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Connective tissue diseases (CTD) or systemic autoimmune diseases (SADs) as they are known today are a group of chronic inflammatory conditions with autoimmune aetiology with few treatment options and difficult diagnosis.Brest team contribute to perform a new classification of the following systemic autoimmune diseases in a European Union's Seventh Framework Programme. The aim of this research is to reclassify the individuals affected by SADs into molecular clusters instead of clinical entities through the determination of molecular profiles using several "Omics" techniques.
Full description
The main objective of the PRECISESADS project is to reclassify the individuals affected by SADs into molecular clusters instead of clinical entities through the determination of molecular profiles using several "-omics" techniques.
The specific objectives of this cross sectional study and sub-study are:
The clustering process will be data-driven with the aim to find the most homogenous and differentiated clusters of diseases that clearly separate individuals on the basis of, serological, genetic, epigenomic, cellular (cell proportions), metabolomic, proteomic (cytokines, autoantibodies) and transcriptome characteristics and differentiate them from controls and other patient clusters.
A total of 2000 patients and 666 controls will be included in the study, adjusted to the following distribution:
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Inclusion criteria
· Aged 18 years or older at the time of consent
Diagnosed according to prevailing criteria for one of the following systemic autoimmune diseases (see Annex 2)
Signed the informed consent form
Exclusion criteria
· Patients unable to understand the procedures related to the protocol should not be included. The study is voluntary and patients must be able to give their informed consent.
Pregnant women
Neonatal lupus
Drug-induced lupus
Patients whose condition is so serious that they cannot take part in the study
Severe nephrotic syndrome with proteinuria >=3,5 g/day
Patients with stable doses of steroids >15mg/day for the last 3 months or with IV corticosteroids in the last 3 months
Patients under immunosuppressants for the last 3 months prior to recruitment with:
Treatment with cyclophosphamide (any dose or route of administration) or Belimumab in the past 6 months
Patients with combined therapy of two or more immunosuppressants
Patients on depletive therapy such as Rituximab in the last year
Patients receiving experimental therapy.
Chronic HBV or HCV infection
Overlap syndromes
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Data sourced from clinicaltrials.gov
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