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

Psoriatic Arthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03214263
• Other study ID #: REUM BIOMARKØRER 2014-10-30
• Status: Recruiting
• Start date: May 2015
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Rigshospitalet, Denmark
• Contact: Merete L Hetland, Professor, MD, DMSc, PhD
• Phone: 0045-38633330
• Email: merete.hetland[@]dadlnet.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Axial Spondyloarthritis
• Collagen Diseases
• Connective Tissue Diseases
• Gout
• Psoriatic Arthritis
• Rheumatic Diseases
• Spondylarthritis
• Spondylitis

Locations

Country	Name	City	State
Denmark	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	Danish Arthritis Hospital	Sønderborg
Denmark	Department of Rheumatology, Svendborg Hospital	Svendborg
Denmark	Department of Rheumatology, Hospital Lillebaelt	Vejle

Sponsors (13)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aalborg University Hospital, Aarhus University Hospital, Copenhagen University Hospital at Herlev, Hillerod Hospital, Denmark, King Christian X´Hospital for Rheumatic Diseases, Odense University Hospital, Randers Regional Hospital, Svendborg Hospital, Sygehus Lillebaelt, University Hospital Bispebjerg and Frederiksberg, University Hospital, Gentofte, Copenhagen, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External Links

•   Bio- and GenomeBank Denmark and Danish Rheumatologic Biobank
•   DANBIO