TARGET GCAT Registry

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

Time frame: 6 months

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)

Time frame: 18 months

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

Time frame: 0-18 months

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

Time frame: 0-18 months

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.

Time frame: 0-12 months

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).

Time frame: 0-12 months

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.

Time frame: 0-12 months

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

Time frame: 0-18 months

To describe reasons for premature discontinuation of tocilizumab

Reason for premature discontinuation of tocilizumab is captured at the follow up visits.

Time frame: 0-18 months

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

Time frame: 0-18 months

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

Time frame: 0-18 months