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.
Study Type
OBSERVATIONAL
Enrollment
20,000
Department of Rheumatology, Aalborg University Hospital
Aalborg, Denmark
RECRUITINGDepartment of Rheumatology, Aarhus University Hospital
Aarhus, Denmark
RECRUITINGDepartment of Rheumatology, Rigshospitalet
Copenhagen, Denmark
RECRUITINGDept. of Rheumaology, University Hospital Bispebjerg and Frederiksberg
Copenhagen, Denmark
RECRUITINGDept. of Rheumaology, North Denmark Regional Hospital
Hjørring, Denmark
RECRUITINGDepartment of Rheumatology, Zealand University Hospital Køge
Køge, Denmark
RECRUITINGDepartment of Rheumatology, Odense University Hospital
Odense, Denmark
RECRUITINGDept. of Rheumaology, Randers Regional Hospital
Randers, Denmark
RECRUITINGDepartment of Rheumatology, Svendborg Hospital
Svendborg, Denmark
RECRUITINGDanish Arthritis Hospital
Sønderborg, Denmark
RECRUITING...and 1 more locations
To diagnose inflammatory rheumatic diseases early in the disease course with high specificity and sensitivity
Number of patients suspected of rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, gout or connective tissue diseases that can be correctly diagnosed
Time frame: Changes from baseline to 3, 6, 12, 24, 36, 48, and 60 months
To improve prognostication
Number of patients that can be correctly prognosticated by progression in physical function (by HAQ) and in bone damage (by imaging)
Time frame: At diagnosis and after 3, 6, 12, 24, 36, 48 and 60 months
To predict treatment effectiveness and tolerability for the individual patient
Number of patients that achieve a standardized treatment response and do not experience serious adverse events
Time frame: At treatment onset and at 3, 6, 12, 24, 36, 48 and 60 months
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