Molecular Reclassification to Find Clinically Useful Biomarkers for Systemic Autoimmune Diseases: Inception Cohort
NCT ID: NCT02890134
Last Updated: 2021-10-15
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
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COMPLETED
215 participants
OBSERVATIONAL
2015-06-30
2018-07-31
Brief Summary
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Detailed Description
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The identification of the clusters relies on a cross sectional (CS) cohort/protocol where 2666 individuals (2000 patients and 666 controls) including a sub-study of 288 deeply characterized individuals (240 patients and 48 controls) are to be recruited.
In parallel a longitudinal inception cohort/protocol will be started in order to further explore the clinical relevance of the identified clusters and their evolution over time.
The objectives of the CS 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 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. A deeper analysis will be done 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 differentiate individuals from controls and other patient clusters.
Aims of the Inception cohort:
Specifically, this inception cohort aims at:
1. assign individuals newly diagnosed with an systemic autoimmune disease (SAD) to any of the reclassification clusters discovered in the CS study,
2. to study the development and modifications of OMICS signatures/clusters occurring in each individual patient in the course of the disease, including the impact of treatment on their individual pattern, and
3. to perform deep (thorough) OMICs studies to compare their patterns of OMICS as a group, with the patterns obtained in the CS cohort.
The inception cohort will have patient follow up and sample collection at baseline, month 6(±1 month) and month 18 (±1 month).
As the newly diagnosed patients we plan to recruit will have minimum or no treatment, we will identify differences and similitudes to patients from the cross-sectional study that have undergone long-term treatment.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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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 depletative therapy such as Rituximab in the last year
* Patients receiving experimental
* Overlap syndromes
18 Years
ALL
No
Sponsors
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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
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Principal Investigators
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Marta Alarcon
Role: STUDY_DIRECTOR
Fundación Pública Andaluza Progreso y Salud (PHFSpain)
Locations
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Université catholique de Louvain - Cliniques Universitaires Saint-Luc (UCL)
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
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico (IRCCS)
Milan, , Italy
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
Hospitaux Universitaires de Géneve (UNIGE)
Geneva, , Switzerland
Countries
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Other Identifiers
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PRECISESADS INCP (RB 15.007)
Identifier Type: -
Identifier Source: org_study_id