[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649389":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":37,"responsibleParty":49,"collaborators":51,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":18,"enrollmentInfo":65,"targetDuration":18,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":78,"whyStopped":18,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Ottawa Hospital Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Mycophenolate mofetil (MMF)","EXPERIMENTAL","MMF 1000mg p.o. b.i.d. starting at day 90 post-AHSCT. This proposed MMF regimen is used in the management of rheumatic diseases and described in current literature and clinical guidelines. Duration of 6 months",[13],"Drug: Mycophenolate Mofetil 1000 mg twice daily",{"label":15,"type":16,"description":17,"interventionNames":18},"Control arm","NO_INTERVENTION","No scleroderma prophylaxis (current standard of care)",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Mycophenolate Mofetil 1000 mg twice daily","MMF 1000mg p.o. b.i.d. starting at day 90 post-AHSCT and continued for 6 months.",[9],[26],{"name":27,"affiliation":28,"role":29},"Nancy Maltez, Dr","The Ottawa Hospital","PRINCIPAL_INVESTIGATOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Clinical Research Assistant","CONTACT","613 738 8400","81630","nasaidi@ohri.ca",[38],{"facility":28,"status":18,"city":39,"state":40,"zip":18,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":18},"Ottawa","Ontario","Canada","CA",{"type":44,"coordinates":45},"Point",[46,47],-75.69812,45.41117,{"lat":47,"lon":46},{"type":50,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[52],{"name":53,"class":54},"The Ottawa Hospital Academic Medical Organization (TOHAMO) Innovation Fund Grant.","UNKNOWN","100649389","phase-2-mycophenolate-after-stem-cell-transplant-for-systemic-sclerosis-100649389",false,"NCT07734012","Mycophenolate After Stem Cell Transplant for Systemic Sclerosis","Immunomodulatory Maintenance Therapy Post-Autologous Hematopoietic Stem Cell Transplantation for Prevention of Systemic Sclerosis Relapse: A Pilot Randomized Trial","IMPACT-SSc","Inclusion Criteria:\n\n* Consenting participants 18 years of age or older who are initiating AHSCT at The Ottawa Hospital for management of SSc.\n\nExclusion Criteria:\n\n* Exclusion criteria are focused on patient safety, namely inability to receive treatment with\n\nMMF due to contraindications as determine at time of randomization (day 90 \u002F clinic visit #3) including:\n\n* Renal insufficiency (eGFR \\\u003C25 mL\u002Fminute\u002F1.73m2) or\n* Neutropenia (ANC \\\u003C1.0 x 103\u002FmcL) or\n* Thrombocytopenia (platelet count \\\u003C50 000\u002FmcL)\n* Previously documented intolerance.\n* Pregnant or breastfeeding - Women of childbearing potential who are not willing to use a highly effective method of contraception for the duration of study participation will be excluded","ALL","18 Years",{"count":66,"type":67},6,"ESTIMATED","INTERVENTIONAL",[70],"PHASE2","A pilot single center randomized trial to test whether a full-scale RCT evaluating the role of post-AHSCT maintenance immunosuppression with MMF in preventing disease relapse is feasible .\n\nWe are studying whether a brief course of treatment with MMF after AHSCT will serve to prevent disease relapse.",[73],"Systemic Sclerosis (SSc)",[75,76,77],"Systemic sclerosis","Stem cell transplant","Mycophenolate mofetil","NOT_YET_RECRUITING","2026-08-05",{"date":81,"type":82},"2026-08-07","ACTUAL",{"date":84,"type":67},"2026-08",{"date":86,"type":67},"2029-12",{"name":5,"class":6},1]