TARGET GCAT Registry

Giant Cell Arteritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04049071
• Other study ID #: MM05/7307
• Status: Terminated
• Start date: May 13, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: May 2021
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

Locations

Country	Name	City	State
United Kingdom	Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust	Birmingham
United Kingdom	Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	Royal Derby Hospital, University Hospital of Derby and Burton NHS Foundation Trust	Derby
United Kingdom	Ninewells Hospital and Medical School, NHS Tayside	Dundee
United Kingdom	NHS Lothian, Edinburgh	Edinburgh
United Kingdom	Inverclyde Royal Hospital, NHS Greater Glasgow & Clyde	Glasgow
United Kingdom	Royal Alexandra Hospital, NHS Greater Glasgow & Clyde	Glasgow
United Kingdom	Vale of Leven Hospital, NHS Greater Glasgow & Clyde	Glasgow
United Kingdom	Harrogate and District NHS Foundation Trust	Harrogate
United Kingdom	Airedale General Hospital, Airedale NHS Foundation Trust	Keighley
United Kingdom	Royal Lancaster & Westmorland General, University Hospitals of Morecambe Bay NHS Foundation Trust	Kendal
United Kingdom	Chapel Allerton Hospital, Leeds Teaching Hospitals NHS Foundation Trust	Leeds
United Kingdom	Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust	Leicester
United Kingdom	Aintree University Hospital, Aintree University Hospital NHS Foundation Trust	Liverpool
United Kingdom	Royal Glamorgan Hospital, Cwm Taf University Health Board	Llantrisant
United Kingdom	Kings College Hospital NHS Foundation Trust	London
United Kingdom	Royal Free Hospital, Royal Free London NHS Foundation Trust	London
United Kingdom	University College London NHS Foundation Trust	London
United Kingdom	Luton and Dunstable Hospital, The Luton and Dunstable Hospitals NHS Foundation Trust	Luton
United Kingdom	Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust	Manchester
United Kingdom	The Freeman Hospital, The Newcastle-upon-Tyne Hospitals NHS Foundation Trust	Newcastle Upon Tyne
United Kingdom	Northampton General Hospital	Northampton
United Kingdom	Norfolk and Norwich University Hospital NHS Foundation Trust	Norwich
United Kingdom	Queens Medical Centre, Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Oxford Nuffield Orthopaedic Centre, Oxford University Hospitals NHS Foundation Trust	Oxford
United Kingdom	Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust	Preston
United Kingdom	Southend University Hospital NHS Foundation Trust	Southend-on-Sea
United Kingdom	Lister Hospital, East and North Hertfordshire NHS Trust	Stevenage
United Kingdom	Torbay Hospital, Torbay and South Devon NHS Foundation Trust	Torquay
United Kingdom	Royal Cornwall Hospitals NHS Foundation Trust	Truro
United Kingdom	Dewsbury & District Hospital, Mid Yorkshire Hospitals NHS Trust	Wakefield
United Kingdom	Pinderfields Hospital, Mid Yorkshire Hospitals NHS Trust	Wakefield
United Kingdom	University Hospital Wishaw, NHS Lanarkshire	Wishaw
United Kingdom	York Teaching Hospital NHS Foundation Trust	York

Sponsors (3)

Lead Sponsor	Collaborator
University of Leeds	Hoffmann-La Roche, University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the proportion of eligible patients who achieve sustained partial or complete remission 6 months after the start of tocilizumab	Data on disease features and lab tests collected at 6 month, compared with that collected at baseline	6 months
Secondary	To determine the proportion of eligible patients who achieve a sustained complete remission 6 months after the start of tocilizumab	Data on disease features and lab tests collected at 6 month, compared with that collected at baseline	6 months
Secondary	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.	Collection of safety data throughout study (non serious adverse events, serious adverse events, adverse events of special interest, special situations, notification of death)	18 months
Secondary	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.	All data collected throughout the study period	0-18 months
Secondary	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	Data on disease features and lab tests collected at month 12 and 18 and compared with that collected at baseline and month 6	0-18 months
Secondary	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	Data collected on disease features, inflammatory markers and vital signs.	0-12 months
Secondary	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	Data collected on disease features and event reporting as appropriate (serious adverse events & non-serious adverse events).	0-12 months
Secondary	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	Data collected on lab results such as HbA1c and medication taken including the dose, reason for changes in dose or discontinuation, documentation of any events relating to drug toxicity.	0-12 months
Secondary	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	Data on glucocorticoid collected throughout study including dose changes & date of change	0-18 months
Secondary	To describe reasons for premature discontinuation of tocilizumab	Reason for premature discontinuation of tocilizumab is captured at the follow up visits.	0-18 months
Secondary	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	Data collected throughout study on features associated with glucocorticoid toxicity such as those listed within the title	0-18 months
Secondary	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	Keeping a record of those who have been agreed to be contacted for similar studies in the randomised controlled trials	0-18 months