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

• Sponsor: UMC Utrecht (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06133244
• Collaborator: University Medical Center Groningen (Other), Radboud University Medical Center (Other), Leiden University Medical Center (Other), Royal Free Hospital NHS Foundation Trust (Other)
• Enrollment: 300
• Anticipated Duration (Months): 48

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Sclerosis	Diagnostic Test: Imaging, blood samples, fuctional tests and physical examination

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official Title: Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME) Study
• Anticipated Study Start Date: Jan 1, 2024
• Anticipated Primary Completion Date: Jan 1, 2028
• Anticipated Study Completion Date: Jan 1, 2028

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Identify underlying mechanisms [2 years]

2. - Validation of the Dutch PASTUL questionnaire [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age > 18 years

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• UMC Utrecht
• University Medical Center Groningen
• Radboud University Medical Center
• Leiden University Medical Center
• Royal Free Hospital NHS Foundation Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Julia Spierings, MD PhD, Dr., UMC Utrecht
• ClinicalTrials.gov Identifier: NCT06133244
• Other Study ID Numbers: NL85445.041.23
• First Posted: Nov 15, 2023
• Last Update Posted: Nov 18, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Sclerosis

Study Results

No Results Posted as of Nov 18, 2023