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

January 8, 2024 updated by: Merete L Hetland, Rigshospitalet, Denmark

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

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Aalborg, Denmark
        • Recruiting
        • Department of Rheumatology, Aalborg University Hospital
      • Aarhus, Denmark
        • Recruiting
        • Department of Rheumatology, Aarhus University Hospital
      • Copenhagen, Denmark
        • Recruiting
        • Department of Rheumatology, Rigshospitalet
      • Copenhagen, Denmark
        • Recruiting
        • Dept. of Rheumaology, University Hospital Bispebjerg and Frederiksberg
      • Hjørring, Denmark
        • Recruiting
        • Dept. of Rheumaology, North Denmark Regional Hospital
      • Køge, Denmark
        • Recruiting
        • Department of Rheumatology, Zealand University Hospital Køge
      • Odense, Denmark
        • Recruiting
        • Department of Rheumatology, Odense University Hospital
      • Randers, Denmark
        • Recruiting
        • Dept. of Rheumaology, Randers Regional Hospital
      • Svendborg, Denmark
        • Recruiting
        • Department of Rheumatology, Svendborg Hospital
      • Sønderborg, Denmark
        • Recruiting
        • Danish Arthritis Hospital
      • Vejle, Denmark
        • Recruiting
        • Department of Rheumatology, Hospital Lillebaelt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To diagnose inflammatory rheumatic diseases early in the disease course with high specificity and sensitivity
Time Frame: 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
Changes from baseline to 3, 6, 12, 24, 36, 48, and 60 months
To improve prognostication
Time Frame: 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)
At diagnosis and after 3, 6, 12, 24, 36, 48 and 60 months
To predict treatment effectiveness and tolerability for the individual patient
Time Frame: 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
At treatment onset and at 3, 6, 12, 24, 36, 48 and 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

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

Investigators

  • Principal Investigator: Merete L Hetland, Professor, Rigshospitalet, Glostrup, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 6, 2017

First Submitted That Met QC Criteria

July 10, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REUM BIOMARKØRER 2014-10-30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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