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Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases: Inception Cohort
Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases: Inception Cohort

NCT02890134

CompletedN/A

Sponsor: Fundación Pública Andaluza Progreso y Salud

Conditions: Systemic Autoimmune Diseases

Countries: Belgium, France, Germany, Italy, Spain, Switzerland

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 performe a new classification of the following systemic autoimmune diseases in a European Union's Seventh Framework Programme. The aim of this research consiteis to reclassify the individuals affected by SADs into molecular clusters instead of clinical entities through the determination of molecular profiles using several "Omics" techniques.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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)

    * Rheumatoid arthritis (RA)
    * Scleroderma or systemic sclerosis (SSc)
    * Primary Sjögren's syndrome (SjS)
    * Systemic lupus erythematosus (SLE)
    * Primary antiphospholipid syndrome (PAPS)
    * Mixed Connective Tissue Disease (MCTD)
    * Patients with undifferentiated connective tissue disease (UCTD) for over 1 year and that do not fulfill the diagnosis of any of the above diseases.
  * 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:

    * Methotrexate ≥25mg/week
    * Azathioprine ≥2.5mg/kg/day
    * Cyclosporine A \> 3mg/kg/day
    * Mycophenolate Mofetil \> 2gr/day
  * 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 depletative therapy such as Rituximab in the last year
  * Patients receiving experimental
  * Overlap syndromes
Locations (10)
  • Brussels, Belgium
  • Leuven, Belgium
  • Brest, France
  • Berlin, Germany
  • Milan, Italy
  • Barcelona, Spain
  • Córdoba, Spain
  • Granada, Spain
  • Granada, Spain
  • Geneva, Switzerland