[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Celltrion HealthCare France\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":62},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100625669",false,"NCT07425639","ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab Biosimilar","ROLL'YN-OMA : Etude Observationnelle de Cohorte Pour la Prise en Charge Des Patients Atteints de Pathologies Inflammatoires Chroniques traités Par Omlyclo®, un Omalizumab Biosimilaire","ROLL'YN-OMA","Inclusion Criteria:\n\n* Be an adult (aged 18 years or older at the time of inclusion) receiving specialist care and diagnosed with one of the following conditions: Severe asthma, Chronic Spontaneous Urticaria\n* Have been treated for at least 6 months prior to inclusion with the reference omalizumab for the relevant condition (Severe asthma or Chronic Spontaneous Urticaria).\n* Have been stable for at least 3 months according to the prescribing physician, with the disease controlled or in clinical remission based on the disease-specific activity score: Severe asthma: ≤ 1 course of oral corticosteroids per year related to disease worsening, without hospitalization, and ACQ \\\u003C 1.5 and FEV1 ≥ 80% of the patient's most recent values\u002F Chronic Spontaneous Urticaria : UCT ≥ 12\n* For whom the specialist physician has decided to switch to OMLYCLO® (biosimilar developed and marketed by Celltrion) on the day of patient inclusion (shared medical decision independent of the study).\n* Be able to start treatment within a maximum of 60 days following inclusion.\n* Have an email address.\n* Have a mobile phone number.\n* Be able to understand and complete questionnaires in French.\n* Not object to participating in the study.\n* Be affiliated with a French Social Security scheme or be a beneficiary of such a scheme\n\nExclusion Criteria:\n\n* Patients under guardianship or trusteeship, or otherwise deprived of liberty.\n* Pregnant women or women of childbearing potential with a desire to become pregnant during treatment with OMLYCLO®.\n* Patients who, at the time of inclusion, are participating in a clinical trial or another clinical study that prohibits simultaneous participation in other studies.\n* Contraindication to the study products.","ALL","18 Years",{"count":19,"type":20},225,"ESTIMATED","OBSERVATIONAL","ROLL'YN-OMA is a real-world study in patients receiving standard biologic therapies who have been in control and\u002For remission of their disease for at least 3 months and whose physician has independently decided, within the framework of a shared medical decision, to switch them to OMLYCLO®. The primary objective of this study is to evaluate the maintenance of this control and\u002For clinical remission 12 months after initiation of the biosimilar, and subsequently, patient satisfaction at 6 and 12 months.",[24,25],"Chronic Spontaneous Urticaria (CSU)","Allergic Asthma","RECRUITING","2026-02-16",{"date":29,"type":30},"2026-02-23","ACTUAL",{"date":32,"type":30},"2025-10-02",{"date":34,"type":20},"2028-09",{"name":36,"class":37},"Celltrion HealthCare France","INDUSTRY",1,{"id":40,"slug":4,"hasResults":10,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":47,"conditions":48,"keywords":51,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":38},"100592717","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.",{"count":19,"type":20},"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.",[49,50],"Crohn Disease","Plaque Psoriasis",[52,53],"Biosimilar","ustekinumab","2025-05-21",{"date":56,"type":30},"2025-05-30",{"date":58,"type":30},"2025-03-17",{"date":60,"type":20},"2027-12-31",{"name":36,"class":37},""]