Clinical trial NCT04049071: TARGET GCAT Registry
Official title: Proposal for Establishment of a UK Post-marketing Surveillance Registry to Study the Effectiveness, Safety and Prescribing Habits of Tocilizumab for the Treatment of Giant Cell Arteritis in the UK National Health Service, Nested Within the Existing Structure of the UK GCA Consortium and UKIVAS Studies
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Giant Cell Arteritis
Keywords: Tocilizumab
Giant Cell Arteritis
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: Hoffmann-La Roche
First posted: 2019-08-07
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 500 patients prescribed tocilizumab for GCA within the NHS and 500 age-, sex- and centre-matched controls.

Brief summary: A longitudinal post-marketing surveillance registry nested within the UK GCA Consortium that assesses the effectiveness and safety of tocilizumab in controlling refractory or relapsing forms of GCA in patients who require escalation of therapy to reach sustained remission. Half the patients recruited will have been prescribed tocilizumab (cases) and the other half will be prescribed alternative therapies (controls).

There are four study visits over 18 months: baseline, 6 months, 12 months and 18 months. At each visit data is collected on demographics; diagnosis and investigations; previous and concomitant medications; medical history; co-morbidities, vital signs; smoking and alcohol; disease activity and damage; routine laboratory tests; reason for starting escalation therapy. Safety data is collected on an ongoing basis.


Eligibility criteria: Inclusion Criteria:

* Patient must have a diagnosis of GCA and be eligible for the UK GCA Consortium study
* Willing and able to consent
* Have refractory or relapsing GCA as defined by the NHS England commissioning statement for tocilizumab.
* Require treatment escalation

Primary outcomes:
measure: To determine the proportion of eligible patients who achieve sustained partial or complete remission 6 months after the start of tocilizumab
timeFrame: 6 months
Secondary outcomes:
measure: To determine the proportion of eligible patients who achieve a sustained complete remission 6 months after the start of tocilizumab
timeFrame: 6 months
measure: To assess the safety (event reporting) and effectiveness (in terms of prevention of relapse) of tocilizumab compared to other strategies for refractory/relapsing disease in patients with GCA who require escalation therapy.
timeFrame: 18 months
measure: To compare characteristics (demographics, disease severity, risk factors for steroid toxicity, contraindications to tocilizumab, concomitant medications) of real-world patients prescribed tocilizumab to clinical trial populations.
timeFrame: 0-18 months
measure: To describe relapse rates in patients with GCA treated with tocilizumab at treatment completion (usually 12 months in the UK) and 6 months following discontinuation of tocilizumab
timeFrame: 0-18 months
measure: To describe disease activity during the first 6 and 12 months following the start of tocilizumab, compared to other treatment strategies for refractory/relapsing disease
timeFrame: 0-12 months
measure: To describe ischaemic complications during the first 6 and 12 months following the start of tocilizumab, compared to other treatment strategies for refractory/relapsing disease
timeFrame: 0-12 months
measure: To describe drug related toxicity during the first 6 and 12 months following the start of tocilizumab, compared to other treatment strategies for refractory/relapsing disease
timeFrame: 0-12 months
measure: To describe patterns of glucocorticoid dosing, including estimated cumulative dose & time to discontinuation of glucocorticoids, in patients with GCA & treated with tocilizumab, compared to other treatment strategies for refractory/relapsing disease
timeFrame: 0-18 months
measure: To describe reasons for premature discontinuation of tocilizumab
timeFrame: 0-18 months
measure: To estimate the prevalence of glucocorticoid toxicity (e.g. weight gain, fracture, diabetes, infection, or new psychiatric diagnosis) in patients with GCA who are treated with tocilizumab, compared to other strategies for refractory/relapsing disease
timeFrame: 0-18 months
measure: To invite patients who agree to take part in the current study to consent to being approached to participate in future related studies of their condition, including randomised controlled trials
timeFrame: 0-18 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
city: Derby
country: United Kingdom
facility: Royal Derby Hospital, University Hospital of Derby and Burton NHS Foundation Trust
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School, NHS Tayside
city: Edinburgh
country: United Kingdom
facility: NHS Lothian, Edinburgh
city: Glasgow
country: United Kingdom
facility: Inverclyde Royal Hospital, NHS Greater Glasgow & Clyde
city: Glasgow
country: United Kingdom
facility: Royal Alexandra Hospital, NHS Greater Glasgow & Clyde
city: Glasgow
country: United Kingdom
facility: Vale of Leven Hospital, NHS Greater Glasgow & Clyde
city: Harrogate
country: United Kingdom
facility: Harrogate and District NHS Foundation Trust
city: Keighley
country: United Kingdom
facility: Airedale General Hospital, Airedale NHS Foundation Trust
city: Kendal
country: United Kingdom
facility: Royal Lancaster & Westmorland General, University Hospitals of Morecambe Bay NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Foundation Trust
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust
city: Liverpool
country: United Kingdom
facility: Aintree University Hospital, Aintree University Hospital NHS Foundation Trust
city: Llantrisant
country: United Kingdom
facility: Royal Glamorgan Hospital, Cwm Taf University Health Board
city: London
country: United Kingdom
facility: Kings College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Free Hospital, Royal Free London NHS Foundation Trust
city: London
country: United Kingdom
facility: University College London NHS Foundation Trust
city: Luton
country: United Kingdom
facility: Luton and Dunstable Hospital, The Luton and Dunstable Hospitals NHS Foundation Trust
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust
city: Newcastle Upon Tyne
country: United Kingdom
facility: The Freeman Hospital, The Newcastle-upon-Tyne Hospitals NHS Foundation Trust
city: Northampton
country: United Kingdom
facility: Northampton General Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Queens Medical Centre, Nottingham University Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust
city: Preston
country: United Kingdom
facility: Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust
city: Southend-on-Sea
country: United Kingdom
facility: Southend University Hospital NHS Foundation Trust
city: Stevenage
country: United Kingdom
facility: Lister Hospital, East and North Hertfordshire NHS Trust
city: Torquay
country: United Kingdom
facility: Torbay Hospital, Torbay and South Devon NHS Foundation Trust
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Foundation Trust
city: Wakefield
country: United Kingdom
facility: Dewsbury & District Hospital, Mid Yorkshire Hospitals NHS Trust
city: Wakefield
country: United Kingdom
facility: Pinderfields Hospital, Mid Yorkshire Hospitals NHS Trust
city: Wishaw
country: United Kingdom
facility: University Hospital Wishaw, NHS Lanarkshire
city: York
country: United Kingdom
facility: York Teaching Hospital NHS Foundation Trust
Study officials:
affiliation: University of Leeds
name: Ann Morgan
role: PRINCIPAL_INVESTIGATOR
References: