[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592717":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":28,"locations":34,"responsibleParty":46,"collaborators":48,"id":52,"slug":10,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":10,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Celltrion HealthCare France","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"CD group",null,"Switch from ustekinumab originator in patients with Crohn's disease",[13,14],"Drug: Ustekinumab 45 mg","Drug: Ustekinumab 90 mg",{"label":16,"type":10,"description":17,"interventionNames":18},"Psoriasis Group","Switch from ustekinumab originator in patients with Plaque Psoriasis",[13,14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DRUG","Ustekinumab 45 mg","biosimilar",[9,16],{"type":21,"name":26,"description":23,"armGroupLabels":27,"otherNames":10},"Ustekinumab 90 mg",[9,16],[29],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Salim BENKHALIFA, MD","CONTACT","+33 1 71 25 27 00","etudescliniques_fr@celltrionhc.com",[35],{"facility":36,"status":37,"city":38,"state":10,"zip":10,"country":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":10},"CHU Amiens","RECRUITING","Amiens","France",{"type":41,"coordinates":42},"Point",[43,44],2.3,49.9,{"lat":44,"lon":43},{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[49],{"name":50,"class":51},"Sanoia","OTHER","100592717",false,"NCT06997055","ROLL'YN-UST: an Observational Study in Patients Treated by Steqeyma®, an Ustekinumab Biosimilar","ROLL'YN-UST: Etude Observationnelle de Cohorte Pour la Prise en Charge Des Patients Atteints de Pathologies Inflammatoires Chroniques traités Par Steqeyma®, un Biosimilaire de l'ustékinumab","ROLL'YN-UST","Inclusion Criteria:\n\n* Be an adult (18 years of age or older at the time of inclusion) followed in specialty care and diagnosed with of one of the following conditions: Crohn's disease, Plaque psoriasis\n* Treated for at least 6 months prior to inclusion with the reference Ustekinumab for the pathology in question: Crohn's disease, Plaque psoriasis\n* Stable for at least 3 months according to the prescribing physician and in clinical remission according to the specific disease activity score.\n* For whom the specialist has decided to switch to the biosimilar treatment developed and marketed by Celltrion on the day of inclusion (shared medical decision independent of the study)\n* Have an email address.\n* Have a mobile phone number.\n* Be able to understand and complete questionnaires in French.\n* Not opposed to participating in the study.\n* Be affiliated to a French Social Security scheme or be a beneficiary of such a scheme.\n\nExclusion Criteria:\n\n* Patients under guardianship or otherwise deprived of their freedom.\n* Pregnant women or women of childbearing potential who wish to become pregnant while taking one of the study treatments.\n* Patients participating at the time of inclusion in a clinical trial or other clinical study that prohibits simultaneous participation in other studies.\n* Contraindication to study products.","ALL","18 Years",{"count":62,"type":63},225,"ESTIMATED","OBSERVATIONAL","ROLL'YN-UST is a real-life study, which includes patients in clinical remission for at least 3 months and who have been treated with a reference biotherapy for at least 6 months, and for whom the physician has decided, independently of the study and as part of a shared medical decision, to switch them to STEQEYMA®. The main aim of this study is to the maintenance of clinical remission 12 months after initiation of a biosimilar as well as patient satisfaction 6 and 12 months after initiation of a biosimilar.",[67,68],"Crohn Disease","Plaque Psoriasis",[70,71],"Biosimilar","ustekinumab","2025-05-21",{"date":74,"type":75},"2025-05-30","ACTUAL",{"date":77,"type":75},"2025-03-17",{"date":79,"type":63},"2027-12-31",{"name":5,"class":6},1]