Arthritis, RheumatoidNCT03214263
Identification of New Biomarkers to Promote Personalized Treatment of Patients With Inflammatory Rheumatic Diseases
An observational study of Arthritis, Rheumatoid and Psoriatic Arthritis, run by Copenhagen University Hospital, Rigshospitalet at 11 sites in Denmark.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid, Psoriatic Arthritis, Axial Spondyloarthritis
- How many people
- 20,000 participants
- Where
- 11 sitesDenmark
- Study dates
- May 2015to Dec 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Denmark11 sites, 11 recruiting
- Recruiting
Department of Rheumatology, Aalborg University Hospital
Aalborg
- Recruiting
Department of Rheumatology, Aarhus University Hospital
Aarhus
- Recruiting
Department of Rheumatology, Rigshospitalet
Copenhagen
- Recruiting
Dept. of Rheumaology, University Hospital Bispebjerg and Frederiksberg
Copenhagen
- Recruiting
Dept. of Rheumaology, North Denmark Regional Hospital
Hjørring
- Recruiting
Department of Rheumatology, Zealand University Hospital Køge
Køge
- Recruiting
Department of Rheumatology, Odense University Hospital
Odense
- Recruiting
Dept. of Rheumaology, Randers Regional Hospital
Randers
- Recruiting
Danish Arthritis Hospital
Sønderborg
- Recruiting
Department of Rheumatology, Svendborg Hospital
Svendborg
- Recruiting
Department of Rheumatology, Hospital Lillebaelt
Vejle
About this study
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
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.
- 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
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Axial Spondyloarthritis, Connective Tissue Diseases, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: At treatment onset and at 3, 6, 12, 24, 36, 48 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study startMay 2015
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen, Copenhagen University Hospital at Herlev, King Christian X´Hospital for Rheumatic Diseases, Svendborg Hospital, Zealand University Hospital, Aalborg University Hospital, Aarhus University Hospital, Sygehus Lillebaelt, Odense University Hospital, Hillerod Hospital, Denmark, Randers Regional Hospital, University Hospital Bispebjerg and Frederiksberg
- Responsible party
- Principal investigator, Merete L Hetland, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Merete L Hetland, Professor, Principal investigator, Rigshospitalet, Glostrup, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03214263
- Sponsor's protocol ID
- REUM BIOMARKØRER 2014-10-30
- Status last verified
- Jan 2024
- First submitted
- 6 Jul 2017
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29391382
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03214263
- Acronym / sponsor ID
- REUM BIOMARKØRER 2014-10-30
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen, Copenhagen University Hospital at Herlev, King Christian X´Hospital for Rheumatic Diseases, Svendborg Hospital, Zealand University Hospital, Aalborg University Hospital, Aarhus University Hospital, Sygehus Lillebaelt, Odense University Hospital, Hillerod Hospital, Denmark, Randers Regional Hospital, University Hospital Bispebjerg and Frederiksberg
- Study start
- May 2015
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Derived from this study: PubMed 29391382Kringelbach 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.
- Bio- and GenomeBank Denmark and Danish Rheumatologic BiobankLink provided by the sponsor.
- DANBIOLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete L Hetland, Professor principal investigator
Rigshospitalet, Glostrup, Denmark
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid and Psoriatic Arthritis, run by Copenhagen University Hospital, Rigshospitalet at 11 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merete L Hetland, Professor, MD, DMSc, PhD (0045-38633330, merete.hetland@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03214263, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.