Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases:
NCT ID: NCT02890121
Last Updated: 2018-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
2006 participants
OBSERVATIONAL
2014-12-31
2017-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases: Inception Cohort
NCT02890134
Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases: Case-control
NCT02890147
Clinico-biological Collection to Investigate the Physiopathology of Systemic Autoimmune Diseases
NCT05251415
Prevalence and Seroconversion of COVID-19 in Autoimmune Diseases in Europe
NCT04397237
Biomarkers in Autoimmune Diseases, Vasculitis and Auto Inflammatory Diseases
NCT05383339
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The specific objectives of this cross sectional study and sub-study are:
1. To identify a systemic taxonomy for patients with SADs by producing the following data in individuals with SADs and controls: genetic, epigenomic, transcriptomic, flow cytometric (from peripheral blood mononuclear and polymorphonuclear cells (PBMCs)), metabolomics and proteomic in plasma and urine, exosome analysis, classical serology (antibodies and autoantibodies), and clinical data.
2. To better characterize individual SADs at the omics level.
3. To perform clustering analyses to determine the groups of individuals who, differentially from other groups, share specific molecular features (precision medicine).
4. To identify gene expression, methylation profiles through deconvolution methods comparing a mixture of cells with subpopulations determined by flow cytometry with separated cells, cytokine profiles and plasma metabolomics using Mass Spectrometry, in a substudy of 288 individuals.
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:
* A total of 400 patients diagnosed with systemic lupus erythematosus (SLE)
* A total of 400 patients diagnosed with rheumatoid arthritis (RA)
* A total of 400 patients diagnosed of scleroderma or systemic sclerosis (SSc)
* A total of 400 patients diagnosed of Sjögren's syndrome (SjS)
* A total of 400 patients diagnosed of primary antiphospholipid syndrome (PAPS) or Mixed Connective Tissue Disease (MCTD) or with undifferentiated disease • All patients will be recruited from 18 sites in Europe (Austria, Belgium, France, Germany, Italy, Portugal, Spain, Hungary and Switzerland).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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 depletive therapy such as Rituximab in the last year
* Patients receiving experimental therapy.
* Chronic HBV or HCV infection
* Overlap syndromes
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
UCB Biopharma S.P.R.L.
INDUSTRY
Atrys Health
INDUSTRY
National Research Council, Spain
OTHER_GOV
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Servicio Cántabro de Salud
OTHER
August Pi Sunyer Biomedical Research Institute
OTHER
Karolinska Institutet
OTHER
KU Leuven
OTHER
Klinikum der Universität Köln
OTHER
Hannover Medical School
OTHER
Medical University of Vienna
OTHER
Quartz Bio S.A.
OTHER
Andaluz Health Service
OTHER_GOV
The Cyprus Foundation for Muscular Dystrophy Research
OTHER
Universidad de Granada
OTHER
University of Milan
OTHER
Université Catholique de Louvain
OTHER
University Hospital, Brest
OTHER
University of Geneva, Switzerland
OTHER
Szeged University
OTHER
Bayer
INDUSTRY
Institut de Recherches Internationales Servier
OTHER
Sanofi
INDUSTRY
Eli Lilly and Company
INDUSTRY
Charite University, Berlin, Germany
OTHER
Centro Hospitalar do Porto
OTHER
Institut d'Investigació Biomèdica de Bellvitge
OTHER
Innovative Medicines Initiative
OTHER
Fundación Pública Andaluza Progreso y Salud
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marta Alarcon
Role: STUDY_DIRECTOR
Fundación Pública Andaluza Progreso y Salud (PHFSpain)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University of Vienna
Vienna, , Austria
Université catholique de Louvain - Cliniques Universitaires Saint-Luc
Brussels, , Belgium
UZ Leuven - KU Leuven, Department of Rheumatology (KU LEUVEN)
Leuven, , Belgium
CHRU de Brest
Brest, , France
Deutsches Rheuma-Forschungszentrum Berlin (DRFZ)
Berlin, , Germany
University of Cologne
Cologne, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
University of Szeged
Szeged, , Hungary
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico (IRCCS)
Milan, , Italy
UNIMI, Istituto Ortopedico Getano Pini
Milan, , Italy
Centro Hospitalar do Porto
Porto, , Portugal
Hospital Clinic I Provicia- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)
Barcelona, , Spain
Hospital Universitario Reina Sofía Andaluz de Salud
Córdoba, , Spain
Hospital Universitario San Cecilio Servicio Andaluz de Salud
Granada, , Spain
Hospital Virgen de las Nieves Granada
Granada, , Spain
Hospital Regional de Málaga Servicio Andaluz de Salud
Málaga, , Spain
Hospital Universitario Marqués de Valdecilla, Servicio Cántabro de Salud
Santander, , Spain
Hospitaux Universitaires de Géneve
Geneva, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRECISESADS CS (RB 14.106)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.