum pregnancy test at the baseline Visit.\n\nExclusion Criteria:\n\n* \\- Patient under legal protection,\n* Previous exposure to an anti-IL23\n* Combination of advanced therapy with GUS,\n* Patient with ostomy,\n* Pregnant or breastfeeding woman,\n* Patient with perianal CD predominant disease.\n* Active clinically significant infection or HIV, Hep B, Hep C, or active tuberculosis","ALL","18 Years",{"count":20,"type":21},210,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Crohn's disease (CD) is a chronic and destructive inflammatory disease of the gastrointestinal tract characterized by phases of relapse and remission. Tumor necrosis factor (TNF) antagonists, anti-integrins and anti-interleukin (IL) 12\u002F23 are the main therapeutic agents to obtain deep remission and prevent disability. Despite the significant advances these biologics represent in treating inflammatory bowel disease (IBD), many patients experience suboptimal responses, including primary non-response or a loss of effectiveness over time, often leading to treatment discontinuation. For all these medications, a dose-response relationship has been demonstrated and an increase in dose or dosing frequency is recommended. Dose escalation is now an essential therapeutic approach necessary in 30 to 50% of CD patients treated with biologics. This strategy, supported by international guidelines, allows for long-term efficacy to be maintained without compromising safety.\n\nGuselkumab (GUS) is a monoclonal antibody targeting the p19 subunit of IL-23. In a recent phase III trial (GALAXI), GUS demonstrated superiority of both subcutaneous (SC) maintenance doses (200 mg every 4 weeks \\[q4w\\] and 100 mg every 8 weeks \\[q8w\\]) compared to placebo and ustekinumab. In the GALAXI phase III program, at least 30% of patients did not achieve clinical response after a 12-week intravenous induction, and almost 20% experienced a loss of response by week 44. In these patients, the benefit of an intensified dose of GUS (200 mg q4w) maintenance remains to be determined to guide clinicians in optimizing its use in clinical practice. The investigator aimed to evaluate the one-year effectiveness of GUS in CD in real-world settings and under optimal conditions allowing dose intensification.",[27,28],"Crohn Disease (CD)","Intensification",[30,28,31],"Crohn's disease","Guselkumab","RECRUITING","2026-06-26",{"date":35,"type":36},"2026-06-30","ACTUAL",{"date":38,"type":36},"2026-06-18",{"date":40,"type":21},"2029-03-15",{"name":42,"class":43},"Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":5},"100615392","phase-4-efficacy-of-mirikizumab-to-achieve-transmural-healing-in-patients-with-crohns-disease-100615392","NCT07292012","Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease","Efficacy of MIrikizumab to Achieve Transmural Healing in patiENTs With Crohn's Disease : EMINENT-CD","EMINENT-CD","Inclusion Criteria:\n\n* Patients with CD\n* ≥ 18 to ≤ 75 years-old\n* Symptomatic CD according to PRO-2 (stool \\> 3 or abdominal pain score \\> 1)\n* Transmural inflammation on baseline MRI (C-score \\> 0.5 in at least one segment)\n\nExclusion Criteria:\n\n* Prior exposure to anti-p19 biological therapy\n* Exposure to more than 1 class of advanced therapies at a dose approved for the treatment of Crohn's disease (janus kinase \\[JAK\\] inhibitors, infliximab, adalimumab, certolizumab pegol, vedolizumab, ustekinumab, or approved biosimilars for these agents\n* Exclude any previous use of p19 IL23s agents\n* Contra-indication to mirikizumab\n* Definitive ostomy\n* Colectomy with IPAA\n* Isolated or uncontrolled perianal lesions\n* Severe obstructive symptoms\n* Intra-abdominal abscess\n* Contra-indication to MRI\n* No health insurance\n* Pregnant or lactating women\n* Patients already included in biomedical research other than an observational study (e.g., registry, cohort)\n* Concomitant Clostridioides difficile infection\n* HIV infection\n* Patient under guardianship, curatorship or safeguard of justice","75 Years",{"count":55,"type":21},75,[24],"Efficacy of Mirikizumab to achieve transmural healing in patients with Crohn's Disease",[27],[60,61,62],"crohn's disease","transmural healing","mirikizumab","2026-05-21",{"date":65,"type":36},"2026-05-26",{"date":67,"type":36},"2026-05-11",{"date":69,"type":21},"2028-11",{"name":42,"class":43},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":92,"leadSponsor":94,"locationsCount":44},"100573138","evaluation-of-a-remote-monitoring-application-in-the-follow-up-of-patients-with-active-inflammatory-bowel-diseases-100573138","NCT06742385","Evaluation of a Remote Monitoring Application in the Follow-up of Patients With Active Inflammatory Bowel Diseases","Evaluation of a Remote Monitoring Application in the Follow-up of Patients With Active Inflammatory Bowel Diseases: The SECURITY Trial","SECURITY","Inclusion Criteria:\n\n* CD\u002FUC patients with a validated diagnosis\n* Patients age \\> 18 years\n* IBD with clinical signs of PRO2 activity leading to modification of medical treatment: introduction of a new treatment, or change of dose or addition of a treatment (corticoids, ASA, IS, biotherapy (a 4 week induction phase is authorized\n* Patients willing and able to participate in the collection of data via SEMEIA App on their smartphone\n* Patients agreeing to participate for 12 months\n\nExclusion Criteria:\n\n* Patients with an inability to use a smartphone and email\n* Patients \\\u003C 18 years old\n* Digestive surgery expected within 3 months\n* Pregnancy at baseline\n* Patients with an history of sub-total colectomy, coloproctectomy, digestive ostomy, extensive or multiple intestinal resections with sequelae of diarrhoea, short bowel syndrome.\n* Patients who have had recent digestive surgery (ileal resection \\\u003C 6 months) Patients with any other uncontrolled somatic or psychiatric pathology\n* Patients enrolled in a trial with an investigational treatment","80 Years",{"count":81,"type":21},290,[83],"NA","Telemonitoring is of definite theoretical interest for patients suffering from chronic diseases and could help to improve monitoring of treatment efficacy and tolerance, and hence remission and quality of life. Reimbursement is now planned in France for devices that have demonstrated a positive effect on patient intake. However, available studies testing different tools in IBD have shown no significant improvement in disease control or quality of life. Nevertheless, major secondary endpoints such as reduced hospitalization, complications and healthcare costs have been demonstrated. Several biases have been identified to explain these disappointing results, such as the heterogeneity of the tools\u002Fapplications tested, methodological limitations concerning the main objective and technological limitations of the tools evaluated.\n\nWe propose here to evaluate the impact of a tight remote monitoring through digital tool on disease control, in patients with active IBD, thanks to the MedicWise platform. The technology of the MedicWise solution enables the automatic collection of a wide range of biological and healthcare consumption data, thus limiting the need for patient input. MedicWise has obtained the CE label and is already used and reimbursed in France in other chronic diseases. The SECURITY trial proposes to evaluate the impact of a tight remote monitoring through digital tool on time spent in remission. Improvement of IBD related disability is also a major secondary objective of the study. It also has the following secondary objectives to analyze the impact of this tool on the organization of care teams caring for patients with IBD.",[86,87],"Crohn Disease","Ulcerative Colitis","2025-09-18",{"date":90,"type":36},"2025-09-24",{"date":88,"type":36},{"date":93,"type":21},"2028-09-18",{"name":42,"class":43},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":102,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":105,"conditions":106,"keywords":108,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},"100522974","ibd-cancer-and-serious-infections-in-france-i-care-2-100522974","NCT06089590","Ibd CAncer and seRious Infections in France (I-CARE 2)","I-CARE 2","Inclusion Criteria:\n\n* Patient with an established diagnosis of Crohn's disease, ulcerative colitis or IBD unclassified based on usual radiological, endoscopic or histological criteria.\n* Patient aged 18 and older accepting to sign the informed participating consent form, stating that he accepts to provide personal details (mobile and home phone number, e-mail address), to complete the e-PRO as required and to be contacted by a Study Coordinator and his gastroenterologist for the purpose of the study during the entire study period and during follow up if required.\n\nExclusion Criteria:\n\n* Patient unable to sign the informed consent form\n* Patient with no regular access to internet\n* Patient refusing to sign the informed consent form\n* Patient enrolled in a Randomized Clinical Trial (If the investigational product received was blinded, and if the treatment is unknown at time of enrolment in I-CARE 2)",{"count":103,"type":21},6000,"OBSERVATIONAL","This is a French prospective longitudinal observational multicentre cohort study.\n\nPrimary objective : to assess prospectively the presence and the extent of safety concerns (cancer, serious infections, arterial and venous thrombotic events) in patients with CD and UC and treated with JAKi, anti-IL23p19, and S1p modulators.",[107,87,86],"IBD",[109,110],"UC","CD","2025-03-12",{"date":113,"type":36},"2025-03-14",{"date":115,"type":36},"2024-01-25",{"date":117,"type":21},"2031-03-01",{"name":42,"class":43},2,{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":128,"targetDuration":4,"studyType":104,"phases":4,"briefSummary":129,"conditions":130,"keywords":131,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},"100508641","transmural-healing-definition-in-crohns-disease-trench-1-100508641","NCT05903066","TRansmural hEaliNg Definition in CroHn's Disease (TRENCH 1)","TRansmural hEaliNg Definition in CroHn's Disease - The TRENCH1 Study","TRENCH 1","Inclusion Criteria:\n\n* ≥ 18 years of age\n* Patient diagnosed with CD for more than 6 months with histological confirmation available in his medical record.\n* Indication for MRE based on routine clinical practice validated by the treating physician\n* Any CD treatment will be authorized, such as biologicals (infliximab, adalimumab, vedolizumab, ustekinumab…), or immunomodulators (azathioprine, 6-mercaptopurine, methotrexate…).\n* The subjects sign and date a written, informed consent form and any required privacy authorization prior to the initiation of the study.\n* A subject can be enrolled into the study only if the grade of TH (assessed by the LRP) corresponding to the subject is not already fulfilled.\n\nExclusion Criteria:\n\n* Pregnancy during the study\n* People unable to give consent (because of their physical or mental state)\n* Absence of written consent\n* Ulcerative colitis or unclassified IBD\n* Specific postsurgical settings: ileoanal anastomosis, ileostomy or colostomy.\n* Less than 3 evaluable ileocolic segments or more than 3 resected ileocolonic segments (not counting ileocecal valve)\n* Severe obstructive symptoms\n* Symptomatic intra-abdominal abscess\n* Contraindication for MRI\n* Isolated perianal disease without luminal location\n* MRE images of poor quality, based on previously defined criteria",{"count":20,"type":21},"Multicenter prospective cross-sectional study of CD patients, its aim is the construction of an objective and reproducible system for evaluation of Transmural healing in Crohn's Disease (CD).\n\nPrimary objective : Objective definition of depth or grade of transmural healing in relation to radiologic signs observed during Magnetic Resonance Enterography (MRE) in CD",[86],[107,110],"2024-10-04",{"date":134,"type":36},"2024-10-08",{"date":136,"type":36},"2023-09-28",{"date":138,"type":21},"2025-08",{"name":42,"class":43},18,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":154,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},"100376598","phase-4-a-trial-comparing-standard-of-care-versus-treat-to-target-with-telemonitoring-and-patient-education-in-patients-with-ulcerative-colitis-initiating-adalimumab-100376598","NCT04183608","A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab","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","Inclusion Criteria:\n\n* 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* Age ≥ 18 years and \\\u003C 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* 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.\n* A contraceptive method during the whole trial for childbearing potential female\n* Patient familiar with Smartphone and internet use\n\nExclusion Criteria:\n\n* Patients unable to give their consent (because of their physical or mental state).\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.\n* Contraindication to anti-TNF therapy according to drug labeling:\n\n  * Active infection.\n  * Non-treated latent tuberculosis.\n  * Heart failure (NYHA: Grade III and IV).\n  * Malignancy during the previous 5 years.\n  * Demyelinating neurological disease.\n  * 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",{"count":150,"type":21},238,[24],"PHASE: IV\n\nDESCRIPTIVE: Randomized, interventional, open label multicenter trial\n\nPOPULATION: Moderate to severe ulcerative colitis\n\nSTUDY TREATMENTS: Patients will all receive Adalimumab 160\u002F80\u002F40mg 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\u002For investigator preference) for two months and then could be optimized up to 80mg EOW (or 40 EW according to patient and\u002For investigator preference) and azathioprine (2.0\u002F2.5 mg\u002Fkg\u002F day) or methotrexate (25 mg EW) until V3 (W 38).\n\nOBJECTIVES: 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®).",[87],[107,109],"2023-05-30",{"date":157,"type":36},"2023-05-31",{"date":159,"type":36},"2020-01-14",{"date":161,"type":21},"2028-05",{"name":42,"class":43},24,""]