Rheumatology Current Research

The BSRBR-RA study tracks the progress of people with rheumatoid arthritis (RA) who have been prescribed biologic (including biosimilar) and other targeted therapies in the UK, to monitor the long-term safety of these drugs.

Project Details
Principal Investigator: Dr Paul Creamer
Planned End Date: 30/09/2028
Local Ref: 3512

The study evaluates the long-term course of PsA and,patients are followed up annually, comprising patient and treatment characteristics, clinical parameters,patient-defined benefit, quality of life and adverse events. In addition, patients starting a boDMARD, bsDMARD, or tsDMARD agent (either at recruitment or subsequently) will be followed up three and six months after the commencement of that therapy, with the follow-up schedule being ‘reset’ in the event of switching between therapies. Questionnaire follow-up is tied to patients’ anticipated clinical visit schedule, and clinical centres are contacted regarding any patients lost-to-follow- up. Safety issues, serious adverse events and supplementary information are collected by standardised forms.

A biobank is also being created as part of the study. Where local facilities allow, participants may be asked to donate tissue samples (blood and urine) which, alongside the extensive clinical phenotyping, will help facilitate biomarker evaluation and the identification of specific bio-molecular predictors of treatment response.

Project Details
Principal Investigator: Dr Paul Creamer
Planned End Date: 30/09/2024
Local Ref: 4721

Systemic sclerosis or scleroderma is an autoimmune condition that causes thickening and hardening of the skin, but can also affect internal organs.

There are two major subsets of scleroderma: the limited cutaneous systemic sclerosis (lcSSc) that usually affects the skin of the face, neck, lower legs or lower arms, but can also lead to internal organ complications, and the diffuse cutaneous systemic sclerosis (dcSSc), that may affect blood circulation and internal organs, as well as the skin.

To date there is no drug that has been definitively proven to cure or modify the course of scleroderma. However, there is emerging evidence that immunosuppression and specifically mycophenolate mofetil (MMF) may be beneficial in lcSSc. The MINIMISE-Pilot trial would be an important first step to evaluate the risk and potential benefit to this disease group. MMF as the intervention of choice is both appropriate and timely, as it has been routinely used in the management of dcSSc.

The MINIMISE-Pilot trial aims to explore whether the immunosuppressive agent MMF at a target dose of 2g daily can slow down disease progression in patients with lcSSc compared to the current standard of care alone. This pilot trial will also provide critical information for the development of a future large trial that could potentially transform lcSSc patient management. This is an open label randomised prospective trial that will recruit 120 participants aged 18 or over across 13 sites in the UK. The trial will involve five (5) clinic visits which are expected to be carried out at the same time of the participants routine hospital appointment. In addition, they will receive four (4) routine telephone calls in between their clinic visits. Participants are expected to be followed up for a minimum of 48 weeks or a maximum of 96 weeks.

Project Details
Principal Investigator: Dr H Gunwardena
Planned End Date: TBC
Local Ref: 4766

Primary systemic vasculitidies (PSV), encompassing Anti-Neutrophil Cytoplasmic Antibody (ANCA) associated vasculitis and medium vessel vasculitis, are relatively uncommon diseases, but have a propensity for renal involvement and account for a significant number of patients with both acute and chronic kidney disease. The aetiology of PSV is unknown and current therapies are non-specific and associated with major side effects. Outcome data for such patients have comprised small cohort studies from single centres. Understanding the factors that influence disease outcome and the impact different therapies have outside of clinical trials can only be achieved using a larger number of patients, accrued from multiple different units.

We propose to establish the first pan-UK PSV dataset, which will collect regular returns regarding patient recruitment and outcome from all participating centres. This will facilitate investigation of disease associations, outcomes and demographic trends for the UK PSV population. We will test the hypothesis that disease incidence is increasing in Indo-Asians and why the outcome may be different among different ethnic groups, as well as investigating contemporary outcomes with modern immunosuppressive protocols. In addition, we will combine clinical phenotype with genetic studies. Specifically we will investigate genetic variation between ethnic groups by looking at variations in DNA sequences that can help to explain differences in disease susceptibility. These are investigated using many DNA specific markers, called single-nucleotide polymorphisms (SNPs) whose expression will be compared between patients from different ethnic groups.

Finally, we will be able to record the outcome of all patients treated with novel therapeutics, thus eliminating the significant reporting bias that exists. This will allow individual investigators to carry out particular projects mining the dataset.

Project Details
Principal Investigator: Dr Albert Power
Planned End Date: 28/02/2022
Local Ref: 3724

The BILAG Biologics Prospective Cohort is a prospective observational cohort study of patients with SLE who are starting treatment with a biologic drug or a conventional, non-biologic therapy. The study aims to recruit 220 patients into the biologic treatment group and a further 220 patients into the conventional, non-biologic therapy cohort.

The aim of the BILAG BR is to ascertain whether using biologics in the routine treatment of SLE is associated with an increased risk of hospitalisation for infection, compared to SLE patients with similar disease activity receiving conventional therapies. The secondary purpose of the BILAG Biologics Prospective Cohort is to determine the long-term efficacy of biological therapies in the treatment of SLE.

This prospective cohort study will recruit an exposed cohort of patients with SLE treated with biological therapies and an unexposed cohort of patients with similar disease characteristics but exposed only to conventional non-biological therapies. Comprehensive data will be collected at baseline, from the clinic team and the patient, including data on disease diagnosis and activity, risk factors for infection and routine laboratory results. Follow-up data will be collected at 3, 6, 12, 24 and 36 months to include any changes in medications, adverse events, hospitalisations for infections, disease activity and quality of life along with biological samples for biomarker analysis.

Project Details
Principal Investigator: Dr Harsha Gunawardena
Planned End Date: 31/12/2022
Local Ref: 8251

Idiopathic Inflammatory Myopathies (IIM), also know as myositis, is a rare condition that causes inflammation of the muscles and can result in weakness, fatigue and disability. It can also affect other parts of the body including the skin, joints, heart, lungs and digestive tract. Treatment involves the suppression of inflammation using anti inflammatory medication before permanent damage results. However, the outcome for patients with myositis is not as good as it could be and needs to be improved. For this reason we are planning a research study to find better ways to diagnose, treat and improve the care of patients with myositis.

Patients wishing to take part will ideally attend for 4 study visits over the course of 12 months. If they continue to be seen at the hospital, they may also be asked to provide further blood samples and information on an annual basis for 5 years. At the initial visit they will be asked to sign a consent form, give a blood sample, undergo a clinical assessment and complete a number of questionnaires. Additionally (as part of their routine clinical care), they will be asked to undertake an MR scan of their muscle, a muscle biopsy, and be given the option of an MR contrast scan of their heart (these clinical results will be used as part of research findings. Follow up visits at 3, 6 and 12 months will involve further blood samples, clinical assessments and questionnaires. Additionally, they will be given the option of a second MR muscle scan, a repeat muscle biopsy and an MR contrast scan of their heart at the 6 month follow up visit.

It is hoped that the information gained from this study will help identify better ways to diagnose, treat and improve the care of patients with myositis.

Project Details
Principal Investigator: Dr Harsha Gunawardena
Planned End Date: 31/12/2020
Local Ref: 3793