Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies

NCT ID: NCT06412614

Last Updated: 2024-05-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-02
• Study Completion Date: 2025-06-29

Brief 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

Conditions

Systemic Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

SSc patients without specific or associated autoantibodies ("seronegative" patients)

disease phenotype

Intervention Type: OTHER

evaluation of SSc phenotypes

SSc patients with specific or associated autoantibodies

disease phenotype

Intervention Type: OTHER

evaluation of SSc phenotypes

Interventions

disease phenotype

evaluation of SSc phenotypes

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Paul DECKER, MD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHU Angers

Angers, , France

CHU Brest

Brest, , France

CH Dunkerque

Dunkirk, , 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, , France

Countries

France

Central Contacts

Paul Decker, MD

Role: CONTACT

p.decker@chru-nancy.fr

+33383157240

Facility Contacts

Christian Lavigne

Role: primary

Claire De Moreuil

Role: primary

Amélie Leurs

Role: primary

Alban Deroux

Role: primary

David Launay

Role: primary

Claire Grange

Role: primary

Brigitte Granel

Role: primary

Viviane Queyrel

Role: primary

Benjamin Chaigne

Role: primary

Mickaël Martin

Role: primary

Amélie Servettaz

Role: primary

Alain Lescoat

Role: primary

Emmanuel Chatelus

Role: primary

Other Identifiers

2024PI015

Identifier Type: -

Identifier Source: org_study_id