pfront autologous hematopoietic stem cell transplantation versus immunosuppressive medication in early diffuse cutaneous systemic sclerosis: an international multicentre, open-label, randomized controlled trial (UPSIDE) - NL72607.041.20

niversity Medical Center Utrecht0 个研究点目标入组 88 人开始时间: 2023年6月23日最近更新: 2024年8月21日

研究概览

暂无简介。

•Age between 18 and 65 years., Fulfilling the 2013 ACR-EULAR classification criteria, Disease duration = 3 years (from onset of first non-Raynaud's symptoms) and -mRSS = 15 (diffuse skin pattern) and/ or - clinically significant organ involvement as defined by either: a) respiratory involvement b) renal involvement c) cardiac involvement, OR Disease duration = 1 year and diffuse cutaneous disease with mRSS>10 and high risk ANA for organ based disease and/or acute phase response

•Pregnancy or unwillingness to use adequate contraception during study, concomitant severe disease (respiratory, renal, cardiac, liver failure, psychiatric disorders, concurrent neoplasms or myelodysplasia, bone marrow insufficiency, uncontrolled hypertension, uncontrolled acute or chronic infection, ZUBROD-ECOG-WHO PSS > 2, known hypersensitivity to any of the study drug constituents), Previous treatments with immunosuppressants > 12 months including MMF, methotrexate, azathioprine, rituximab, tocilizumab, glucocorticosteroids., Previous treatments with TLI, TBI or alkylating agents including CYC., Significant exposure to bleomycin, tainted rapeseed oil, vinyl chloride, trichlorethylene or silica, eosinophilic myalgia syndrome; eosinophilic fasciitis, Poor compliance of the patient as assessed by the referring physicians

发起方