[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100450766":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":38,"responsibleParty":58,"collaborators":61,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":31,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":31,"enrollmentInfo":77,"targetDuration":31,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":41,"whyStopped":31,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Administration of Brentuximab vedotin","EXPERIMENTAL","Maximum duration of treatment: 48 weeks Maximum dose allowed: 0.6 mg\u002Fkg Route of administration: intravenous",[13],"Drug: Brentuximab vedotin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Brentuximab vedotin","Dose 0.6mg\u002Fkg will be given every 3 weeks for 16 cycles (48 weeks), in addition to standard of care medications for SSc that may include cyclophosphamide, methotrexate, azathioprine, mycophenolate mofetil (MMF, cellcept) and mycophenolic acid (myfortic)",[9],[21],"ADCETRIS, SGN-35",[23],{"name":24,"affiliation":25,"role":26},"Janet E Pope, PhD","University of Western Ontario, Division of Rheumatology, St. Joseph's Health Care, London, Ontario, Canada","PRINCIPAL_INVESTIGATOR",[28,33],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","519-646-6332",null,"Janet.Pope@sjhc.london.on.ca",{"name":34,"role":29,"phone":35,"phoneExt":36,"email":37},"Amanda Philip","519-646-6000","61228","Amanda.Philip@sjhc.london.on.ca",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Rheumatology Clinic, St. Joseph's Health Care","RECRUITING","London","Ontario","N6A 4V2","Canada","CA",{"type":48,"coordinates":49},"Point",[50,51],-81.23304,42.98339,{"lat":51,"lon":50},[54,57],{"name":55,"role":29,"phone":30,"phoneExt":31,"email":56},"Janet E Pope","janet.pope@sjhc.london.on.ca",{"name":55,"role":26,"phone":31,"phoneExt":31,"email":31},{"type":26,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Janet Pope","Head of Rheumatology",[62,65],{"name":63,"class":64},"Seattle Genetics (now a wholly owned subsidiary of Pfizer)","UNKNOWN",{"name":66,"class":67},"Pfizer","INDUSTRY","100450766","phase-2-open-label-extension-study-of-brentuximab-vedotin-in-early-dcssc-100450766",false,"NCT05149768","Open Label Extension Study of Brentuximab Vedotin in Early dcSSc","An Open Label Extension Study of Brentuximab Vedotin Treatment in Active Diffuse Cutaneous Systemic Sclerosis (Diffuse Scleroderma)","Inclusion Criteria:\n\n1. Patients with diffuse cutaneous systemic sclerosis enrolled in the Phase II Adcetris study (BV201708) at St. Joseph's Health centre, aged 18 years or older, and:\n2. Worsening mRSS of ≥ 4 points as compared to mRSS score at the end of treatment visit (week 48) in the initial study (BV201708).\n3. Able to give informed consent.\n\nExclusion Criteria:\n\n1. Poor pulmonary function (FVC\\\u003C40% and\u002For DLCO\\\u003C30%).\n2. Pregnancy, breast feeding or child bearing potential without practicing highly effective contraception (and partners for men in the study).\n3. Clinically significant pulmonary hypertension requiring drug therapy.\n4. Clinically significant cardiac disease.\n5. Chronic or ongoing active infectious disease requiring systemic treatment.\n6. Seropositivity for human immunodeficiency virus (HIV).\n7. Active tuberculosis (TB) infection.\n8. Active viral infection with viral replication of hepatitis B or C virus.\n9. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, pancreatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease; and cancer.\n10. Peripheral neuropathy at screening Grade 2 or higher.\n11. Known or suspected hypersensitivity to components of the treatment\n12. Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder)\n13. Any of the following laboratory abnormalities at screening:\n\n    * Absolute neutrophils count \\\u003C2.0 x 109\u002FL\n    * Hemoglobin \\\u003C85 g\u002FL\n    * Platelet count \\\u003C 100 x 109\u002FL\n    * AST\u002FSGOT or ALT\u002FSGPT \\>2.0 UNL\n14. Participation in another clinical trial within six weeks before randomization in this study, with the exception of continuation from the initial study BV201708.\n15. Use of rituximab within the previous 4 months.\n16. Immunization with a live\u002F attenuated vaccine less than 4 weeks prior to the baseline visit.\n17. Current or history of progressive multifocal leukoencephalopathy (PML).","ALL","18 Years",{"count":78,"type":79},11,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","The purpose of this study is to assess safety and efficacy of Brentuximab vedotin, a CD30-directed antibody-drug conjugate, in patients with active diffuse cutaneous systemic sclerosis (dcSSc) who relapsed after discontinuation of Brentuximab vedotin.",[85],"Diffuse Cutaneous Systemic Sclerosis",[87,88,89,90,91,92,93,94],"systemic sclerosis","scleroderma","brentuximab vedotin","CD30-directed antibody-drug conjugate","antirheumatic agents","antineoplastic agents","skin diseases","immunologic factors","2024-11-14",{"date":97,"type":98},"2024-11-18","ACTUAL",{"date":100,"type":98},"2024-02-14",{"date":102,"type":79},"2026-07-01",{"name":5,"class":6},1]