Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies

Launched by CENTRAL HOSPITAL, NANCY, FRANCE · May 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying systemic sclerosis (SSc), a disease where the body's immune system mistakenly attacks its own tissues, leading to thickening and hardening of the skin and other organs. The focus is on understanding how SSc affects patients who do not have detectable autoantibodies, which are proteins that can indicate the presence of autoimmune diseases. While most SSc patients test positive for specific autoantibodies, about 5 to 10% do not show these markers. This trial aims to explore the characteristics of these "seronegative" patients to see if they have different disease features compared to those with detectable autoantibodies.

To be eligible for this trial, participants must have a confirmed diagnosis of systemic sclerosis and have been living with the disease for at least three years. They will need to have been tested for several specific autoantibodies related to SSc. Those whose test results are unclear or who later test positive for autoantibodies during the study will not be included. Participants can expect to undergo assessments that will help researchers categorize different patient groups and understand how the disease may vary among them. This study will contribute to better insights into systemic sclerosis and could lead to improved care for patients.

Gender

ALL

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