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| Name | Class |
|---|---|
| University Hospital, Gentofte, Copenhagen | OTHER |
| Copenhagen University Hospital at Herlev | OTHER |
| King Christian X´Hospital for Rheumatic Diseases | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Merete L Hetland, Professor, MD, DMSc, PhD | Contact | 0045-38633330 | merete.hetland@dadlnet.dk |
| Name | Affiliation | Role |
|---|---|---|
| Merete L Hetland, Professor | Rigshospitalet, Glostrup, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Rheumatology, Aalborg University Hospital | Recruiting | Aalborg | Denmark | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29391382 | Derived | 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. |
| Label | URL |
|---|---|
| Bio- and GenomeBank Denmark and Danish Rheumatologic Biobank | View source |
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| Svendborg Hospital |
| OTHER |
| Zealand University Hospital | OTHER |
| Aalborg University Hospital | OTHER |
| Aarhus University Hospital | OTHER |
| Sygehus Lillebaelt | OTHER |
| Odense University Hospital | OTHER |
| Hillerod Hospital, Denmark | OTHER |
| Randers Regional Hospital | OTHER |
| University Hospital Bispebjerg and Frederiksberg | OTHER |
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EDTA-whole blood, EDTA-plasma, EDTA-buffy coat, serum, synovial fluid, tissue, PAXgene RNA tubes
| Department of Rheumatology, Aarhus University Hospital |
| Recruiting |
| Aarhus |
| Denmark |
| Department of Rheumatology, Rigshospitalet | Recruiting | Copenhagen | Denmark |
| Dept. of Rheumaology, University Hospital Bispebjerg and Frederiksberg | Recruiting | Copenhagen | Denmark |
| Dept. of Rheumaology, North Denmark Regional Hospital | Recruiting | Hjørring | Denmark |
| Department of Rheumatology, Zealand University Hospital Køge | Recruiting | Køge | Denmark |
| Department of Rheumatology, Odense University Hospital | Recruiting | Odense | Denmark |
| Dept. of Rheumaology, Randers Regional Hospital | Recruiting | Randers | Denmark |
| Department of Rheumatology, Svendborg Hospital | Recruiting | Svendborg | Denmark |
| Danish Arthritis Hospital | Recruiting | Sønderborg | Denmark |
| Department of Rheumatology, Hospital Lillebaelt | Recruiting | Vejle | Denmark |
| DANBIO | View source |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| D000089183 | Axial Spondyloarthritis |
| D003240 | Connective Tissue Diseases |
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D000844 | Ankylosis |
| D000070657 | Crystal Arthropathies |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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