NCT04086745已完成4 期
A Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid Arthritis
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,050
- 试验地点
- 238
- 主要终点
- Time from First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE)
研究概览
简要总结
This post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (TNF) inhibitors with respect to venous thromboembolic events (VTEs) when given to participants with rheumatoid arthritis (RA).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have at least one of the following characteristics:
- •Documented evidence of a VTE prior to this study
- •At least 60 years of age
- •A body mass index (BMI) greater than or equal to 30 kilograms per meter squared (kg/m²), or
- •Age 50 to less than 60 years and BMI 25 to less than 30 kg/m²
- •Participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drug (DMARD) (synthetic or biologic)
排除标准
- •Participant must not have prior use of a Janus kinase (JAK) inhibitor or have received more than 1 prior TNF inhibitor that was:
- •discontinued for lack or loss of efficacy for RA, or
- •discontinued for intolerance (AE) when used for any indication
- •Participants must not be pregnant or breastfeeding
- •Participants must not have had more than one VTE
- •Participants must not have cancer
- •Participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness
- •Participants must not have had a live vaccine within four weeks of study start
- •Participants must not have participated in any other clinical trial within four weeks of study start
- •Participants must not have a history of IV drug use, other illicit drug abuse, or chronic alcohol abuse in the past year
结局指标
主要结局
Time from First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE)
时间窗: Baseline through Study Completion (Approximately 5.5 Years)
Time from First Dose of Study Treatment to First Event of VTE
Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Combined Baricitinib Dose Versus TNF Inhibitor]
时间窗: From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants)
Time from first dose of study treatment to first event of VTE was evaluated using hazard ratio as the measure of treatment effect, estimated from Cox proportional hazards regression model. The analysis was based on pooled data from studies JAJA (NCT03915964) and JAJD (NCT04086745) and was stratified by study, with treatment group and randomization stratification factors (VTE history, age/Body Mass Index (BMI) combination, prior inadequate response or intolerance to a TNF inhibitor, and geographic region) as explanatory variables.
次要结局
- Time from First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE)(Baseline through Study Completion (Approximately 5.5 Years))
- Time from First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE)(Baseline through Study Completion (Approximately 5.5 Years))
- Time from First Dose of Study Treatment to First Malignancy (excluding nonmelanoma skin cancer [NMSC])(Baseline through Study Completion (Approximately 5.5 Years))
- Time from First Dose of Study Treatment to First Opportunistic Infection(Baseline through Study Completion (Approximately 5.5 Years))
- Time from First Dose of Study Treatment to First Serious Infection(Baseline through Study Completion (Approximately 5.5 Years))
- Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Event of Venous Thromboembolism (VTE) [Individual Baricitinib Dose Versus TNF Inhibitor](From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants))
- Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Arterial Thromboembolic Event (ATE) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor](From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants))
- Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Major Adverse Cerebro-Cardiovascular Event (MACE) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor](From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants))
- Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Malignancy (Excluding Nonmelanoma Skin Cancer [NMSC]) [Combined and Individual Baricitinib Dose Versus TNF Inhibitor](From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants))
- Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Opportunistic Infection [Combined and Individual Baricitinib Dose Versus TNF Inhibitor](From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants))
- Pooled JAJA and JAJD: Time From First Dose of Study Treatment to First Serious Infection [Combined and Individual Baricitinib Dose Versus TNF Inhibitor](From the first dose of study treatment up to 30 days after the last dose or the last study visit, whichever occurs first (approximately up to 6.1 years for JAJA and 5.3 years for JAJD participants))
研究者
研究点 (238)
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