Clinical trial NCT03214263: Identification of New Biomarkers to Promote Personalized Treatment of Patients With Inflammatory Rheumatic Diseases
Official title: Identification of New Biomarkers to Improve Diagnostics or Predict Treatment Responses, Adverse Events or Prognosis in Patients With Inflammatory Rheumatic Disease Followed in the Danish Nationwide Quality Registry, DANBIO
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arthritis, Rheumatoid
Psoriatic Arthritis
Axial Spondyloarthritis
Connective Tissue Diseases
Gout
Keywords: Inflammatory rheumatic diseases
Biomarkers
Tailored treatment
Personalised medicine
DANBIO
Danish Rheumatologic Biobank
clinical data
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
name: Copenhagen University Hospital at Herlev
name: King Christian X´Hospital for Rheumatic Diseases
name: Svendborg Hospital
name: Zealand University Hospital
name: Aalborg University Hospital
name: Aarhus University Hospital
name: Sygehus Lillebaelt
name: Odense University Hospital
name: Hillerod Hospital, Denmark
name: Randers Regional Hospital
name: University Hospital Bispebjerg and Frederiksberg
First posted: 2017-07-11
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are eligible for inclusion if they are followed in routine care and monitored in DANBIO with one of the following diagnoses: RA, axSpA (including ankylosing spondylitis), PsA, other inflammatory rheumatic diseases, connective tissue disorders or gout, or are suspected for one of the above. Patients must be able to give written informed consent and aged ≥18 years.

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.


Eligibility criteria: 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

Primary outcomes:
measure: To diagnose inflammatory rheumatic diseases early in the disease course with high specificity and sensitivity
timeFrame: Changes from baseline to 3, 6, 12, 24, 36, 48, and 60 months
measure: To improve prognostication
timeFrame: At diagnosis and after 3, 6, 12, 24, 36, 48 and 60 months
measure: To predict treatment effectiveness and tolerability for the individual patient
timeFrame: At treatment onset and at 3, 6, 12, 24, 36, 48 and 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Rheumatology, Aalborg University Hospital
city: Aarhus
country: Denmark
facility: Department of Rheumatology, Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Department of Rheumatology, Rigshospitalet
city: Copenhagen
country: Denmark
facility: Dept. of Rheumaology, University Hospital Bispebjerg and Frederiksberg
city: Hjørring
country: Denmark
facility: Dept. of Rheumaology, North Denmark Regional Hospital
city: Køge
country: Denmark
facility: Department of Rheumatology, Zealand University Hospital Køge
city: Odense
country: Denmark
facility: Department of Rheumatology, Odense University Hospital
city: Randers
country: Denmark
facility: Dept. of Rheumaology, Randers Regional Hospital
city: Svendborg
country: Denmark
facility: Department of Rheumatology, Svendborg Hospital
city: Sønderborg
country: Denmark
facility: Danish Arthritis Hospital
city: Vejle
country: Denmark
facility: Department of Rheumatology, Hospital Lillebaelt
Study officials:
affiliation: Rigshospitalet, Glostrup, Denmark
name: Merete L Hetland, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kringelbach TM, Glintborg B, Hogdall EV, Johansen JS, Hetland ML; Biomarker Protocol Study Group. Identification of new biomarkers to promote personalised treatment of patients with inflammatory rheumatic disease: protocol for an open cohort study. BMJ Open. 2018 Feb 1;8(2):e019325. doi: 10.1136/bmjopen-2017-019325.