TARGET GCAT Registry

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Giant Cell Arteritis

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>Cases are patients that are prescribed tocilizumab as escalation therapy for relapsing/refractory GCA | |
| Control<br>Controls are those that are prescribed an alternative escalation therapy (not tocilizumab) for relapsing/refractory GCA. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| To describe reasons for premature discontinuation of tocilizumab | Reason for premature discontinuation of tocilizumab is captured at the follow up visits. | 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 | 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 | 0-18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tocilizumab, Giant Cell Arteritis