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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 34
- 主要终点
- To determine the proportion of eligible patients who achieve sustained partial or complete remission 6 months after the start of tocilizumab
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
To determine the proportion of eligible patients who achieve sustained partial or complete remission 6 months after the start of tocilizumab
时间窗: 6 months
Data on disease features and lab tests collected at 6 month, compared with that collected at baseline
次要结局
- 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)
- 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)
- 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)
- 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)
- 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)
- To determine the proportion of eligible patients who achieve a sustained complete remission 6 months after the start of tocilizumab(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.(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.(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(0-12 months)
- To describe reasons for premature discontinuation of tocilizumab(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(0-18 months)
研究者
Ann Morgan
Professor of Molecular Rheumatology and Honorary Consultant Rheumatologist
University of Leeds