Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies

NCT06412614 | Not Yet Recruiting

• 1 other identifier: 2024PI015
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 14

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

Outcome Measures

Primary Outcomes (1)

• diagnosis time

  duration between date of first symptom (excluding Raynaud's phenomenon) and SSc diagnosis

  baseline (J0)

Secondary Outcomes (16)

• number of patients with scleroderma

  baseline (J0)

• number of patients with raynaud's phenomenon

  baseline (J0)

• number of patients with digital ulcers

  baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)

• number of patients with calcinosis

  baseline (J0), 3 years of follow-up and through study completion (an average of 5 years)

• number of patients with telangiectases

  baseline (J0)

Study Arms (2)

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

Other: disease phenotype

SSc patients with specific or associated autoantibodies

Other: disease phenotype

Interventions

disease phenotype OTHER

evaluation of SSc phenotypes

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients followed in internal medicine or rheumatology units until December 2021

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (14)

CHU Angers

Angers, France

Location

CHU Brest

Brest, France

Location

CH Dunkerque

Dunkirk, France

Location

CHU Grenoble

Grenoble, France

Location

CHU Lille

Lille, France

Location

Hospices Civils de Lyon

Lyon, France

Location

AP-HM

Marseille, France

Location

CHU Nice

Nice, France

Location

APHP

Paris, France

Location

CHU Poitiers

Poitiers, France

Location

CHU Reims

Reims, France

Location

CHU Rennes

Rennes, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Paul Decker, MD

CONTACT

+33383157240; p.decker@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 14, 2024
• Study Start: September 2, 2024
• Primary Completion: June 29, 2025
• Study Completion: June 29, 2025
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14)