Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies

Systemic Sclerosis Clinical Trial

— SCLERONAB  

Official title:

Phenotypic Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06412614
• Other study ID #: 2024PI015
• Status: Not yet recruiting
• Start date: September 2, 2024
• Est. completion date: June 29, 2025

Study information

• Verified date: May 2024
• Source: Central Hospital, Nancy, France
• Contact: Paul Decker, MD
• Phone: +33383157240
• Email: p.decker[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: June 29, 2025
• Est. primary completion date: June 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Other:
• disease phenotype
evaluation of SSc phenotypes

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHU Brest	Brest
France	CH Dunkerque	Dunkerque
France	CHU Grenoble	Grenoble
France	CHU Lille	Lille
France	Hospices Civils de Lyon	Lyon
France	AP-HM	Marseille
France	CHU Nice	Nice
France	APHP	Paris
France	CHU Poitiers	Poitiers
France	CHU Reims	Reims
France	CHU Rennes	Rennes
France	Hôpitaux Universitaires de Strasbourg	Strasbourg
France	Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnosis time	duration between date of first symptom (excluding Raynaud's phenomenon) and SSc diagnosis	baseline (J0)
Secondary	number of patients with scleroderma	sine scleroderma (no scleroderma), limited scleroderma or diffuse scleroderma	baseline (J0)
Secondary	number of patients with raynaud's phenomenon		baseline (J0)
Secondary	number of patients with digital ulcers		baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
Secondary	number of patients with calcinosis		baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
Secondary	number of patients with telangiectases		baseline (J0)
Secondary	number of patients with articular involvement		baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
Secondary	number of patients with muscular involvement		baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
Secondary	number of patients with cardiac involvement		baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
Secondary	number of patients with interstitial lung disease		baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
Secondary	number of patients with pulmonary arterial hypertension		baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
Secondary	number of patients with scleroderma renal crisis		baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
Secondary	number of patients with gastrointestinal involvement		baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
Secondary	modified Rodnan skin score		baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
Secondary	forced vital capacity (FVC)	%predicted FVC values	baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
Secondary	diffusing capacity for carbon monoxide (DLCO)	%predicted DLCO values	baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)
Secondary	rate of patients without death		3 years and 5 years of follow-up