TY - JOUR
T1 - Hand function impairment in Systemic sclerosis
T2 - Outcomes, Mechanisms and Experience (HANDSOME) - a longitudinal observational multicentre study protocol
AU - Greveling, Mark
AU - Ong, Voon H
AU - Denton, Christopher
AU - Foppen, Wouter
AU - Herman, Amin
AU - Jeffries-Owen, Nick
AU - Kortekaas, Marion
AU - Masselink, Ilse
AU - Mulder, Douwe J
AU - Schriemer, Rita
AU - Vonk, Madelon C
AU - de Vries-Bouwstra, Jeska K
AU - Welsing, Paco
AU - Mastbergen, Simon
AU - Spierings, Julia
N1 - Publisher Copyright:
© 2025 BMJ Publishing Group. All rights reserved.
PY - 2025/3/13
Y1 - 2025/3/13
N2 - INTRODUCTION: 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.METHODS AND ANALYSIS: 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.ETHICS AND DISSEMINATION: 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.TRIAL REGISTRATION NUMBER: NCT06133244.PROTOCOL VERSION: V1.3 6-06-2024.
AB - INTRODUCTION: 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.METHODS AND ANALYSIS: 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.ETHICS AND DISSEMINATION: 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.TRIAL REGISTRATION NUMBER: NCT06133244.PROTOCOL VERSION: V1.3 6-06-2024.
KW - Biomarkers/blood
KW - Female
KW - Hand/physiopathology
KW - Humans
KW - Longitudinal Studies
KW - Magnetic Resonance Imaging
KW - Multicenter Studies as Topic
KW - Observational Studies as Topic
KW - Quality of Life
KW - Risk Factors
KW - Scleroderma, Systemic/complications
UR - http://www.scopus.com/inward/record.url?scp=105000258993&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2024-095283
DO - 10.1136/bmjopen-2024-095283
M3 - Article
C2 - 40082008
SN - 2044-6055
VL - 15
JO - BMJ Open
JF - BMJ Open
IS - 3
M1 - e095283
ER -