The Australian Arthritis and Autoimmune Biobank Collaborative (A3BC): a national study collecting broad data and biological samples from individuals with arthritis and autoimmune diseases for research towards safer, more effective and evidence-based prevention, diagnosis, treatment and outcome strategies.
The Australian Arthritis and Autoimmune Biobank Collaborative (A3BC): a national registry and biobanking network for multi-centre prospective longitudinal collection, processing and storage of broad patient-reported and clinical/health data, and high-quality biospecimens from participants with arthritis and autoimmune diseases
University of Sydney
20,000 participants
May 14, 2019
Observational
Conditions
Summary
The Australian Arthritis and Autoimmune Biobank Collaborative (A3BC) was established in 2016 by Australian rheumatologists and researchers to address the urgent need for better prediction of prognosis and treatment outcomes among Australians living with arthritis and autoimmune conditions. The group identified that building a state-of-the-art national resource would not only improve outcomes but also strengthen research capacity in a significantly underfunded National Health Priority Area, given the disproportionate burden and cost of musculoskeletal (MSK) conditions. The A3BC’s vision is to identify the causes and cures of MSK and autoimmune diseases through biobank-enabled, data-linked, collaborative, and multidisciplinary research. Now merged with the Australian Rheumatology Association Database (ARAD), integrated with the Australian Juvenile Arthritis Registry (AJAR), and partnered with the Australian and New Zealand ChiLdhood Arthritis Risk factor Identification sTudY (ANZ CLARITY), the A3BC provides a powerful platform. It combines biological and environmental data with patient and population datasets to reveal new associations that will lead to safer, more effective prevention, diagnosis, treatment, and prognosis strategies. Beyond high-quality biospecimen collection, the most innovative feature of the A3BC is the unprecedented level of integrated data analysis. The A3BC will link biospecimen-derived ‘omic’ data with patient-reported outcomes, cross-jurisdictional electronic medical records (EMR), imaging and pathology data, national datasets (MBS, PBS, AIR), cancer and death registries, and longitudinal studies. This integration offers a comprehensive platform for transformative research. Initially focusing on Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Juvenile Idiopathic Arthritis (JIA), Ankylosing Spondylitis (AS), gout, and vasculitides (including Polymyalgia Rheumatica and Giant Cell Arteritis), the A3BC infrastructure will enable expansion to other significant or rare MSK conditions. These include Sjögren's Syndrome, Low Back Pain, Scleroderma, Systemic Lupus Erythematosus, Myositis, and Osteoarthritis. A broad range of childhood and adolescent MSK conditions, in addition to JIA will gradually be added, including but not limited to, juvenile systemic lupus erythematosus, juvenile scleroderma, juvenile dermatomyositis, juvenile vasculitis (e.g. Kawasaki’s, Henoch-Schonlein), and congenital skeletal dysplasias. Built on a national network of integrated registry, biobank, and research infrastructure, supported by leading clinical and scientific expertise, the A3BC promises a new era of evidence generation. It will deliver a cost-effective, future-focused research platform to drive smarter health policy, better clinical decision-making, and ultimately, new paths to diagnosis, treatment, and prevention.
Eligibility
Inclusion Criteria40
- ALL DISEASES
- Male, female or non-binary
- Aged from 0-18 years for childhood musculoskeletal and autoimmune diseases.
- Aged over 18 years for adult musculoskeletal and autoimmune diseases.
- Allow their rheumatologist/ specialist to be notified of participation.
- Formally diagnosed under validated classification systems related to the disease.
- Able (in the Investigator’s opinion) and willing to comply with all study requirements.
- Participant (or parent/guardian) is willing and able to give informed consent for participation.
- Aged over 18 years
- Controls are classified into three main subtypes:
- a. At-Risk* first-degree and second-degree relatives of existing A3BC participants.
- b. Healthy or at-risk* family and friends accompanying existing A3BC participants to their routine clinic visits.
- c. Healthy or at-risk* general members of the community.
- Definitions of healthy or at-risk controls are detailed on a project-specific basis
- RA
- RA after symptom onset
- Diagnosed with RA under the 2010 Rheumatoid Arthritis Classification Criteria published by the American College of Rheumatology (Group 1).
- JIA
- Children and adolescents aged 0-18 years.
- Diagnosis of JIA (under ILAR Classification)
- PsA
- At least 18 years of age
- Diagnosis of PsA under the CASPAR Classification System
- AS, nr-axSpA or PERIPHERAL SpA
- At least 18 years of age
- Diagnosis of AS under the modified New York Classification System or nr-axSpA / Peripheral SpA under the ASAS Classification Criteria
- VASCULITIS
- Diagnostic classification will be according to EULAR/ACR Criteria for each subtype of vasculitis:
- Small blood vessel vasculitis - Granulomatosis with polyangiitis (Wegener’s granulomatosis), Eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), Goodpasture’s syndrome (Anti-glomerular basement membrane disease), Henoch-Schonlein purpura (IgA Vasculitis), Microscopic polyangiitis, Cogan’s disease, Cryoglobulinaemic vasculitis and Urticarial vasculitis
- Medium blood vessel vasculitis - Behcet’s disease, Central nervous system vasculitis, Kawasaki disease, Polyarteritis nodosa
- Large blood vessel vasculitis - Giant cell (temporal) arteritis, Takayasu arteritis, Polymyalgia rheumatica
- In addition to EULAR/ACR Criteria, the rarer form of small blood vessel vasculitis, known as anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, will be identified by:
- Myeloperoxidase (MPO) or proteinase 3 (PR3) positive blood test (ELISA detection)
- ANCA-associated disease via vasculitis activity/ damage scoring (BVAS, DEI or VDI)
- IDIOPATHIC INFLAMMATORY MYOPATHIES
- Diagnosis under the 2017 EULAR/ACR IIMs Criteria Adult and Juvenile Idiopathic Inflammatory Myopathies
- SJOGREN'S SYNDROME
- Adults diagnosed under the 2016 EULAR/ACR Sjogren’s Syndrome Criteria or the American-European Consensus Sjögren’s Classification Criteria
- GOUT
- Adults diagnosed under the 2015 ACR/EULAR Gout Classification Criteria
Exclusion Criteria5
- ALL DISEASES
- Unable to speak English at a level capable of understanding the informed consent process, or lack of access to an interpreter to enable this level of understanding.
- Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’s ability to participate in the study. For example, cognitive impairment that would interfere with completing a self-administered questionnaire.
- Legacy/existing samples collected through participating sites will only be included in the A3BC network’s collections if they meet the current SOP parameters.
- Given the inherent variability in microbiome populations and the myriad external factors which are thought to affect human microbial populations, the A3BC will carefully document and adjust for these in planned microbiome-related analyses. Microbiome research is a rapidly evolving field and therefore these criteria will be updated as levels of evidence evolve. Particular confounding variables to be minimised/documented in both faecal and saliva collections include antibiotic use, use of commercial probiotic/prebiotic products and infections (all in the last 3 months).
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Interventions
Multi-centre prospective cohort of case and control biospecimens (Biobank) linked to longitudinal personal, patient-reported, clinical and health information (Registry). Biospecimens are collected at 0, 6, 12 and 24 months, with some ad hoc collections. Data are collected 6-monthly up to 24 months, then yearly afterwards for the life of the project – at least 20 years (open-ended). The questionnaires gather information on disease status, quality of life, function, medication history, medical illnesses, malignancy history, infections, lifestyle, diet and environmental/exposure history. Valid and reliable quality of life/function instruments are used. Participants’ health records are also accessed periodically through record linkage with federal/state health services and registries via Services Australia and the Australian Institute of Health and Welfare (National Health Data Hub). Participation is flexible and participants may opt in or out of parts of the study if they wish e.g. registry-only participation. Target cohorts include: At-Risk Cohort Purpose: Identify predictors and mechanisms of disease onset in people at high risk of developing inflammatory arthritis or autoimmune disease. Eligibility: • No confirmed inflammatory arthritis or autoimmune disease, but presence of disease-associated risk factors, such as: o Clinically suspect arthralgia (CSA) of less than 1 year duration, with MCP involvement and greater than 60 minutes of morning stiffness. o Family history of autoimmune or inflammatory arthritis (e.g. first-degree relatives of RA patients) o Presence of RA-associated autoantibodies (e.g. ACPA, RF) in asymptomatic individuals • Suitable for prospective monitoring and biospecimen collection to capture disease transition if/when it occurs Early Disease Cohort Purpose: Understand the earliest stages of inflammatory arthritis and autoimmune disease to inform personalised early treatment and prevention of progression. Eligibility: • Symptom onset within the past 12 months with diagnosed or undifferentiated inflammatory arthritis or autoimmune disease (refer to disease Eligibility Criteria). Starting DMARDs Cohort Purpose: Predict initial treatment response and inform early treatment decisions. Eligibility: • Active inflammatory arthritis or autoimmune disease (see disease Eligibility Criteria) • About to start a new DMARD for the first time or add a new DMARD to an existing regimen • Baseline biospecimens ideally collected prior to any systemic glucocorticoids (IV/IM/PO) or start of new DMARD/s (only NSAIDs and simple analgesics permitted) Switching DMARDs Cohort Purpose: Understand reasons for treatment failure and predict response to subsequent therapies. Eligibility: • Active inflammatory arthritis or autoimmune disease (see disease Eligibility Criteria) • Switching from one DMARD to another due to: o Lack of efficacy o Intolerable side effects or safety concerns o Disease relapse or flare on current regimen • Includes changes between csDMARDs and/or b/tsDMARDs Genetically Driven Disease Cohort Purpose: Explore the genetic factors underlying severe rheumatic diseases and their influence on disease progression and treatment response. Eligibility: • High suspicion of genetic contribution to the disease (see disease Eligibility Criteria) • Participants with severe manifestations of disease that are potentially linked to genetic factors • Conditions could include rare or extreme disease forms where genetic studies are critical for understanding disease mechanisms Difficult-to-treat (D2T) Disease Cohort Purpose: Identify factors that contribute to difficult-to-treat rheumatic diseases and explore management strategies for these patients. Eligibility: • Diagnosis of severe, active, and difficult-to-control inflammatory arthritis or systemic disease (see disease Eligibility Criteria) • Fulfills at least one of the following: EULAR definition of difficult-to-treat RA : 1) Failure of 2 or more b/tsDMARDs (with different mechanisms of action) after failing csDMARDs (unless contraindicated) 2) Presence of at least one of the following: o At least moderate disease activity o Signs and/or symptoms suggestive of active disease o Inability to taper glucocorticoid treatment o Rapid radiographic progression o RA symptoms that reduce quality of life 3) Management of disease symptoms is perceived as problematic by the rheumatologist and/or the patient • Could also include systemic inflammation with poorly controlled disease (e.g. autoimmune diseases like vasculitis, PMR, or others) Stopping DMARDs cohort Purpose: Predict who can sustain disease control/remission after abruptly stopping therapy. Eligibility: • Well-controlled inflammatory arthritis or autoimmune disease using established definitions of remission/low disease activity/clinically inactive disease (see disease Eligibility Criteria). • Participant will be abruptly stopping DMARD therapy as part of routine care. Tapering DMARDs cohort Purpose: Predict who can sustain disease control/remission after tapering therapy. Eligibility: • Well-controlled inflammatory arthritis or autoimmune disease using established definitions of remission/low disease activity/clinically inactive disease (see disease Eligibility Criteria). • Participant will be tapering DMARD therapy as part of routine care, including tapering towards eventual stopping Stable Disease Cohort Purpose: Enable studies of stable rheumatic disease states Eligibility: • Stable inflammatory arthritis or autoimmune disease, typically in remission or low-disease activity, with no plans for changes in treatment regimen at the time of enrolment (see disease Eligibility Criteria).
Locations(36)
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ACTRN12621001564842