TARGET GCAT Registry

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04049071

Enrollment

Registered

2019-08-07

Start date

2019-05-13

Completion date

2020-06-30

Last updated

2021-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Cell Arteritis

Keywords

Tocilizumab, Giant Cell Arteritis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
To determine the proportion of eligible patients who achieve sustained partial or complete remission 6 months after the start of tocilizumab	6 months	Data on disease features and lab tests collected at 6 month, compared with that collected at baseline

Secondary

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

Countries

United Kingdom

Outcome results