University of Glasgow - Schools - School of Infection & Immunity - Research - Clinical Research - Clinical Trials

Closed Studies

Information on studies which have closed to recruitment or completed entirely are shown below. If you have any questions about our studies, please email us: arthritisresearch@glasgow.ac.uk

Scottish Early Rheumatoid Arthritis (SERA)

Study Title:

Scottish Early Rheumatoid Arthritis (SERA) biobank from an inception cohort of patients with newly diagnosed rheumatoid arthritis.

Study Protocol Here

Study Summary (including aims, timelines and funder):

The Scottish Early Rheumatoid Arthritis (SERA) study is an inception cohort of rheumatoid (RA) and undifferentiated arthritis (UA) patients that aims to provide a contemporary description of phenotype and outcome and facilitate discovery of phenotypic and prognostic biomarkers. Originally funded by the Chief Scientist Office and Pfizer, SERA is now closed to recruitment.

Study Outcome:

SERA was a population-wide inception cohort that recruited new onset rheumatoid arthritis patients (RA n=1173; Healthy Volunteers n=100) in a routine NHS setting. Clinical characteristics including therapeutics and disease activity parameters were recorded with a broad range of biobanked biological samples (>65,000 samples e.g. DNA, RNA, serum, plasma, urine).

Using the Community Health Index (CHI) number each participant is electronically linked to core NHS data services (Robertson Centre, Glasgow; Farr, Edinburgh) to track e.g. medical episodes, co-morbidities, death, community prescribing, in perpetuity.

In routine care, newly diagnosed RA/UA patients experience significant improvements in disease activity, functional ability and health-related quality of life but have high rates of multi-morbidity and declining employment rates. The co-existence of a multi-domain description of phenotype and a comprehensive biobank will facilitate multi-platform translational research to identify predictive markers of phenotype and prognosis.

GDPR Statement

The introduction of the GDPR regulations brings with it stricter requirements around how organisations inform people of how their personal data is being used for health and care research.

To meet this requirement the Health Research Authority (HRA) has issued guidance to those organisations to explain to you how we are using your personal data, and what your rights are under the law.

This information is outlined below and separate additional text has been published by the HRA on behalf of the NHS, to ensure that patients can find consistent transparency information.

SERA_GDPR notice V2.0 30.11.23

Publications:

2022

Frailty in rheumatoid arthritis and its relationship with disease activity, hospitalisation and mortality: a longitudinal analysis of the Scottish Early Rheumatoid Arthritis cohort and UK Biobank. RMD Open, 8(1), e002111. (doi: 10.1136/rmdopen-2021-002111) (PMID:35292529) (PMCID:PMC8928366

2021

Nijjar J, Morton FR, Bang H, Buckley CD, van der Heijde D , Gilmour A et al. The impact of autoantibodies against citrullinated, carbamylated, and acetylated peptides on radiographic progression in patients with new-onset rheumatoid arthritis: an observational cohort study. The Lancet. Rheumatology, 27 Jan 2021, 3(4):e284-e293

2020

Fragoulis G et al, Depression and anxiety in an Early Rheumatoid Arthritis inception cohort. Associations with demographic, socioeconomic and disease features. RMD Open 2020;6:e001376. doi: 10.1136/rmdopen-2020-001376

2019

Gabrielle Simoneau, Erica E. M. Moodie, Jagtar S. Nijjar, Robert W. Platt & the Scottish Early Rheumatoid Arthritis Inception Cohort Investigators (2019) Estimating Optimal Dynamic Treatment Regimes With Survival Outcomes, Journal of the American Statistical Association, DOI: 10.1080/01621459.2019.1629939

2018

Carini, C., Hunter, E., Porter, D. et al. Chromosome conformation signatures define predictive markers of inadequate response to methotrexate in early rheumatoid arthritis. J Transl Med 16, 18 (2018) doi:10.1186/s12967-018-1387-9

Ann Morgan, John Taylor, Tim Bongartz, et al, Genome-wide Association Study of Response to Methotrexate in Early Rheumatoid Arthritis Patients. The Pharmacogenomics Journal 2018 http://doi.org/10.1038/s41397-018-0025-5

Fragoulis GE, Paterson C, Gilmour A, et al. Neutropaenia in early rheumatoid arthritis: frequency, predicting factors, natural history and outcome. RMD Open 2018;4:e000739. doi:10.1136/rmdopen-2018-000739

2017

Siebert, S. et al. Urinary proteomics can define distinct diagnostic inflammatory arthritis subgroups. Sci. Rep. 7, 40473; doi: 10.1038/srep40473 (2017).

2016

Kronisch C, McLernon DJ, Dale J, Paterson C, Ralston SH, Reid DM, et al. Brief report: predicting functional disability: one-year results from the scottish early rheumatoid arthritis inception cohort. Arthritis Rheumatol. 2016;68:1596–602.

Dale J, Paterson C, Tierney A, Ralston SH, Reid DM, Basu N, et al. The Scottish Early Rheumatoid Arthritis (SERA) Study: an inception cohort and biobank. BMC Musculoskelet Disord. 2016;17:461.

2014

Stalmach A, Johnsson H, McInnes IB, Husi H, Klein J, Dakna M, et al. (2014) Identification of Urinary Peptide Biomarkers Associated with Rheumatoid Arthritis. PLoS ONE 9(8): e104625. https://doi.org/10.1371/journal.pone.0104625

ACR abstracts:

E Clark, C Wood, A Tindell, K Graham, A McIntosh, F Morton and D Porter. Unmet need in early rheumatoid arthritis - why do some patients do badly despite modern treat-to-target strategies of care? Results from the Scottish Early RA (SERA) inception cohort. https://acrabstracts.org/abstract/unmet-need-in-early-rheumatoid-arthritis-why-do-some-patients-do-badly-despite-modern-treat-to-target-strategies-of-care-results-from-the-scottish-early-ra-sera-inception-cohort/

D Porter, F Morton, S Jain. Increase rates of bacterial infection in patients with 'pre-RA' (submitted 2022)

ScOttish Psoriatic arthritis Observational Study and biobank (SOPHOS)

Study Title: ScOttish Psoriatic arthritis Observational Study and biobank (SOPHOS)

Study Summary

This study, funded by Chief Scientist’s Office (Scotland) and UCB Pharma, is a pan-Scottish study which aims to create a biobank of epidemiological, clinical, serological data and of biological samples in patients with newly diagnosed and established psoriatic arthritis.

What does the study involve?

Study Protocol here

The study is designed to be able to answer a number of different research questions, the precise analysis will depend on the specific question being asked but is likely to include identifying predictors of prognosis (good and bad outcomes) and treatment response. The data collected will also allow assessment of the burden of disease and treatment in patients with this chronic disease.

This study records information about each participant, including age, gender, BMI, blood pressure, current treatment and changes in treatment, employment status, past medical history and past test results relevant to psoriatic arthritis (ESR, CRP, rheumatoid factor). Participants receive usual standard care and treatment, with no study-specific treatments.

A series of questionnaires are completed at six monthly intervals recording how psoriatic arthritis affects patients’ quality of life. These questionnaires include (PROMIS-Fatigue 8A, Dermatology Life Quality Index (DLQI), HAQ-DI, EQ-5D, HAD, Perceived Stress Scale, Patient Experience with Treatment and Self-management (PETS), Work Productivity and Activity Impairment (WPAI), Psoriatic Arthritis Impact of Disease (PSAID-12)). The following assessments will be performed at each study visit and includes assessment of swollen and tender joint (66/68), assessment of enthesitis, dactylitis and psoriasis body surface area. Study nurses will record patient global VAS, pain and fatigue, physician global assessment, results from standard laboratory tests. and change in treatment. Imaging (conventional radiographs hands and feet), will be collected at baseline and at 12 months. No further study specific imaging would be performed, but dates of other routine imaging would be collected.

At the first three study visits, 55ml (8 teaspoons) of blood and a sample of urine are taken with the intention to be used for future studies to understand aspects of psoriatic arthritis, inflammation, genetics and potential biomarker discovery. It is planned to use the biobank as the basis for future clinical research. However, such studies will be the subject of separate requests for approvals, with distinct protocols.

The study is now closed to recruitment and follow up. A summary of findings can be found on the Chief Scientist Office website https://www.cso.scot.nhs.uk/wp-content/uploads/ETM.414-Final-Report.pdf

Study contacts for further information

Ms Caron Paterson, Lead Rheumatology Project Manager
Caron.Paterson@glasgow.ac.uk

Professor Stefan Siebert, Professor of Inflammation Medicine and Rheumatology
Stefan.Siebert@glasgow.ac.uk

Immune Metabolic Associations in Psoriatic Arthritis (IMAPA)

Stratification of Biologic Therapies for RA by Pathobiology (STRAP)

Study Summary (including aims, timelines and funder):

Part of the MATURA consortium led by Queen Mary University London, the Stratification of Biologic Therapies for RA by Pathobiology (STRAP) study is investigating 3 biological therapies; Rituximab, Tocilizumab and Etanercept. The study started in November 2015 and is investigating whether the most effective drug for a specific patient can be identified by examining the joint tissue from synovial biopsies.

The aim of this study is to investigate whether the most effective choice of biologic medicine for people with RA may be guided by examining the joint tissue (synovial tissue) and, in particular, whether different levels of immune cells (called B cells) within the joint can predict response to treatment.

The ultimate aim is to provide a tailored approach to treatment decisions for people with RA, in order to maximize their potential response to biologic medicines.

Who can participate? (Inclusion/exclusion criteria)

Patients with active (DAS28 ≥ 5.1) who have failed at least 2 Disease Modifying Anti-Rheumatic Drugs (or DMARDs; including methotrexate, sulfasalazine and hydroxychloroquine), who have not previously received treatment with biologic drugs.

Glasgow started recruitment in October 2016. 11 patients have been recruited in Glasgow to date.

What does the study involve?

With your permission, you will first attend a screening visit (approximately 1 hour), which will assess your eligibility for the study in more detail, which will include:

Full medical history including medical conditions and surgical procedures, allergies, medication list, etc
Completing questionnaires
A full physical examination
Thorough examination of all your joints
Chest X-ray
Electrocardiography (ECG)
Routine blood test
Vital signs including blood pressure, pulse rate,
Urine pregnancy test if you are a woman of child-bearing age

If the tests show that you are suitable for the study and you agree to take part, you will need to agree to have a biopsy of one of your inflamed joints (usually the knee or wrist joint). This will be done by a doctor and will involve removal of small tissue samples from the lining of the joint (synovial tissue). Following this, you will be assigned to one of three treatments (etanercept, rituximab or tocilizumab), which you will first receive on the ‘baseline’ visit. Subsequently, you will attend follow-up visits every 4 weeks for a total of 24 weeks. During these visits, you will be asked to complete questionnaires and have some tests carried out.

These tests may include:

Blood tests
Additional biopsies (optional)
X-rays of your hands and feet

Are there any benefits or risks associated with taking part in this study?

A perceived risk to the patient may be that of undergoing synovial biopsy. Minimally invasive ultrasound-guided synovial biopsy has been practiced since 2007. This procedure was specifically developed to minimise discomfort and inconvenience for patients with newly developed arthritis and has been shown to be safe and well tolerated by patients, as well as generating high quality samples, including from patients in clinical remission. The three main units using this technique internationally (including Birmingham) have completed more than 1000 biopsies with no major adverse events. Audit of biopsies in Birmingham has demonstrated that >90% of patients experience nothing more than mild to moderate discomfort during the procedure, with >80% of patients likely to consent to a second biopsy.

We cannot predict the outcome of the study or participants individual responses to treatment. The three therapies participants may receive in the study are routinely used in patients with RA by clinicians as usual clinical care. They have all proven effective for the management of RA, but determining which drug is best for which patient is ultimately what the trial aims to discover; hence, responses may vary within the study as they would in standard care. An important benefit to participating is that patients will be monitored very closely by the clinical research team. They will have a dedicated research nurse who you will be able to contact directly with any questions or concerns relating to your care or participation throughout the study.

Additionally, although not of direct benefit, participation in this study will provide important new information about the feasibility and acceptability of approaches to preventing RA.

Study contacts for further information

Dr Seán Kerrigan, Glasgow Clinical Research Facility 0141 211 6800 or email: arthritisresearch@glasgow.ac.uk

Inhibition of Co-Stimulation in Rheumatoid Arthritis (ICoSRA)

Study Summary (including aims, timelines and funder):

ICoSRA is an international clinical study which utilises laboratory based, genetic patient screening and analysis to unravel immune responses in people with rheumatoid arthritis. The study aims to identify predictive markers of response to rheumatoid arthritis treatment regimes. It also will provide new information about why the disease occurs and thereby point to future possible approaches to cure.

Rheumatoid arthritis (RA) is a chronic inflammatory immune-mediated arthritis which leads to pain, swelling and destruction of joints. RA affects more than 500,000 subjects in the UK and incurs significant health and economic cost. Most patients require potent immune suppressing drugs such as methotrexate, which help reduce pain and stiffness, and protect the joints against damage. However, many patients do not respond or are unable to tolerate methotrexate. In these patients, biologic drugs such as abatacept are used to try to control the arthritis.

Abatacept is an injectable medicine designed to target and inhibit a specific molecule involved in “costimulation” of the inflammatory signal (that switches on white blood cells) that is thought to be important in RA. While abatacept has been shown to be effective in trials and clinical practice, the exact mechanism of action of abatacept in RA has not been fully elucidated. Understanding these actions is likely to inform both the use of abatacept in RA and lead to increased understanding of inflammation in humans with implications for further therapies. This six month prospective open-label study, therefore, aims to investigate the effects of inhibiting co-stimulation on a variety of important inflammatory cell types and processes in humans with RA.

This study is funded by Bristol-Myers Squibb.

Who can participate? (Inclusion/exclusion criteria)

25 participants with RA who have bad prognostic genetic markers (ACPA and HLA-DR4) and who were scheduled to receive subcutaneous abatacept as part of their standard clinical treatment will be recruited.

What does the study involve?

Consenting participants will be followed for a total of 24 weeks during which time they will have additional venous blood and urine samples taken to investigate the effects of abatacept on their immune cells and system. The primary endpoint of the study is the characterisation of the immune response following costimulatory modulation in RA patients at 12 weeks. Secondary endpoints include change in immunological response and its association with clinical outcome measures up to 24 weeks.

Are there any benefits or risks associated with taking part in this study?

We cannot predict the outcome of the study, but there is the possibility that there will be benefits to those subjects receiving the active drug, including reduction of joint symptoms and effects on the disease process that could delay or even prevent the onset of arthritis or RA. Another important benefit to participating is that you will be monitored very closely by the clinical research team. You will have a dedicated research nurse who you will be able to contact directly with any questions or concerns relating to your care or participation throughout the study.

Arthritis Prevention in the Pre-Clinical Phase of RA with Abatacept (APIPPRA)

Study Title:

Arthritis Prevention in the Pre-Clinical Phase of RA with Abatacept (APIPPRA)

Study Summary (including aims, timelines and funder):

The APIPPRA study is a UK wide 2-year study that aims to test whether medication already licensed for use in Rheumatoid Arthritis (RA) can prevent or delay the onset of the disease in those people at risk of developing RA. The lead sponsor is King’s College London and the study is supported by the NIHR.

Before people develop RA they may begin to have joint pains and have antibodies associated with RA in their blood. This trial is testing whether abatacept can help modulate the inflammatory system to prevent or delay the development of the full disease.

Who can participate? (Inclusion/exclusion criteria)

This trial is now closed to recruitment but has follow-up ongoing.

Glasgow has recruited 11 patients. The first patient was recruited in December 2015 and the last in January 2019.

What does the study involve?

The study is designed as a randomised, double blind, placebo-controlled clinical trial. This means participants will be randomly allocated (and the participants and the doctors will not know what injection they are receiving) to receive weekly injections of either abatacept or placebo (dummy) treatment for a 12-month period.

Treatment Period (Year 1): Participants will self-administer weekly injections for 12 months and will be seen every 3 months - their joints will be assessed for any sign of arthritis and bloods and urine tests will be taken. Questionnaires will be completed by the participant. An ultrasound of the joints will also be performed every six months (or earlier if it suspected RA has developed).

Participants are asked to contact the team should there be any change in, or new, symptoms between their visits – especially joint swelling, at which point they will be seen promptly and re-assessed.

If a participant does develop RA during the study, the study treatment is stopped and they are referred urgently to their local rheumatology team to begin the standard care of treatment for RA.

Follow up (Year 2): Participants will now no longer take treatment but will still be seen every 3 months (or urgently if new symptoms develop) for similar assessments to those in year 1 to monitor if there is any sign of RA developing.

Were there any benefits or risks associated with taking part in this study?

We cannot predict the outcome, but there is the possibility that there will be benefits to those subjects receiving the active drug, including reduction of joint symptoms and effects on the disease process that may delay or even prevent the onset of RA.

Another potential benefit to participating is that the participant may be monitored more closely by the clinical research team than they would usually be through the NHS. This means that if RA does develop at any point during the study there will be prompt assessment and management.

Additionally, although not of direct benefit to the participant, this study will provide important new information about the feasibility and acceptability of approaches to using treatment to prevent conditions such as RA.

There are always risks associated with taking medication. Subjects receiving active injection could potentially experience some of the following side effects:

Infections, headache, blood pressure increase, changes in liver function or white blood cell counts, diarrhoea, nausea, sore throat, fever, rashes, or injection site reactions in the skin.

In general, these are usually mild, and previous clinical trials of abatacept have shown that the medication is well tolerated in patients with early as well as established RA. Nevertheless, participants are asked to report any adverse events so that these are managed promptly.

A Study of the Safety and Effectiveness of Ustekinumab in Patients with Psoriatic Arthritis (PsA Bio)

Study Summary (including aims, timelines and funder):

This is a commercial observational study of Psoriatic Arthritis patients about to start treatment with anti-TNF or ustekinumab. It is sponsored by Janssen.

This observational study (the decision to start one of the drugs being studied is made independently of the study by the patient’s usual NHS clinician) aims to help to understand the differences in benefits and adverse events of these treatments.

The main purpose of this study is to obtain long-term data on ustekinumab usage in patients with psoriatic arthritis in real-life (as opposed to a clinical research setting) to add to the findings from the earlier run randomised clinical trials. Main aspects of focus will be to evaluate treatment retention; to characterise the profile of patients who receive these medications; and to record relevant safety outcomes, clinical effectiveness, and health economic outcomes in patients who start one of these treatments.

Who can participate? (Inclusion/exclusion criteria)

Patients with Psoriatic Arthritis who are about to start treatment with the anti-IL-12/IL-23 agent Ustekinumab or with an anti-TNF agent.

This study is now closed to new recruitment.

The first patient was recruited in Glasgow in February 2016 and the last patient in Glasgow was recruited in April 2018. 17 participants were recruited. Follow-up is ongoing.

What does the study involve?

This study involves data collection only - information on and evaluation of participant’s health and treatments. This is done at least every 6 months through assessment by a study doctor and through completion of questionnaires by participants for a total of three years. Taking part in the study will not change any treatment that participants would normally get from their doctor.

Are there any benefits or risks associated with taking part in this study?

There may not be personal benefit from taking part in this study; however, it is possible that the results of this study may help improve care of future patients with psoriatic arthritis.

There are no medical or health related risks and inconveniences of being in this study due to its observational nature. There are no additional treatments given and no additional tests performed, with the exception of fulfilling participant questionnaires.

For the risks and side effects of the drug(s) being studied, these are provided in current product information leaflets.

Biomarker Association in Skin and Synovium in Psoriatic Arthritis Study (BASSPA)

Study Summary (including aims, timelines and funder):

Psoriatic arthritis (PsA) is an inflammatory arthritis which affects up to 30% of patients with psoriasis. The relationship between the joint disease (inflammatory arthritis) and skin disease (psoriasis) is not completely understood but the immune system is involved in both aspects of the disease. Currently, there is no way of determining which treatment will be most beneficial in individual patients and treatment decisions in clinic remain based largely on "trial-and error" with no good biomarkers to support these decisions.

With the BASSPA study, we want to better understand inflammation in arthritis and psoriasis. To do this, westudy the immune cells and proteins/biomarkers in blood and urine samples, together with detailed clinical assessments. In addition, we perform biopsies of the skin and joint in a sub-group of people with PsA, so that we can study these cells and proteins in the skin and joints too.

A better understanding of inflammation in arthritis and psoriasis and how people respond to treatments can help researchers predict how people will respond to different treatments.

Primary research objective

To find disease specific biomarkers and cell types in blood, skin and the lining of joints in patients with PsA.

Secondary research objectives

To correlate these biomarkers and cell populations with clinical activity.
To assess the effect of PsA treatments on blood, skin and synovial biomarkers and cell populations.

This prospective, observational study will recruit 30 patients with PsA (and 5 controls with rheumatoid arthritis, RA) who are due to start a disease modifying drug (DMARD) or biologic as part of their standard clinical care. It will measure immune cells and proteins/biomarkers before and during treatment. Participants are followed up for 1 year.

The first participant was recruited in March 2018 and it is expected that recruitment will conclude at the end of June 2019.

The study is funded by Boehringer Ingelheim.

Who can participate? (Inclusion/exclusion criteria)

Patients with PsA (30) and RA (5) who have active disease and are due to start or change a disease modifying drug (DMARD) or biologic as part of their standard clinical care.

What does the study involve?

The study involves 5 visits in a 12-month period.

At all visits, a clinical assessment is performed, questionnaires completed, and blood tests taken. Urine samples are collected at 3 visits.

At the first visit, participants also have an ultrasound performed and X-rays of hands and feet.

A sub-group of 10 patients with PsA will undergo skin and joint biopsies at the first visit. Skin +/- joint biopsies are repeated after 3 months.

Are there any benefits or risks associated with taking part in this study?

This is an observational study with no direct benefit for the participants.

As with any invasive procedures, there are risks associated with skin and synovial biopsies. These are discussed in detail with participants who consider participation in the sub-study.

BIOlogical-Factors that Limit sustAined Remission in rhEumatoid arthritis (BIO-FLARE)

Study Summary (including aims, timelines and funder):

Rheumatoid arthritis is a relapsing and remitting autoimmune disease. The challenge that we will address is why immune-mediated inflammatory diseases (IMIDs) remit and relapse. Whilst a considerable amount is understood about factors which may contribute to development of RA and about disease mechanisms, nothing is known of the factors that trigger disease relapses (flares), converting the disease from an inactive to an active state. The underpinning mechanism(s) of flare have been difficult to study because they occur unpredictably. By studying patients who flare, we will attempt to capture signals that may determine which patients are most likely to flare, as well as understanding the biology behind the phenomenon of flare itself. This may eventually lead to future work on treatable targets in disease management. Funder: Medical Research Council

What does the study involve?

In this study, we will recruit patients in remission from RA on traditional disease modifying therapies (DMARDs), namely methotrexate, sulfasalazine, and/or hydroxychloroquine. These patients will then discontinue their DMARDs and be closely followed-up by the research team. Previous research suggests 50% will experience flare, while the remainder will remain in remission. They will have regular assessment of their disease activity (physical examination and questionnaires), along with clinical and research blood samples taken. Urine samples will be taken at each visit. If a patient in the study experiences a flare, they will have an ultrasound-guided synovial biopsy taken under local anaesthetic. Samples of blood, urine and synovium (joint lining) will be analysed for gene expression, synovial cell subtypes, molecular pathways, immune cell profiles, and antibody status.

After 6 months, if a patient does not experience a flare, they will be referred back to their usual rheumatologist and may be able to remain off of DMARDs. If a patient experiences flare at any time, they will receive steroid treatment and be referred back to their usual rheumatologist to restart their DMARDs.

Are there any benefits or risks associated with taking part in this study?

The main perceived ethical issue will be withdrawal of DMARD therapy from patients in clinical remission, although this might in fact be considered potentially beneficial for participants. DMARDs are not without adverse (side) effects, ranging from common symptoms such as nausea to less common but more serious side-effects such as bone marrow suppression, infection, and liver or lung injury. The risk of some of these problems is dependent on cumulative lifetime dosage. With this in mind, regular blood test monitoring is standard care while patients are taking these medications. These add a further inconvenience to patients, as well as additional costs to healthcare providers. Our qualitative data (submitted for publication) and feedback from patients’ engagement groups show that many patients view DMARDs as a significant burden on quality of life, and would value the opportunity of DMARD discontinuation. Minimisation of DMARDs in the setting of RA remission is supported by current RA management guidelines issued by the National Institute of Health and Care Excellence, as well as the European League Against Rheumatism

Synovial biopsy represents a further potential ethical issue. Minimally invasive ultrasound-guided synovial biopsy has been practiced since 2007. This procedure was specifically developed to minimise discomfort and inconvenience for patients with newly developed arthritis and has been shown to be safe and well tolerated by patients, as well as generating high quality samples, including from patients in clinical remission. The three main units using this technique internationally (including Birmingham) have completed more than 1000 biopsies with no major adverse events. Audit of biopsies in Birmingham has demonstrated that >90% of patients experience nothing more than mild to moderate discomfort during the procedure, with >80% of patients likely to consent to a second biopsy. Biopsy of patients in remission is optional in BIO-FLARE, and would only be considered where a sufficient synovial biopsy target is identified by ultrasound.

Offsetting these above potential issues is the fact that up to 50% of patients are likely to remain off of DMARDs for prolonged periods of time, potentially for several years. Furthermore, participants will be contributing to an important piece of research that addresses a clinically important question.

Study contacts for further information

Dr Seán Kerrigan, Glasgow Clinical Research Facility 0141 211 6800 or email: arthritisresearch@glasgow.ac.uk

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Clarity

Closed Studies

Scottish Early Rheumatoid Arthritis (SERA)

ScOttish Psoriatic arthritis Observational Study and biobank (SOPHOS)

Immune Metabolic Associations in Psoriatic Arthritis (IMAPA)

Stratification of Biologic Therapies for RA by Pathobiology (STRAP)

Inhibition of Co-Stimulation in Rheumatoid Arthritis (ICoSRA)

Arthritis Prevention in the Pre-Clinical Phase of RA with Abatacept (APIPPRA)

A Study of the Safety and Effectiveness of Ustekinumab in Patients with Psoriatic Arthritis (PsA Bio)

Biomarker Association in Skin and Synovium in Psoriatic Arthritis Study (BASSPA)

BIOlogical-Factors that Limit sustAined Remission in rhEumatoid arthritis (BIO-FLARE)