A prospective, multi-centre, open-label, investigator-initiated randomised controlled study investigating calcinosis cutis in patients with systemic sclerosis undergoing treatment with sodium thiosulfate assessed by novel biomarkers and diagnostic imaging

Aarhus Universitetshospital0 个研究点目标入组 75 人开始时间: 2024年3月11日最近更新: 2024年7月22日

适应症

试验速览

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•SSc fulfilling ACA/EULAR 2013 criteria as well as patients with positive U1RNP and mixed connective tissue disease with overlap syndrome to SSc, Provides signed, written informed consent, Above 18 and under 90 years of age at baseline, Legally competent, able to give verbal, written and informed consent, Communicate in Danish verbally as well as in writing, Subject in good general health and willing to participate, Is willing and able to comply with the requirements of the protocol and to undergo all testing, Medications for SSc are stable for at least 6 weeks prior to study entry, If subjects received STS treatment on the selected lesion before, a washout period of 3 months must be complete upon study entry

•Individuals with other skin diseases in the skin area of interest, Individuals with CC of other causality, Individuals whose CC lesion is not accessible for imaging e.g., inside the ear, inside nostrils., Pregnancy, Breastfeeding, Women of child-bearing potential not using a contraceptive agent at the time of inclusion, Known hypersensitivity to STS

发起方

Aarhus Universitetshospital