Research Studies in rheumatology
We have lots of opportunities for patients to become involved in research. We welcome enquires about participating in any studies. Please ask a member of your clinical team or contact our advice line and request a call back from our research nurses if you are interested in learning more about any of these studies.
Spondyloarthritis
British Axial Spondyloarthritis Inception Cohort (BAxSIC)
Aim: This study looks at the impact of delay in diagnosis of this condition on patient outcomes. It also evaluates the impact of this delay on future treatment options as well as trying to understand predictors of poor outcome from real world data.
Patient group: If you are a patient above the age of 16 recently diagnosed with Axial Spondyloarthritis or Ankylosing Spondylitis, you may qualify for this study.
IDEAL BACKPACS
(Improving the Diagnosis and Early referral of patients with AxiaL spondyloarthritis: BACK Pain referral pAthway from Community to Specialist care)
Aim: To determine the optimum referral strategy for identification of Axial Spondyloarthritis. It also aims to understand if patient self-assessment has the potential to reduce delays in diagnosis
Patient group: Patients aged 16-50 years with onset of back pain before age 45 years, symptomatic for at least 3 months and who have not yet been diagnosed with axial spondyloarthritis or another form of inflammatory arthritis. Patients must be willing and able to undergo an MRI scan as well as blood tests. A substudy will collect blood samples for biomarkers as a national repository for axial spondyloarthritis.
EXPEDITE
(Real-World Impact of Bimekizumab on Disease Activity in Axial Spondyloarthritis patients including the early subpopulation)
Aim: To evaluate impact of Bimkeizumab on Disease activity in Axial Spondyloarthritis at 12 months of treatment.
Patient Group: Any patient aged 18 or above who is diagnosed with Axial Spondyloarthritis who is initiating treatment with Bimekizumab
British Society for Rheumatology Psoriatic Arthritis Register (BSRBR-PsA)
Aim: To study the impact of psoriatic arthrtitis and its treatment on patient outcomes
Patient group: Any patient aged 16 years or above with a diagnosis of Psoriatic arthritis who is about to start treatment with disease modifying drugs or a biologic agent.
Inflammatory Arthritis/ Rheumatoid arthritis
British Society for Rheumatology Biologics Register for Rheumatoid Arthritis( BSRBR-RA)
Aim: To compare safety outcomes in patients with Rheumatoid arthritis starting new biologic agent.
Patient Group: Any patient diagnosed with Rheumatoid arthritis above the age of 16 years within 6 months of starting biologic therapy.
North East Early Arthritis Cohort – NEAC
Aim: To identify prognostic and therapeutic biomarkers in a cohort of patients from the early arthritis clinic in the north east.
Patient group: Any patients with suspected inflammatory arthritis aged 18 or above
Stratification of response to biologic therapy in Inflammatory Arthritis: BioRES
Aim: To assess predictors for response to biologic therapy in patients with inflammatory arthritis
Patient group: Any patients with Rheumatoid arthritis or Psoriatic arthritis initiating biologic therapy who have a swollen joint amenable to a biopsy of joint lining.
Juvenile Onset rheumatic diseases: EdUcation, vocational ReadiNess, & EmploYment (JOURNEY)
Aim: To compare educational outcomes and career aspirations in young adolescents with juvenile rheumatic diseases
Patient group: Adolescents or young adults (aged 12-30 years) with a diagnosis of juvenile onset rheumatic disease
REmission induction of Arthritis caused by Cancer ImmunoTherapy (REACT)
Aim: To determine the proportion of patients with steroid free remission from inflammatory arthritis induced by immune check point inhibitors (ICI) prescribed for cancer treatment
Patient group: Any patient aged 18 or more with ICI induced inflammatory arthritis
Remote monitoring for rheumatoid arthritis flare during drug tapering (Beyond Remission WP2)
Aim: To study the use of accelerometers (physical activity monitors) for the detection of rheumatoid arthritis flare during arthritis drug tapering
Patient group: Patients over 18 years old with established rheumatoid arthritis who are tapering an arthritis drug
SustaINed drug-Free remissiON in rheumatoId Arthritis (SINFONIA)
Aim: To characterise the features of the immune system in patients with rheumatoid arthritis who have achieved drug-free remission, and to explore patients’ views of stopping arthritis drugs
Patient group: Patients over 18 years old with established rheumatoid arthritis
AMGEN FRONTIER
Blinatumomab in Active Refractory Rheumatoid Arthritis (RA)
Aim: To Assess the Safety, Tolerability, and Efficacy of Subcutaneously Administered Blinatumomab in Participants With Active Refractory Rheumatoid Arthritis. Blinatumomab is a Bi-specific (anti-CD3/anti-CD19) T-cell Engager (BiTE) that results in deep B-cell depletion.
Patient Group: Adult participants (18 – 75 years) with active refractory rheumatoid arthritis. Active and refractory RA refers to the absence or incomplete response to the previous standard therapies used to treat rheumatoid arthritis including biologics. Participants will need to attend the clinical research facility weekly for 12 weeks for blinatumomab injection and be monitored for 6 hours post injection.
Controlling Hyperactive Immunity with Long-lasting Lymphocytes (CHILL)
Aim: to evaluate the safety and clinical activity of QEL-005, an autologous CAR T regulatory cell treatment targeting CD19, in patients with diffuse cutaneous systemic sclerosis (dcSSc) and in patients with difficult to treat rheumatoid arthritis (D2TRA).
Patient Group: Adult participants (18 years and above) with difficult to treat rheumatoid arthritis (D2TRA). D2TRA refers to those with ongoing active disease and has inadequate response to previous therapies of rheumatoid arthritis including at least two classes of targeted therapies. It is a one-off therapy with genetically modified autologous regulatory T-cells. Participants will undergo leukapheresis so that their regulatory T-cells can be harvested and then receive their modified cells back up to 8 weeks later.
ISTESSO
A Randomised, Double-Blind, Placebo-Controlled Trial of the Effects of Leramistat (MBS2320) on Muscle in Participants with Rheumatoid Arthritis
Aim: To evaluate whether leramistat has anti-sarcopenic and bone-protective actions in patients with RA.
Patient group: Adult participants (18 years and above) with controlled rheumatoid arthritis (low disease activity) and on a stable dose of methotrexate for at least 3 months. Treatment is for 6 months with leramistat or matching placebo. Participants will undergo muscle biopsy on 2 occasions, as well as MRI of the lower limbs, DEXA scans and tests of muscle strength.
Connective tissue diseases
GCA PMR- Consortium
Aim: To find genetic determinants of susceptibility to giant cell arteritis (GCA) and polymyalgia rheumatica(PMR). The study also aims to characterise disease on the base of clinical features, life impact and long term outcomes.
Patient group: Any patient with a diagnosis of GCA or PMR aged 50 years or above
European Scleroderma Trials and Research group (EUSTAR)
Aim: To improve treatment, quality of life and prognosis of patients with systemic sclerosis
Patient group: Any patient with systemic sclerosis or systemic sclerosis spectrum disorder aged 18 or above
Understanding the pathogenesis of vasculitis (POV)
Aim: to characterise patients with vasculitis on the basis of demographics, laboratory and imaging data
Patient group: Patients with a diagnosis of vasculitis aged 18 years or older.
The Sjogren’s Syndrome Research Database (Sjogren’s database)
Aim: To create a research database of patients with Sjogren’s syndrome
Patient group: Patients with Sjogren’s syndrome attending Newcastle hospitals
BILAG Biologics Prospective Cohort: The Use of Novel Biological Therapies in the Treatment of Systemic Lupus Erythematosus (SLE)
Aim: To ascertain whether using biologics in routine treatment of SLE is associated with an increased risk of being hospitalised due to infection when compared to SLE patients on conventional therapies.
Patient group: Any patient diagnosed with sLE aged 16 years or older who is commencing biologic treatment.
Rare diseases
Rare and Undiagnosed diseases Study (RUDY)
Aim: To determine the burden of rare disease and improve understanding of all aspects
Patient group: Patients of any age diagnosed with a rare disorder (prevalence of <5:10,000) and their blood relatives
