Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME)

Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME) Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Sclerosis
• Intervention / Treatment: Diagnostic test: Imaging, blood samples, fuctional tests and physical examination

• Study Type: Observational
• Enrollment (Estimated): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Age > 18 years

Exclusion Criteria:

• Patients with diabetic cheiroarthropathy and Dupuytren's disease, based on expert opinion

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Diagnostic test: Imaging, blood samples, fuctional tests and physical examination; Imaging, blood samples, fuctional tests and physical examination
SSc with disease duration of < 4 years without hand contractures	Diagnostic test: Imaging, blood samples, fuctional tests and physical examination; Imaging, blood samples, fuctional tests and physical examination
SSc with hand contractures	Diagnostic test: Imaging, blood samples, fuctional tests and physical examination; Imaging, blood samples, fuctional tests and physical examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Identify underlying mechanisms	2 years
- Validation of the Dutch PASTUL questionnaire	2 years

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Collaborators: Radboud University Medical Center; University Medical Center Groningen; Royal Free Hospital NHS Foundation Trust; Leiden University Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: November 10, 2023
• First Submitted That Met QC Criteria: November 10, 2023
• First Posted (Actual): November 15, 2023

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Connective Tissue Diseases; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: NL85445.041.23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No