Identification of New Biomarkers to Promote Personalized Treatment of Patients With Inflammatory Rheumatic Diseases
1 other identifier
observational
20,000
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2015
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 6, 2017
CompletedFirst Posted
Study publicly available on registry
July 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJanuary 9, 2024
January 1, 2024
9.6 years
July 6, 2017
January 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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)
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
At treatment onset and at 3, 6, 12, 24, 36, 48 and 60 months
Study Arms (3)
Cross-sectional samples:
Any patient followed in the DANBIO registry may be invited to participate when they meet for a scheduled routine clinical visit. These patients provide one cross-sectional blood sample.
Longitudinal samples:
Any patient followed in the DANBIO registry will be invited to participate when they start treatment with a new DMARD. Switching from csDMARD to bDMARD, or from one bDMARD to another bDMARD indicates a new baseline.
Samples of other biological material:
Patients followed in the DANBIO registry may be invited to participate if scheduled for one of the following procedures: joint puncture with extraction of synovial fluid, surgery or tissue sampling involving synovia, cartilage, bone, bone-marrow or other tissues. Representative samples from the synovial fluid or relevant tissue are collected after routine diagnostic or therapeutic analyses have been done
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- University Hospital, Gentofte, Copenhagencollaborator
- Copenhagen University Hospital at Herlevcollaborator
- King Christian X´Hospital for Rheumatic Diseasescollaborator
- Svendborg Hospitalcollaborator
- Zealand University Hospitalcollaborator
- Aalborg University Hospitalcollaborator
- Aarhus University Hospitalcollaborator
- Sygehus Lillebaeltcollaborator
- Odense University Hospitalcollaborator
- Hillerod Hospital, Denmarkcollaborator
- Randers Regional Hospitalcollaborator
- University Hospital Bispebjerg and Frederiksbergcollaborator
Study Sites (11)
Department of Rheumatology, Aalborg University Hospital
Aalborg, Denmark
Department of Rheumatology, Aarhus University Hospital
Aarhus, Denmark
Department of Rheumatology, Rigshospitalet
Copenhagen, Denmark
Dept. of Rheumaology, University Hospital Bispebjerg and Frederiksberg
Copenhagen, Denmark
Dept. of Rheumaology, North Denmark Regional Hospital
Hjørring, Denmark
Department of Rheumatology, Zealand University Hospital Køge
Køge, Denmark
Department of Rheumatology, Odense University Hospital
Odense, Denmark
Dept. of Rheumaology, Randers Regional Hospital
Randers, Denmark
Department of Rheumatology, Svendborg Hospital
Svendborg, Denmark
Danish Arthritis Hospital
Sønderborg, Denmark
Department of Rheumatology, Hospital Lillebaelt
Vejle, Denmark
Related Publications (1)
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.
PMID: 29391382DERIVED
Related Links
Biospecimen
EDTA-whole blood, EDTA-plasma, EDTA-buffy coat, serum, synovial fluid, tissue, PAXgene RNA tubes
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Merete L Hetland, Professor
Rigshospitalet, Glostrup, Denmark
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 6, 2017
First Posted
July 11, 2017
Study Start
May 1, 2015
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
January 9, 2024
Record last verified: 2024-01