Systemic SclerosisSCLERONABNCT06412614
Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies
An observational study of Systemic Sclerosis, run by Central Hospital, Nancy, France at 14 sites in France.
Trial summary
Systemic sclerosis (SSc) is a complex systemic autoimmune disease with variable phenotype and prognosis. Autoantibodies are important diagnostic biomarkers in SSc. More than 90% of patients with SSc had anti-nuclear antibodies. 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?
- disease phenotype
- How many people
- 300 participants
- Where
- 14 sitesFrance
- Study dates
- 2 Sep 2024to 29 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 followed in internal medicine or rheumatology units until December 2021
Who may be able to join
- Patient with systemic sclerosis defined according to ACR/EULAR 2013 classification criteria
- Patient with a minimum follow-up of 3 years since the diagnosis of systemic sclerosis
- Patient evaluated for the following systemic sclerosis specific and/or associated autoantibodies: anti-topoisomerase I, anti-centromere, anti-RNA polymerase III (RP155 and RP11), anti-Th/To antibodies , anti-fibrillarin, anti-NOR90, anti-PM/Scl, anti-KU, anti-U1RNP and anti-SSA antibodies (independently of antinuclear antibodies status)
Who cannot join
- Patient with equivocal results for one or more systemic sclerosis specific and/or associated autoantibodies
- Patient initially negative but with a positive result for systemic sclerosis specific and/or associated autoantibodies during follow-up
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
CHU Angers
Angers
Christian Lavigne
CHU Brest
Brest
Claire De Moreuil
CH Dunkerque
Dunkirk
Amélie Leurs
CHU Grenoble
Grenoble
Alban Deroux
CHU Lille
Lille
David Launay
Hospices Civils de Lyon
Lyon
Claire Grange
AP-HM
Marseille
Brigitte Granel
CHU Nice
Nice
Viviane Queyrel
APHP
Paris
Benjamin Chaigne
CHU Poitiers
Poitiers
Mickaël Martin
CHU Reims
Reims
Amélie Servettaz
CHU Rennes
Rennes
Alain Lescoat
Hôpitaux Universitaires de Strasbourg
Strasbourg
Hôpitaux Universitaires de Strasbourg
Strasbourg
Emmanuel Chatelus
About this study
Official title: Phenotypic Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies
Systemic sclerosis (SSc) is a complex systemic autoimmune disease with variable phenotype and prognosis. Autoantibodies are important diagnostic biomarkers in SSc. More than 90% of patients with SSc had anti-nuclear antibodies. Autoantibodies specific to SSc (anti-topoisomerase I antibodies, anti-centromeres, anti-RNA polymerase III, anti-Th/To, anti-fibrillarin, anti-NOR90) or associated with overlap syndromes (anti-RNA polymerase III antibodies -PM/Scl, anti-KU, anti-U1RNP, anti-TRIM21) are detected in most patients. Excluding anti-TRIM21 antibodies, autoantibodies are usually mutually exclusive and are associated with distinct phenotypes.
Around 5 to 10% of patients with SSc have no autoantibodies detectable with routine biological tests. Recently, new autoantibody specificities have been described in SSc (anti-eIF2B, anti-RuvBL1/2, anti-BICD2, anti-U11/U12 RNP antibodies).
Read more
"Seronegative" patients could represent new specificities of autoantibodies (unknown or not currently routinely evaluated) associated with different phenotypes of the disease.
Primary objective is to compare the phenotype of patients with systemic sclerosis with or without detectable specific or associated autoantibodies.
Secondary objectives are:
- to determine homogeneous groups of patients with systemic sclerosis without detectable specific or associated autoantibodies
- to compare the phenotype of patients with systemic sclerosis without detectable specific or associated autoantibodies according to anti-nuclear antibodies status
- Conditions
- Systemic Sclerosis
- Being tested
- disease phenotype
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disease phenotypeOther
evaluation of SSc phenotypes
| Study group | Role | What they receive |
|---|---|---|
| SSc patients without specific or associated autoantibodies ("seronegative" patients) | Not described Receives: Other: disease phenotype | |
| SSc patients with specific or associated autoantibodies | Not described Receives: Other: disease phenotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis time
duration between date of first symptom (excluding Raynaud's phenomenon) and SSc diagnosis
Measured: baseline (J0)
Secondary outcomes (16)
number of patients with scleroderma
sine scleroderma (no scleroderma), limited scleroderma or diffuse scleroderma
Measured: baseline (J0)
number of patients with raynaud's phenomenon
Measured: baseline (J0)
number of patients with digital ulcers
Measured: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
number of patients with calcinosis
Measured: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
number of patients with telangiectases
Measured: baseline (J0)
number of patients with articular involvement
Measured: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
number of patients with muscular involvement
Measured: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
number of patients with cardiac involvement
Measured: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
number of patients with interstitial lung disease
Measured: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
number of patients with pulmonary arterial hypertension
Measured: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
number of patients with scleroderma renal crisis
Measured: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
number of patients with gastrointestinal involvement
Measured: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
modified Rodnan skin score
Measured: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
forced vital capacity (FVC)
%predicted FVC values
Measured: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
diffusing capacity for carbon monoxide (DLCO)
%predicted DLCO values
Measured: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
rate of patients without death
Measured: 3 years and 5 years of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start2 Sep 2024 (estimated)
- Primary completion29 Jun 2025 (estimated)
- Study completion29 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul DECKER, MD, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412614
- Sponsor's protocol ID
- 2024PI015
- Acronym
- SCLERONAB
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies
- ClinicalTrials.gov ID
- NCT06412614
- Acronym / sponsor ID
- SCLERONAB / 2024PI015
- Conditions
- Systemic Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 2 Sep 2024 (estimated)
- Primary completion
- 29 Jun 2025 (estimated)
- Study completion
- 29 Jun 2025 (estimated)
- First posted
- 14 May 2024 (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.
Systemic sclerosis (SSc) is a complex systemic autoimmune disease with variable phenotype and prognosis. Autoantibodies are important diagnostic biomarkers in SSc. More than 90% of patients with SSc had anti-nuclear antibodies. Autoantibodies specific to SSc (anti-topoisomerase I antibodies, anti-centromeres, anti-RNA polymerase III, anti-Th/To, anti-fibrillarin, anti-NOR90) or associated with overlap syndromes (anti-RNA polymerase III antibodies -PM/Scl, anti-KU, anti-U1RNP, anti-TRIM21) are detected in most patients. Excluding anti-TRIM21 antibodies, autoantibodies are usually mutually exclusive and are associated with distinct phenotypes.
Around 5 to 10% of patients with SSc have no autoantibodies detectable with routine biological tests. Recently, new autoantibody specificities have been described in SSc (anti-eIF2B, anti-RuvBL1/2, anti-BICD2, anti-U11/U12 RNP antibodies).
"Seronegative" patients could represent new specificities of autoantibodies (unknown or not currently routinely evaluated) associated with different phenotypes of the disease.
Primary objective is to compare the phenotype of patients with systemic sclerosis with or without detectable specific or associated autoantibodies.
Secondary objectives are:
- to determine homogeneous groups of patients with systemic sclerosis without detectable specific or associated autoantibodies
- to compare the phenotype of patients with systemic sclerosis without detectable specific or associated autoantibodies according to anti-nuclear antibodies status
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSc patients without specific or associated autoantibodies ("seronegative" patients) | – | Other: disease phenotype |
| SSc patients with specific or associated autoantibodies | – | Other: disease phenotype |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed in internal medicine or rheumatology units until December 2021
Key inclusion criteria (3 listed)
- Patient with systemic sclerosis defined according to ACR/EULAR 2013 classification criteria
- Patient with a minimum follow-up of 3 years since the diagnosis of systemic sclerosis
- Patient evaluated for the following systemic sclerosis specific and/or associated autoantibodies: anti-topoisomerase I, anti-centromere, anti-RNA polymerase III (RP155 and RP11), anti-Th/To antibodies , anti-fibrillarin, anti-NOR90, anti-PM/Scl, anti-KU, anti-U1RNP and anti-SSA antibodies (independently of antinuclear antibodies status)
Key exclusion criteria (2 listed)
- Patient with equivocal results for one or more systemic sclerosis specific and/or associated autoantibodies
- Patient initially negative but with a positive result for systemic sclerosis specific and/or associated autoantibodies during follow-up
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 |
|---|---|---|
| disease phenotypeevaluation of SSc phenotypes | Other | SSc patients with specific or associated autoantibodies, SSc patients without specific or associated autoantibodies ("seronegative" patients) |
Primary outcome
diagnosis time
Time frame: baseline (J0)
duration between date of first symptom (excluding Raynaud's phenomenon) and SSc diagnosis
16 secondary outcomes
number of patients with scleroderma
Time frame: baseline (J0)
number of patients with raynaud's phenomenon
Time frame: baseline (J0)
number of patients with digital ulcers
Time frame: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
number of patients with calcinosis
Time frame: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
number of patients with telangiectases
Time frame: baseline (J0)
number of patients with articular involvement
Time frame: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
number of patients with muscular involvement
Time frame: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
number of patients with cardiac involvement
Time frame: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
number of patients with interstitial lung disease
Time frame: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
number of patients with pulmonary arterial hypertension
Time frame: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
number of patients with scleroderma renal crisis
Time frame: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
number of patients with gastrointestinal involvement
Time frame: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
modified Rodnan skin score
Time frame: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
forced vital capacity (FVC)
Time frame: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
diffusing capacity for carbon monoxide (DLCO)
Time frame: baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
rate of patients without death
Time frame: 3 years and 5 years of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
Related trials for Systemic Sclerosis
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
RecruitingPhase 1/2
A Study of AZD0120 in Autoimmune Diseases
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
RecruitingPhase 1
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
Active, not recruitingObservational study
Cross-cultural Adaptation and Validation of the Localised Scleroderma Quality of Life Instrument (LoSQI) in Juvenile Localised Scleroderma (JLS)
Scleroderma
Active, not recruiting
Patient Reported Outcomes With UVA-1 Therapy for Treatment of Sclerosing Skin Diseases
Scleroderma, Systemic, Morphea
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. This study is not recruiting at the moment.
14 sites 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 Central Hospital, Nancy, France at 14 sites in France.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 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 14 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Decker, MD (+33383157240, p.decker@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnosis time (time frame: baseline (J0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2024.