Current Research Studies

To view the procedure you must follow to seek approval for your research study to be advertised on the ARA website click here.

Information regarding studies that are currently recruiting participants  can be found below.

The Arthritis Australia website also has a page where consumers can express interest in joining a research study. 

Project Title
A multicentre, open-label randomised controlled trial of DMARD dose maintenance (USUAL CARE) vs DMARD discontinuation after reduction (TAPER) in adult patients with rheumatoid and psoriatic arthritis (RA and PsA) on stable b/tsDMARD therapy +/- csDMARD/s, who are in sustained low disease activity at baseline for cost-utility comparison and multiomic mechanistic analyses to predict success of down-titration strategies

Principal Investigators

• Prof. Lyn March (Royal North Shore Hospital, NSW)
• Prof. Marissa Lassere (St George Hospital, NSW)
• Prof. Peter Youssef (Royal Prince Alfred Hospital, NSW)
• Prof. Catherine Hill (The Queen Elizabeth Hospital, SA)
• Prof. Susanna Proudman (Royal Adelaide Hospital, SA)
• A/Prof. Mihir Wechalekar (Flinders Medical Centre, SA)
• Prof. Rachelle Buchbinder (Malvern Clinic, VIC)
• Dr. David Liew (Austin Health, VIC)
• A/Prof. Helen Keen (Fiona Stanley Hospital, WA)
• Dr. James Gray (Princess Alexandra Hospital, QLD)
• Dr. Matthew Terrill (Sunshine Coast University Hospital, QLD)

Broad Aims of this Project

• To evaluate efficacy, safety, and cost effectiveness of down-titration strategies of b/tsDMARD therapies in adults with well-controlled RA and PsA.
• To identify clinical and biomarker predictors of success or failure of down-titration strategies.
• To generate algorithms for predicting who can safely and successfully reduce biologic therapy.

Reasons for Doing this Research Project
Long-term use of the immunomodulating DMARD therapies may lead to overtreatment, with elevated risks of adverse events and unnecessary costs, however there is currently no clear guidance for when, how to, and who can withdraw therapies in RA or PsA. International consensus on the safest reduction protocols and predictors of success are severely lacking and there are no data in the Australian context where criteria for accessing biologics differs in important ways from the rest of the world. Trials to-date have primarily been conducted with the anti-TNF bDMARD agents, they have not always had a usual-care comparator arm and many have been conducted in the setting of relatively early disease and are not generalisable to all. This trial will substantially address these uncertainties and will enhance the implementation of down-titration strategies if proven to be safe and cost-effective in the Australian setting.

Recruitment of Participants and Selection Criteria 
Participants will be approximately 270 adults with well-controlled RA or PsA across 11 sites.
Major selection criteria include that subjects:

• first started any b/tsDMARD with or without csDMARD ≥18 months ago;
• are in remission or low disease activity and have been stable on DMARD for ≥6 months, and
• if participants are on oral corticosteroids, the dose must be stable and ≤5mg prednisone daily equivalent;
• have not had any parenteral or intra-articular corticosteroid injections in the last 6 months;
• are not pregnant or have had an investigational new drug within the last 12 weeks.

Ethics Approval Details
Northern Sydney Local Health District (NSLHD) Human Research Ethics Committee (HREC) Approval Number: 2021/ETH11902
Australian New Zealand Clinical Trials Registry Number: ACTRN12621001695897

Time Period of the Research Project
Anticipated end date by Jun 2027

For Further Information
Contact 02 9463 1758 or email prospect.trial@sydney.edu.au
Click here for Health Professionals Brochure

Project Title
The relationship between structural and functional lower limb characteristics, fall history and postural balance in Psoriatic Arthritis: a cross-sectional study.

Principal Investigators

• Dr Justin Holland, School of Exercise and Nutrition Sciences, QUT: Senior Lecturer in Exercise Physiology
• Professor Deborah Turner, School of Clinical Sciences, QUT: Professor in Podiatry
• Dr Sheree Hurn, School of Clinical Sciences, QUT: Senior Lecturer in Podiatry
• Ms Katie Green – Research Associate, School of Clinical Sciences, Faculty of Health.

Broad Aims of this Project

• This study firstly aims to compare balance and functional ability in participants with PsA compared to matched control participants without PsA. Secondary aims are to compare characteristics (disease activity, foot and ankle characteristics, functional ability) between fallers and non-fallers in those with PsA; and to explore correlations between participants’ characteristics and their functional performance. This study thereby aims to identify factors which may be correlated with balance impairment in this population group and contribute to filling this knowledge gap. This is important as the first step in developing remedies to the possible problem of falls associated with PsA.

Reasons For Doing This Research Project

• Disease symptoms of the foot have the potential to negatively influence postural balance in PsA, being present in 50 – 70% of those with the condition (Krakowski et al., 2019). Correlations between foot and ankle problems, reduced balance and fall risk have been found in older adults (Awale et al., 2017; Menz, Auhl, & Spink, 2018), but no relationship has yet been found in those with PsA. Carter, Walmsley, Oliffe, Hassett, and Turner (2021) discovered foot pain and deformity to be common amongst those with PsA who reported a history of falls, thus highlighting the possibility of a link between disease of the foot and balance impairments. In PsA, the predilection for foot involvement includes dactylitis (inflamed or “sausage” fingers or toes) (Mease et al., 2017) and enthesitis (calcification and inflammation of tendinous attachments) (Krakowski et al., 2019; Mease et al., 2017). Foot deformities have been reported to negatively impact foot function in both PsA (Patience, Helliwell, & Siddle, 2018) and rheumatoid arthritis (Bal, Aydog, Aydog, & Cakci, 2006). Although the study investigating balance in PsA (Duruoz, Baklacioglu, Toprak, Atalay, & Atagunduz, 2018) found balance impairments, they failed to find any correlations with foot characteristics or disease severity. However, the sample in the study may not be generalisable to the PsA population, due to their exclusion of those with contractures and active arthritis in the foot.
• Postural balance impairments may also arise in those with PsA due to co-morbidities. Frequently associated with PsA are obesity and diabetes (Ritchlin, Colbert, & Gladman, 2017). Arising from diabetes is polyneuropathy, the most common complication of diabetes, occurring in ~ 50% of those with the disease (Juster-Switlyk & Smith, 2016). Of particular concern, is the fact that diabetic neuropathy can negatively affect ankle motor function and increase falls risk (Gutierrez, Helber, Dealva, Ashton-Miller, & Richardson, 2001). However, nothing is known about the potential influence of diabetic neuropathy on postural balance in PsA.
• Finally, fear of falling (FOF) may also exist in PsA, although this is unknown. In other populations, FOF is associated with an increased risk of falling and a reduction in physical and social activities. This results in a decline in physical function, less inclination to be active and a downward spiral of mental and physical health and QoL (Peeters, Bennett, Donoghue, Kennelly, & Kenny, 2020). Those with PsA have a significant reduction in their QoL, not only from PsA but from the co-morbidities that are commonly associated with the condition. The discovery of a history of falls in PsA individuals is yet another complication for this population. These are relatively young individuals to be confronted by postural balance impairments. They are of working age and falls may lead to injury and time off work. In addition, balance impairments have the potential to produce a fear of falling, which can lead to loss of confidence, activity avoidance, reduced physical function, social withdrawal and overall decreased QoL. It is therefore important to investigate what may be contributing to postural instability in this population.
• To date, the problem of falls in PsA is not widely recognised amongst clinicians or in the literature. Furthermore, there is no understanding of why postural balance may be impaired in PsA. In summary, there are various features of PsA which could feasibly be responsible for an increased fall risk in those with the disease, but research is presently lacking in this space.

What are you trying to achieve?

• Firstly, this research expects to confirm the existence of balance impairment in those with PsA and highlight the problem in this population. With recognition, comes motivation for the scientific community, clinicians and individuals with PsA to seek methods to improve their postural balance. In addition, this study is expected to discover if features typically found in PsA are associated with balance deficits. This discovery would, in turn, be expected to lead to strategies to positively influence any modifiable features associated with balance impairment.
• If postural balance is found to be impaired in PsA, this study will inform the design of an interventional study exploring targeted intervention strategies to reduce falls risk in those with PsA. If the intervention is successful, it will give those with PsA a strategy for improving their balance and quality of life.

Recruitment of Participants and Target Audience 

• Participants will be approximately 30 adults with a confirmed diagnosis of PsA, made by a rheumatologist with working knowledge of PsA. The length of time since their diagnosis will be recorded and a record of their fall history will be taken. PsA participants will be divided into 2 groups, according to whether they have had a fall in the past year, or not. This timeframe is regularly used in studies to differentiate between “fallers” and “non-fallers”.A corresponding number of individuals will be recruited for the non-PsA control group, matched for age, sex and BMI.
• Inclusion and exclusion criteria: Adults with PsA, aged 18 and over, will be included in this study. Individuals with PsA will not be excluded on account of co-morbidities, since these are frequent complications of their disease. Mobility amongst those with PsA needs to be sufficient to perform the gait tests. Some walking aids (walking-stick variations) can be accommodated, but those using wheelie walkers or wheel chairs will be excluded.
  Individuals volunteering for the control group will be excluded if they are an active recipient of care for arthritis or a musculoskeletal condition of the lower limb; if they have had an injury or surgery of the lower limb in the last 6 months; if they have peripheral sensory loss; or if they have a neurological condition.
  Pregnant women will be excluded from the study, due to changes in ligament laxity and postural balance.

Ethics Approval Details

• This project has been approved by the QUT HREC approval number HREA 2023-5243-12552

Time Period of the Research Project

• Anticipated finish date December 2024.

For Further Information

• Contact Dr Justin Holland: Justin.holland@qut.edu.au  / 0400 024 492

Project Title
Attitudes of Healthcare Professionals and Patients with Rheumatoid Arthritis towards Parenteral Use of Methotrexate in Rheumatoid Arthritis Patients: A Qualitative Study.

Principal Investigators

• Professor David Hunter
• Professor Changhai Ding

Broad Aims of this Project

• To assess the effect of knee intra-articular injections of allogeneic mesenchymal stem cells (MSCs) compared with placebo (saline) on patient-reported outcome measures and joint structure over 24 months in people with knee OA.
• We would like to explore different ways to boost recruitment of study participants. The idea is that we would pay 10 AUD per referral from any health care provider. If the person is ultimately enrolled in the study, the referring professional will receive an additional 100 AUD. We will ensure that participants are fully aware that their participation is entirely voluntary regardless of the recruitment source.

Reason for Doing this Research Project 

• Knee osteoarthritis is the leading cause of lower-limb disability in older people and a prevalent problem for Australians. To reduce social and individual burdens, new treatments that can slow or stop disease progression are needed. Stem cell therapy has been increasingly utilised for osteoarthritis, with the belief that it prevents joint destruction and stimulates regeneration. However, the medical opinion remains highly controversial, given the considerable treatment cost and limited scientific evidence to support stem cell efficacy and safety in treating osteoarthritis. With that in mind, the SCUlpTOR study aims to ascertain whether intra-articular stem cell injections improve symptoms and slow disease progression in people with mild to moderate knee osteoarthritis.

Recruitment of Participants and Target Audience

• We would like to target health professionals who treat people with knee OA and may be interested in referring patients to the trial.

Ethics Approval Details

• The University of Sydney (USYD) Human Research Ethics Committee (HREC) #: 2020/119 (lead HREC)

TIme Period of the Research Project

• Anticipated finish date by December 2024.

For Further Information  

• Contact Sarah Robbins   E: sculptor.trial@sydney.edu.au       W: 02 9463 1855
• Click here for Health Professionals Flyer

Project Title

Multimodal MRI of myalgic encephalomyelitis/chronic fatigue syndrome: a cross-sectional neuroimaging study towards its neuropathophysiology and diagnosis

Principal Investigators

• Dr Zack Shan PhD, Thompson Institute, University of Sunshine Coast
• Dr R Kwiatek FRACP, Private Rheumatology Practice, North Adelaide
• Dr P Del Fante FRACGP, Private General Practice, Adelaide
• Assist/Prof C Chang PhD, Vanderbilt University, USA
• Prof V Calhoun PhD, The George State University, USA
• Prof J Lagopolous PhD, Thompson Institute, University of Sunshine Coast
• Prof D Hermens PhD, Thompson Institute, University of Sunshine Coast

Broad Aims of this Project

To investigate hypotheses of 

• (i) Slowed hemodynamic response function (HRF) and elevated glutamate levels during brain function underpin the underlying neurological disease process in ME/CFS and fibromyalgia syndrome (FMS); and 
• (ii) A multimodal MRI neuromarker, from the integration of structural, neurochemical, functional MRI measures, can be utilised to for objective diagnose of ME/CFS and FMS.

Reason for Doing this Research Project 

• Incompletely understood ME/CFS and FMS (still regarded as a rheumatological disorder as its cardinal feature is widespread musculoskeletal pain) are closely related common functional somatic disorders causing major morbidity and economic loss within the Australian population, easily competing with inflammatory RMD as having unmet clinical needs. ME/CFS and FMS can be regarded as existing on a clinical phenotypic spectrum with most of those afflicted meeting diagnostic criteria for both.

Recruitment of Participants and Target Audience

• Community individuals with FMS. Inclusion and exclusion criteria are strict and are summarised here.

Ethics Approval Details

• USC Ethics Approval Number A191288
• Australian New Zealand Clinical Trials Registry Number: ACTRN12622001095752

Time Period of the Research Project

• Recruitment to finish December 2025.

For Further Information

• Contact 07 5456 5445 or email cfs@usc.edu.au
• Click here for Fibromyalgia Research Study information.