Identification of New Biomarkers to Promote Personalized Treatment of Patients With Inflammatory Rheumatic Diseases

Recruiting

• Conditions: Arthritis, Rheumatoid; Axial Spondyloarthritis; Gout; Psoriatic Arthritis; Connective Tissue Diseases

• Registration Number: NCT03214263
• Lead Sponsor: Rigshospitalet, Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-10
• Study First Posted: 2017-07-11
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-09
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (11)

Department of Rheumatology, Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Department of Rheumatology, Zealand University Hospital Køge; 🇩🇰 Køge, Denmark

Dept. of Rheumaology, North Denmark Regional Hospital; 🇩🇰 Hjørring, Denmark

Department of Rheumatology, Hospital Lillebaelt; 🇩🇰 Vejle, Denmark

Dept. of Rheumaology, University Hospital Bispebjerg and Frederiksberg; 🇩🇰 Copenhagen, Denmark

Department of Rheumatology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Department of Rheumatology, Svendborg Hospital; 🇩🇰 Svendborg, Denmark

Danish Arthritis Hospital; 🇩🇰 Sønderborg, Denmark

Department of Rheumatology, Odense University Hospital; 🇩🇰 Odense, Denmark

Dept. of Rheumaology, Randers Regional Hospital; 🇩🇰 Randers, Denmark

Department of Rheumatology, Rigshospitalet; 🇩🇰 Copenhagen, Denmark