The TARGET Consortium
The GCAT Registry
What is the GCAT Registry?
The GCAT (Giant Cell Arteritis Tocilizumab) Registry is a post-marketing surveillance registry to study the effectiveness, safety and prescribing habits of tocilizumab for the treatment of GCA in the UK National Health Service. It is nested within the existing structure of the established UK GCA Consortium (Leeds; 05/Q1108/28) and UKIVAS (Oxford;10/H1102/77) studies. The GCAT Registry is supported by Roche Products Limited as an Investigator Initiated Study and will commence on 1st March 2019 for a period of three years (36 months).
Why is the GCAT Registry important?
Tocilizumab is now licensed in the US and EU for the prevention of relapses in giant cell arteritis (GCA) following the successful clinical trial GiACTA. However, because this is the first introduction of IL-6 pathway inhibition into clinical care of GCA, there remain important clinical questions regarding the effectiveness and safety of this therapy in routine clinical practice. Post-marketing surveillance is essential in order to provide precise and generalizable estimates of risks and benefits of this treatment. In particular, it is not known if tocilizumab affects the incidence of long-term complications of GCA, such as visual loss, large-vessel aneurysm or stenosis.
In the UK, a commissioning decision by the National Institute of Health and Care Excellence (NICE) was announced (on 18 April 2018), allowing the use of tocilizumab in GCA. This decision will be reviewed after a specified time-period (anticipated to be 2021) and is likely to be dependent on real-life clinical outcome data, including data relevant to health economic analyses such as resource use and health-related quality of life. Unique to the UK, is the stipulation that tocilizumab can be prescribed for no more than one year and only once for each patient.
On the 10th September 2018, the Scottish Medicines Consortium (SMC) completed its assessment of tocilizumab for the treatment of GCA – taking into account of views from a Patient and Clinician Engagement (PACE) meeting and the results of the GiACTA trial. They provided advice to the NHS Boards and Area Drug and Therapeutic Committees on its use in NHS Scotland. This document can be found here.
What is the main aim of the GCAT Registry?
The main aim is to assess the effectiveness and safety of tocilizumab in controlling refractory or relapsing GCA in patients who require escalation therapy to reach sustained remission. The primary objective is to determine the proportion of eligible patients who achieve sustained partial or complete remission 6 months after the start of tocilizumab.
What is the study design?
The GCAT Registry is a matched observational cohort study, nested within the UK GCA Consortium cohort, using the established UKIVAS data collection systems. Participants will be invited to consent to the collection of clinical data related to their diagnosis of GCA, investigations, treatment and outcomes.
How do patients get recruited into the GCAT Registry?
Patients will be recruited if they have been diagnosed with GCA and are either experiencing a relapse of disease or have refractory disease, and have either started, or are about to commence, escalation therapy as part of standard care. Cases will be patients who are prescribed tocilizumab, and Controls will be patients who have not been prescribed tocilizumab but have been prescribed a different type of medication to treat their GCA. Patients must fulfil the NHS England criteria for refractory or relapsing disease. Patients will be informed about the study by their routine clinical care team when they are identified as having refractory or relapsing disease and referred to a regional Specialist Commissioning Rheumatology or Ophthalmology MDT for consideration of treatment escalation as part of standard clinical care. If they agree to participate, a member of the research team will contact them by letter of invitation or by telephone.
What type of information will be collected from patients taking part in the GCAT Registry?
When patients are recruited they will be asked about their age, sex and ethnicity and use of tobacco products. We will gather information about when they were diagnosed with GCA and the results of tests conducted to diagnose them and to assess their treatment. We will collect information about what drugs they have taken in the past and what drugs they are taking at the time of enrolment into the Registry, and we will complete the Birmingham Vasculitis Activity Score, (BVAS) and Vasculitis Damage Index (VDI) questionnaires. In addition, all data relevant to fulfilment of NICE guidance for NHS England tocilizumab prescribing will be recorded. Finally, we will explore the reasons the patients have starting taking tocilizumab (or other strategy) to treat their GCA. Each patient will have four study visits: before treatment with tocilizumab (baseline); at 6 and 12 months of treatment 6 months after treatment with tocilizumab has been withdrawn. in the case of participants who are not taking tocilizumab (Controls) study visits will be at the point of entry to the study, and at 6, 12 and 18 months.
To meet the GCAT team and get in touch about the Registry please follow this link.