Systemic SclerosisNCT06133244
Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME)
An observational study of Systemic Sclerosis, run by UMC Utrecht at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Imaging, blood samples, fuctional tests and physical examination
- How many people
- 300 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Apr 2024to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Age > 18 years
Who cannot join
- Patients with diabetic cheiroarthropathy and Dupuytren's disease, based on expert opinion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
UMC Utrecht
Utrecht
Julia Spierings, MD, 088 755 5555, handsome@umcutrecht.nl
About this study
Official title: 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.
- Conditions
- Systemic Sclerosis
- Being tested
- Imaging, blood samples, fuctional tests and physical examination
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging, blood samples, fuctional tests and physical examinationDiagnostic test
Imaging, blood samples, fuctional tests and physical examination
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Imaging, blood samples, fuctional tests and physical examination | |
| SSc with disease duration of < 4 years without hand contractures | Not described Receives: Diagnostic Test: Imaging, blood samples, fuctional tests and physical examination | |
| SSc with hand contractures | Not described Receives: Diagnostic Test: Imaging, blood samples, fuctional tests and physical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (2)
Identify underlying mechanisms
Measured: 2 years
- Validation of the Dutch PASTUL questionnaire
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start19 Apr 2024
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen, Radboud University Medical Center, Leiden University Medical Center, Royal Free Hospital NHS Foundation Trust
- Responsible party
- Principal investigator, Julia Spierings, MD PhD, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133244
- Sponsor's protocol ID
- NL85445.041.23
- Status last verified
- May 2024
- First submitted
- 10 Nov 2023
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40082008
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Function Impairment in Systemic Sclerosis: Outcomes, Mechanisms and Experience (HANDSOME) Study
- ClinicalTrials.gov ID
- NCT06133244
- Acronym / sponsor ID
- NL85445.041.23
- Conditions
- Systemic Sclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, Radboud University Medical Center, Leiden University Medical Center, Royal Free Hospital NHS Foundation Trust
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VEDOSS | – | Diagnostic Test: Imaging, blood samples, fuctional tests and physical examinationdefined 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 | – | Diagnostic Test: Imaging, blood samples, fuctional tests and physical examination |
| SSc with hand contractures | – | Diagnostic Test: Imaging, blood samples, fuctional tests and physical examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Age > 18 years
Key exclusion criteria (1 listed)
- Patients with diabetic cheiroarthropathy and Dupuytren's disease, based on expert opinion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging, blood samples, fuctional tests and physical examinationImaging, blood samples, fuctional tests and physical examination | Diagnostic test | SSc with disease duration of < 4 years without hand contractures, SSc with hand contractures, VEDOSS |
Primary outcome
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
Time frame: 2 years
2 secondary outcomes
Identify underlying mechanisms
Time frame: 2 years
- Validation of the Dutch PASTUL questionnaire
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Derived from this study: PubMed 40082008Greveling 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06133244, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.