Hand function impairment in Systemic sclerosis: Outcomes, Mechanisms and Experience (HANDSOME) – a longitudinal observational multicentre study protocol

BMJ Open, vol. 15, pp. e095283

Abstract

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.

Authors 15

1. Mark Greveling corresponding

   University Medical Center Utrecht

   Affiliation as printed

   Department of Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands

   Department of Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands m.j.greveling@umcutrecht.nl

2. Voon Hong Ong

   University College London

   Affiliation as printed

   Department of Medicine, Department of Inflammation, Centre for Rheumatology and Connective Tissue Diseases, University College London, London, UK

3. Christopher P. Denton

   University College London

   Affiliation as printed

   Department of Medicine, Department of Inflammation, Centre for Rheumatology and Connective Tissue Diseases, University College London, London, UK

4. Wouter Foppen

   University Medical Center Utrecht

   Affiliation as printed

   Department of Radiology and Nuclear Medicine, UMC Utrecht, Utrecht, The Netherlands

5. Amin Herman

   St. Antonius Ziekenhuis

   Affiliation as printed

   Department of Rheumatology, St Antonius Hospital, Nieuwegein, The Netherlands

6. Nick Jeffries-Owen
   Affiliation as printed

   SRUK, London, UK

7. Marion C Kortekaas Aachen Department of Rheumatology, Leids Universitair Medisch Centrum

   Leiden University Medical Center · Flevoziekenhuis

   Affiliation as printed

   Department of Rheumatology, Flevoziekenhuis, Almere, The Netherlands

   Department of Rheumatology, Leids Universitair Medisch Centrum, Leiden, The Netherlands

8. I. S. Masselink

   University Medical Center Utrecht

   Affiliation as printed

   Department of Revalidation, UMC Utrecht, Utrecht, The Netherlands

9. Douwe Johannes Mulder

   University Medical Center Groningen · University of Groningen

   Affiliation as printed

   Department of Internal Medicine, Division of Vascular Medicine, UMCG, Groningen, The Netherlands

10. Rita Schriemer
    Affiliation as printed

    Dutch Patient Organization for Systemic Autoimmune Diseases, NVLE, Utrecht, The Netherlands

11. Madelon C Vonk

    Radboud University Medical Center

    Affiliation as printed

    Department of Rheumatology, Radboudumc, Nijmegen, The Netherlands

12. Jeska Kirsten De Vries-Bouwstra Aachen Department of Rheumatology, Leids Universitair Medisch Centrum

    Leiden University Medical Center

    Affiliation as printed

    Department of Rheumatology, Leids Universitair Medisch Centrum, Leiden, The Netherlands

13. Paco M J Welsing

    University Medical Center Utrecht

    Affiliation as printed

    Department of Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands

14. S.C. Mastbergen

    University Medical Center Utrecht

    Affiliation as printed

    Department of Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands

15. Julia Spierings

    University Medical Center Utrecht · University College London

    Affiliation as printed

    Department of Medicine, Department of Inflammation, Centre for Rheumatology and Connective Tissue Diseases, University College London, London, UK

    Department of Rheumatology and Clinical Immunology, UMC Utrecht, Utrecht, The Netherlands