[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603621":3},{"organization":4,"armGroups":7,"interventions":45,"overallOfficials":195,"centralContacts":199,"locations":209,"responsibleParty":221,"collaborators":51,"id":223,"slug":224,"hasResults":225,"nctId":226,"briefTitle":227,"officialTitle":227,"acronym":51,"eligibilityCriteria":228,"healthyVolunteers":225,"sex":229,"minAge":230,"maxAge":51,"enrollmentInfo":231,"targetDuration":51,"studyType":234,"phases":235,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":254,"whyStopped":51,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":264},{"fullName":5,"class":6},"NYU Langone Health","OTHER",[8,40],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard hold","ACTIVE_COMPARATOR","Patients will follow the standard perioperative immunosuppressant hold protocol based on guidelines from hip and knee arthroplasty literature. The duration of the hold is determined by medication half-life and infection risk considerations. Postoperatively, medications will be restarted approximately 2 weeks after surgery (+\u002F- 2 days), contingent on wound healing and infection status.",[13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Drug: Methotrexate","Drug: Sulfasalazine","Drug: Hydroxychloroquine","Drug: Leflunomide","Drug: Azathioprine","Drug: Mycophenolate","Drug: Cyclosporine","Drug: Tacrolimus","Drug: Etanercept","Drug: Adalimumab","Drug: Golimumab","Drug: Certolizumab","Drug: Infliximab","Biological: Rituximab","Biological: Belimumab","Biological: Tocilizumab","Biological: Anakinra","Biological: Canakinumab","Biological: Abatacept","Biological: Secukinumab","Biological: Ixekizumab","Biological: Bimekizumab","Biological: Ustekinumab","Biological: Guselkumab","Biological: Risankizumab","Drug: Tofacitinib","Drug: Upadacitinib",{"label":41,"type":42,"description":43,"interventionNames":44},"Shorter hold","EXPERIMENTAL","Patients will follow an abbreviated immunosuppressant hold protocol, withhold durations modified based on drug pharmacokinetics to allow a shorter preoperative discontinuation period. Medications will be prescribed as usual by the patient's rheumatologist, only adjusting the interval between last preoperative dose and surgery. The rheumatologist will relay the number of weeks\u002Fdays between the last dose and surgery date. Postoperatively, medications will be restarted approximately 1 week after surgery (+\u002F- 2 days), provided there are no signs of infection or wound healing complications. Route of Administration",[13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],[46,52,55,60,65,71,76,79,82,88,94,100,106,112,119,125,130,136,142,148,154,159,165,171,177,183,189],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"DRUG","Methotrexate","Continue throughout perioperative period",[41,9],null,{"type":47,"name":53,"description":49,"armGroupLabels":54,"otherNames":51},"Sulfasalazine",[41,9],{"type":47,"name":56,"description":49,"armGroupLabels":57,"otherNames":58},"Hydroxychloroquine",[41,9],[59],"Plaquenil",{"type":47,"name":61,"description":49,"armGroupLabels":62,"otherNames":63},"Leflunomide",[41,9],[64],"Arava",{"type":47,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"Azathioprine","Control group: Withhold the daily dose 1 week prior to surgery Intervention group: Withhold 2 days prior to surgery",[41,9],[70],"Imuran",{"type":47,"name":72,"description":67,"armGroupLabels":73,"otherNames":74},"Mycophenolate",[41,9],[75],"Cellcept",{"type":47,"name":77,"description":67,"armGroupLabels":78,"otherNames":51},"Cyclosporine",[41,9],{"type":47,"name":80,"description":67,"armGroupLabels":81,"otherNames":51},"Tacrolimus",[41,9],{"type":47,"name":83,"description":84,"armGroupLabels":85,"otherNames":86},"Etanercept","Control group: Schedule surgery 2 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose",[41,9],[87],"Enbrel",{"type":47,"name":89,"description":90,"armGroupLabels":91,"otherNames":92},"Adalimumab","Control group: Schedule surgery 3 weeks after last administered dose Intervention group: Schedule surgery 1 week after last administered dose",[41,9],[93],"Humira",{"type":47,"name":95,"description":96,"armGroupLabels":97,"otherNames":98},"Golimumab","Control group: Schedule surgery 5 weeks after last administered 4-week subcutaneous dose or 9 weeks after last administered 8-week intravenous dose.\n\nIntervention group: Schedule surgery 2 weeks after last administered 4-week subcutaneous dose or 4 weeks after last administered 8-week intravenous dose.",[41,9],[99],"Simponi",{"type":47,"name":101,"description":102,"armGroupLabels":103,"otherNames":104},"Certolizumab","Control group: Schedule surgery 5 weeks after last administered dose. Intervention group: Schedule surgery 2 weeks after last administered dose.",[41,9],[105],"Cimzia",{"type":47,"name":107,"description":108,"armGroupLabels":109,"otherNames":110},"Infliximab","Control group: Schedule surgery 9 weeks after last administered intravenous dose.\n\nIntervention group: Schedule surgery 4 weeks after last administered dose.",[41,9],[111],"Remicaide",{"type":113,"name":114,"description":115,"armGroupLabels":116,"otherNames":117},"BIOLOGICAL","Rituximab","Control: Schedule 7 months after last administered dose. Intervention group: Schedule 3 months after last administered dose.",[41,9],[118],"Rituxan",{"type":113,"name":120,"description":121,"armGroupLabels":122,"otherNames":123},"Belimumab","Control group: Schedule surgery 2 weeks after last administered subcutaneous weekly dose or 5 weeks after last administered 4-week intravenous dose.\n\nIntervention group: Schedule surgery 1 week after last administered weekly dose or 2 weeks after last administered 4-week dose.",[41,9],[124],"Benlysta",{"type":113,"name":126,"description":121,"armGroupLabels":127,"otherNames":128},"Tocilizumab",[41,9],[129],"Actemra",{"type":113,"name":131,"description":132,"armGroupLabels":133,"otherNames":134},"Anakinra","Control group: Schedule surgery 2 days after last administered daily dose. Experimental group: Schedule surgery 1 day after last administered daily dose.",[41,9],[135],"Kineret",{"type":113,"name":137,"description":138,"armGroupLabels":139,"otherNames":140},"Canakinumab","Control group: Schedule surgery 5 weeks after last administered 4-week dose. Intervention group: Schedule surgery 2 weeks after last administered 4-week dose.",[41,9],[141],"Ilaris",{"type":113,"name":143,"description":144,"armGroupLabels":145,"otherNames":146},"Abatacept","Control group: Schedule surgery 2 weeks after last administered weekly subcutaneous dose or 5 weeks after last administered monthly intravenous dose.\n\nIntervention group: Schedule surgery 1 week after last administered weekly subcutaneous dose or 2 weeks after last administered monthly intravenous dose.",[41,9],[147],"Orencia",{"type":113,"name":149,"description":150,"armGroupLabels":151,"otherNames":152},"Secukinumab","Control group: Schedule surgery 5 weeks after last administered subcutaneous dose.\n\nIntervention group: Schedule surgery 2 weeks after last administered subcutaneous dose.",[41,9],[153],"Cosentyx",{"type":113,"name":155,"description":138,"armGroupLabels":156,"otherNames":157},"Ixekizumab",[41,9],[158],"Taltz",{"type":113,"name":160,"description":161,"armGroupLabels":162,"otherNames":163},"Bimekizumab","Control group: Schedule surgery 9 weeks after last administered 8-week dose. Intervention group: Schedule surgery 4 weeks after last administered 8-week dose",[41,9],[164],"Bimzelx",{"type":113,"name":166,"description":167,"armGroupLabels":168,"otherNames":169},"Ustekinumab","Control group: Schedule surgery 13 weeks after last administered 12-week dose. Intervention group: Schedule surgery 6 weeks after last administered 12-week dose.",[41,9],[170],"Stelara",{"type":113,"name":172,"description":173,"armGroupLabels":174,"otherNames":175},"Guselkumab","Control group: Schedule surgery 9 weeks after last administered 8-week dose. Intervention group: Schedule surgery 4.5 weeks after last administered 8-week dose.",[41,9],[176],"Tremfya",{"type":113,"name":178,"description":179,"armGroupLabels":180,"otherNames":181},"Risankizumab","Control group: Schedule surgery 13 weeks after last administered 12-week dose. Intervention group: Schedule surgery 6-7 weeks after last administered 12-week dose.",[41,9],[182],"Skyrizi",{"type":47,"name":184,"description":185,"armGroupLabels":186,"otherNames":187},"Tofacitinib","Control group: Schedule surgery 4 days after last administered daily dose. Intervention group: Schedule surgery 2 days after last administered daily dose.",[41,9],[188],"Xeljanz",{"type":47,"name":190,"description":191,"armGroupLabels":192,"otherNames":193},"Upadacitinib","Control group: Withhold 4 days prior to surgery Intervention group: Withhold 2 days prior to surgery",[41,9],[194],"Rinvoq",[196],{"name":197,"affiliation":5,"role":198},"Jonathan Samuels, MD","PRINCIPAL_INVESTIGATOR",[200,205],{"name":201,"role":202,"phone":203,"phoneExt":51,"email":204},"Thomas Chalothron","CONTACT","646-501-7384","Thomas.Chalothron@nyulangone.org",{"name":206,"role":202,"phone":207,"phoneExt":51,"email":208},"Lauren Drillock","646-501-7388","Lauren.Drillock@nyulangone.org",[210],{"facility":5,"status":51,"city":211,"state":211,"zip":212,"country":213,"countryCode":214,"cosmosGeoPoint":215,"geoPoint":220,"contacts":51},"New York","10016","United States","US",{"type":216,"coordinates":217},"Point",[218,219],-74.00597,40.71427,{"lat":219,"lon":218},{"type":222,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR","100603621","phase-2-immunosuppressant-management-in-rheumatology-patients-undergoing-elective-total-shoulder-arthroplasty-100603621",false,"NCT07138898","Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty","Inclusion Criteria:\n\n1. Adults aged 18 years and older at the time of informed consent;\n2. Diagnosis of rheumatic disease: rheumatoid arthritis (RA), psoriatic arthritis (PA) , ankylosing spondylitis (AS), systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA), spondyloarthritis, polymyalgia rheumatica, giant cell arteritis, vasculitis, granulomatosis with polyangiitis, dermatomyositis, polymyositis, and inflammatory bowel disease-associated arthritis;\n3. On active immunosuppression for at least 3 months prior to scheduled surgery;\n4. Scheduled for elective total shoulder arthroplasty;\n5. Able and willing to provide written informed consent prior to any study specific procedures.\n\nExclusion Criteria:\n\n* Patients with active infections or malignancies;\n* Patients undergoing shoulder arthroplasty for fracture or tumor;\n* Pregnancy or breastfeeding;\n* Unable to provide informed consent;\n* Patients with severe SLE with marked activity - as they should be offered enrollment in the observational arm. All such patients should remain on treatment to avoid worsening of disease activity;\n* Unable or without capacity to provide written informed consent prior to any study specific procedures.","ALL","18 Years",{"count":232,"type":233},80,"ESTIMATED","INTERVENTIONAL",[236],"PHASE2","The purpose of this study is to assess the incidence of rheumatologic flares, changes in pain scores (VAS), changes in functional outcomes (PROMIS), wound complications, surgical site infections, and return trips to the operating room for rheumatology patients following shoulder replacements, comparing those who stop their immunosuppressants preoperatively for the same amount of time as suggested in the literature for hip and knee arthroplasty versus those who hold the medications for a shorter period of time preoperatively.",[239],"Rheumatic Disease",[241,242,243,244,245,246,247,248,249,250,251,252,253],"rheumatoid arthritis","psoriatic arthritis","ankylosing spondylitis","systemic lupus erythematosus","juvenile idiopathic arthritis","spondyloarthritis","polymyalgia rheumatica","giant cell arteritis","vasculitis","granulomatosis with polyangiitis","dermatomyositis","polymyositis","inflammatory bowel disease-associated arthritis","NOT_YET_RECRUITING","2025-08-18",{"date":257,"type":258},"2025-08-24","ACTUAL",{"date":260,"type":233},"2025-09",{"date":262,"type":233},"2027-09",{"name":5,"class":6},1]