Arthritis, Rheumatoid, Axial Spondyloarthritis, Connective Tissue Diseases, Gout, Psoriatic Arthritis
Conditions
Keywords
Inflammatory rheumatic diseases, Biomarkers, Tailored treatment, Personalised medicine, DANBIO, Danish Rheumatologic Biobank, clinical data
Brief summary
Introduction: The medical treatment of inflammatory rheumatic diseases has improved dramatically during the last decades primarily due to the introduction of biological disease modifying anti-rheumatic drugs (bDMARDs). However, bDMARD treatment failure occurs in 30-40% of patients due to lack of effectiveness or side effects. The tools to predict treatment outcomes in the individual patient are currently limited. The objective of the present study is to identify diagnostic, prognostic and predictive biomarkers, which can be used to 1) diagnose inflammatory rheumatic diseases early in the disease course with high specificity and sensitivity, 2) improve prognostication or 3) predict treatment effectiveness and tolerability for the individual patient. Methods and analysis: Observational and translational open cohort study with prospective collection of clinical data and biological materials in patients with inflammatory rheumatic diseases treated in routine care. Patients contribute one cross-sectional blood sample (i.e. whole blood, serum, EDTA-plasma and -buffy coat, and blood in PAXgene RNA tubes) and/or are enrolled for longitudinal follow-up upon start of new DMARD (blood sampling after 0/3/6/12/24/36/48/60 months' treatment). Demographics, disease characteristics, comorbidities and lifestyle factors are registered at inclusion; DMARD treatment and outcomes are collected repeatedly during follow-up. Currently (June 2017) \>5,000 samples from ≈3,000 patients have been collected. Data will be analysed using appropriate statistical analyses. Ethics and dissemination: The protocol is approved by the Danish Ethics Committee and The Danish Data Protection Agency. All participants give written informed consent. Biomarkers will be evaluated and published according to REMARK, STROBE and STARD guidelines. Results will be published in peer-reviewed medical journals and presented at international conferences.
Interventions
None listed
Sponsors
University Hospital, Gentofte, Copenhagen
Copenhagen University Hospital at Herlev
King Christian X´Hospital for Rheumatic Diseases
Svendborg Hospital
Zealand University Hospital
Aalborg University Hospital
Aarhus University Hospital
Sygehus Lillebaelt
Odense University Hospital
Hillerod Hospital, Denmark
Randers Regional Hospital
University Hospital Bispebjerg and Frederiksberg
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with or suspected for the following diseases: rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (axSpA) or other inflammatory rheumatic diseases, connective tissue disorders or gout * Aged 18 year or older * Able to give informed consent
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To diagnose inflammatory rheumatic diseases early in the disease course with high specificity and sensitivity | Changes from baseline to 3, 6, 12, 24, 36, 48, and 60 months | Number of patients suspected of rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, gout or connective tissue diseases that can be correctly diagnosed |
| To improve prognostication | At diagnosis and after 3, 6, 12, 24, 36, 48 and 60 months | Number of patients that can be correctly prognosticated by progression in physical function (by HAQ) and in bone damage (by imaging) |
| To predict treatment effectiveness and tolerability for the individual patient | At treatment onset and at 3, 6, 12, 24, 36, 48 and 60 months | Number of patients that achieve a standardized treatment response and do not experience serious adverse events |
Countries
Denmark
Contacts
Primary ContactMerete L Hetland, Professor, MD, DMSc, PhD
Outcome results
None listed