The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study Comparing the Cost-effectiveness and Safety of Additional Low-dose Glucocorticoid in Treatment Strategies for Elderly Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 451
- 试验地点
- 28
- 主要终点
- Signs and Symptoms: Mean DAS28 Post Baseline
研究概览
简要总结
Comparing the cost-effectiveness and safety of additional low-dose glucocorticoid in treatment strategies for elderly patients with rheumatoid arthritis:
The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study (GLORIA)
详细描述
Rationale: Rheumatoid arthritis (RA) is a condition with high impact both on the individual and society. In the context of comparing the effectiveness of existing healthcare interventions in the elderly, RA is a condition highly relevant to the community since it has a strongly negative impact on the quality of life of the individual, is particularly frequent in the elderly, and is associated with significant costs. RA management remains challenging: there is an urgent unmet medical and societal need for improved treatment strategies that are effective, safe and affordable. Evidence based information on the glucocorticoid (GC) harm/benefit balance will have a high impact on RA treatment strategies and on treatment strategies for the many other inflammatory disorders for which GCs are considered. The Glucocorticoid Low-dose Outcome in RheumatoId Arthritis Study (GLORIA) is a 5-year project funded by the European Commission under the Horizon 2020 Program, designed to address these needs.
Objective: The primary objectives of the GLORIA project are twofold:
- To assess the effectiveness, safety and cost-effectiveness of low-dose GC therapy (5 mg/day) compared to placebo given for two years as co-treatment for elderly RA patients (≥ 65 years) in a pragmatic randomized trial;
- To assess study medication adherence through a medication packaging solution, and test the effectiveness of smart device technology to improve adherence.
Other objectives of the GLORIA project are: to deliver an outcome prediction model for individual patient outcome, to tailor treatment strategies for elderly RA patients with comorbidities; and deliver data to support:
- better guidelines on RA treatment in the elderly;
- more accurate information for elderly RA patients, their physicians and researchers;
- improved strategies for trial design and conduct in the elderly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
prednisolone
prednisolone 5 mg per day
干预措施: Prednisolone (Drug)
placebo
placebo capsules once per day
干预措施: Placebo (Drug)
结局指标
主要结局
Signs and Symptoms: Mean DAS28 Post Baseline
时间窗: 0,3,6,12,18,24 months
mean of the DAS28 (disease activity score-28 joints) post baseline. Range 0-8, higher scores mean more disease activity. See link in reference list.
The Total Number of Patients Experiencing at Least One Adverse Event (AE) of Special Interest (AESI)
时间窗: 24 months
AESI: (a serious adverse event \[SAE\], or an AE on a prespecified list of clinically relevant AEs commonly associated with the disease and glucocorticoid use
次要结局
- Joint Damage Progression(0, 24 months)
研究者
Prof. dr. M. Boers
Professor
Amsterdam UMC, location VUmc