Greveling Mark, Ong Voon H, Denton Christopher, Foppen Wouter, Herman Amin, Jeffries-Owen Nick, Kortekaas Marion, Masselink Ilse, Mulder Douwe J, Schriemer Rita, Vonk Madelon C, de Vries-Bouwstra Jeska K, Welsing Paco, Mastbergen Simon, Spierings Julia
Department of Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands
Department of Medicine, Department of Inflammation, Centre for Rheumatology and Connective Tissue Diseases, University College London, London, UK.
BMJ Open. 2025 Mar 13;15(3):e095283. doi: 10.1136/bmjopen-2024-095283.
The majority of all patients with systemic sclerosis (SSc) experience hand function impairment. The exact cause for this impairment is yet unknown. As impaired hand function hugely impacts daily functioning and quality of life, there is a high unmet need for effective treatments. With the availability of new imaging modalities, biomarkers and laboratory techniques, opportunities arise to increase insights into the factors contributing to hand function impairment. The objective of this study is to identify risk factors and underlying mechanisms leading to hand function impairment in SSc.
This is a longitudinal observational multicentre study in patients with very early diagnosis of systemic sclerosis and SSc under care of the Department of Rheumatology and Clinical Immunology of the University Medical Centre Utrecht (UMCU), St Antonius Hospital Nieuwegein, UMC Groningen (UMCG), Leiden UMC (LUMC), Radboudumc or Royal Free Hospital (RFH) London. Patients will be followed for 2 years. Medical history, clinical status, nailfold capillaroscopy, skin assessments, serum biomarker analysis, ultrasound, elastography and MRI will be performed, and results related to hand function measurements will be analysed.
This study was approved by the Medical Research Ethics Committee NedMec (MREC NedMec) in the Netherlands and by HRA and Health and Care Research Wales in the UK. Results will be published in scientific journals and presented at scientific congresses and patient meetings.
NCT06133244.
V1.3 6-06-2024.
大多数系统性硬化症（SSc）患者存在手部功能障碍。这种功能障碍的确切原因尚不清楚。由于手部功能受损对日常活动和生活质量有巨大影响，因此对有效治疗存在高度未满足的需求。随着新的成像方式、生物标志物和实验室技术的出现，有机会加深对导致手部功能障碍因素的认识。本研究的目的是确定系统性硬化症患者手部功能障碍的危险因素及潜在机制。
这是一项纵向观察性多中心研究，研究对象为在乌得勒支大学医学中心（UMCU）、奈梅亨圣安东尼医院、格罗宁根大学医学中心（UMCG）、莱顿大学医学中心（LUMC）、拉德堡德大学医学中心或伦敦皇家自由医院（RFH）风湿病与临床免疫学系接受治疗的极早期诊断的系统性硬化症和SSc患者。患者将被随访2年。将进行病史、临床状况、甲襞毛细血管镜检查、皮肤评估、血清生物标志物分析、超声、弹性成像和MRI检查，并分析与手部功能测量相关的结果。
本研究已获得荷兰医学研究伦理委员会NedMec（MREC NedMec）以及英国的HRA和威尔士卫生与护理研究机构的批准。研究结果将发表在科学期刊上，并在科学大会和患者会议上展示。
NCT06133244。
V1.3 2024年6月6日。
