Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME)
1 other identifier
observational
300
1 country
1
Brief Summary
Almost 90% of systemic sclerosis (SSc) patients experience hand function limitation, which leads to impaired daily functioning and work participation. An important cause of impaired hand function are contractures of the hand, which are reported in up to a half of patients. With this longitudinal cohort study in patients with SSc and VEDOSS (very early diagnosis of systemic sclerosis) the investigators aim to gain more insight into processes involved in hand function impairment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2023
CompletedFirst Posted
Study publicly available on registry
November 15, 2023
CompletedStudy Start
First participant enrolled
April 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
May 28, 2024
May 1, 2024
4 years
November 10, 2023
May 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Determination of risk factors for hand function impairment in systemic sclerosis (SSc) patients with early disease, very early disease and established hand impairment (contractures) at 2 years follow-up
2 years
Secondary Outcomes (2)
Identify underlying mechanisms
2 years
- Validation of the Dutch PASTUL questionnaire
2 years
Study Arms (3)
VEDOSS
defined as RP, presence of SSc specific autoantibodies (ACA, ATA, ARA), puffy fingers and abnormal nailfold capillaroscopy (giant capillaries or capillary loss with or without haemorrhages), but not fulfilling the EULAR-ACR 2013 classification criteria for SSc
SSc with disease duration of < 4 years without hand contractures
SSc with hand contractures
Interventions
Imaging, blood samples, fuctional tests and physical examination
Eligibility Criteria
Patients (18 years and older) with: 1. SSc with hand contractures 2. SSc patients without contractures and disease duration of \< 4 years 3. VEDOSS patients
You may qualify if:
- Age \> 18 years
You may not qualify if:
- Patients with diabetic cheiroarthropathy and Dupuytren's disease, based on expert opinion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
- University Medical Center Groningencollaborator
- Radboud University Medical Centercollaborator
- Leiden University Medical Centercollaborator
- Royal Free Hospital NHS Foundation Trustcollaborator
Study Sites (1)
UMC Utrecht
Utrecht, Netherlands
Related Publications (1)
Greveling M, Ong VH, Denton C, Foppen W, Herman A, Jeffries-Owen N, Kortekaas M, Masselink I, Mulder DJ, Schriemer R, Vonk MC, de Vries-Bouwstra JK, Welsing P, Mastbergen S, Spierings J. Hand function impairment in Systemic sclerosis: Outcomes, Mechanisms and Experience (HANDSOME) - a longitudinal observational multicentre study protocol. BMJ Open. 2025 Mar 13;15(3):e095283. doi: 10.1136/bmjopen-2024-095283.
PMID: 40082008DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
November 10, 2023
First Posted
November 15, 2023
Study Start
April 19, 2024
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
May 28, 2024
Record last verified: 2024-05