[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Janssen Scientific Affairs, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":56},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"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},"100391063","a-study-to-assess-the-long-term-safety-of-ustekinumab-versus-other-biologics-in-patients-with-crohns-disease-and-ulcerative-colitis-100391063",false,"NCT04372108","A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis","An Observational Study to Assess the Long-term Safety of Ustekinumab Versus Other Biologic Therapies Among Patients With Crohn's Disease and Ulcerative Colitis: A New-User Cohort Study Using the Department of Defense Electronic Health Records Database","Inclusion Criteria:\n\n* Adult men and women with CD or UC who are new users of ustekinumab or the comparator drugs during the study period\n* Participants must have at least 1 year of enrollment history with the DoD EHR database immediately prior to new use (that is, exposure index date) of ustekinumab or the comparator drugs\n\nExclusion Criteria:\n\n* Participants below 18 years of age on the exposure index date\n* Participants who do not meet the definition for CD or UC prior to or on the exposure index date\n* Participants with any records of human immunodeficiency virus (HIV) diagnosis, organ or tissue transplant, or malignancy (excluding non-melanoma skin cancer \\[NMSC\\]) at any time prior to or on the exposure index date\n* Participants with a physician diagnosis of rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis within 12 months prior to or on the exposure index date\n* In the analysis of infection outcomes, participants diagnosed with the same infection of interest both within 60 days prior to or on the exposure index date and within 60 days after the exposure index date will be excluded","ALL","18 Years",{"count":19,"type":20},1056,"ESTIMATED","OBSERVATIONAL","The purpose of this study is to estimate and compare the incidence of overall malignancy, serious infection, and opportunistic infections between new users of ustekinumab and new users of other biologic therapies among adult participants with Crohn's disease (CD) or ulcerative colitis (UC).",[24,25],"Crohn Disease","Colitis, Ulcerative","RECRUITING","2026-05-07",{"date":29,"type":30},"2026-05-08","ACTUAL",{"date":32,"type":30},"2021-06-24",{"date":34,"type":20},"2030-08-30",{"name":36,"class":37},"Janssen Scientific Affairs, LLC","INDUSTRY",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":46,"phases":4,"briefSummary":47,"conditions":48,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":54,"locationsCount":55},"100465908","expanded-access-program-eap-for-ciltacabtagene-autoleucel-cilta-cel-out-of-specification-oos-in-participants-with-multiple-myeloma-100465908","NCT05346835","Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-Cel) Out-of-Specification (OOS) in Participants With Multiple Myeloma","Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS) in Patients With Multiple Myeloma","Inclusion Criteria:\n\n* Eligible for treatment with cilta-cel per United States Prescribing Information (USPI)\n* Has serious or life-threatening multiple myeloma per USPI, and where re-apheresis, re-manufacturing, or other anti-myeloma directed therapy is not considered feasible or adequate per treating physician discretion\n* Favorable participant benefit\u002Frisk assessment determined by Janssen medical review\n* Treating physician confirms the favorable risk benefit profile, and that proceeding with this treatment is in the best interest of the participant\n* Able to provide informed consent indicating they understand the purpose of this expanded access program (EAP)\n* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \\[beta-hCG\\]) pregnancy test during screening and prior to the first dose of cyclophosphamide and fludarabine","EXPANDED_ACCESS","The purpose of this expanded access program (EAP) is to provide ciltacabtagene autoleucel (cilta-cel) that does not meet the commercial release specifications of CARVYKTI and is not available via the local health care system in the country where the treatment is requested.",[49],"Multiple Myeloma","AVAILABLE","2026-02-12",{"date":53,"type":30},"2026-02-13",{"name":36,"class":37},138,""]