A Randomized Multi-Center, Double-Blind, Placebo-Controlled Study of a New Modified-Release Tablet Formulation of Prednisone (Lodotra®) in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 350
- 试验地点
- 52
- 主要终点
- ACR 20 Response Rate at Visit 4
研究概览
简要总结
The purpose of the study is to compare the safety and efficacy, with regards to the signs and symptoms, of MR prednisone (Lodotra®) versus placebo in combination with standard Disease Modifying Anti-Rheumatic Drug (DMARD) treatment in patients with active rheumatoid arthritis.
详细描述
Study with completed results acquired from Horizon in 2024.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented history of RA in agreement with ACR criteria
- •DMARD treatment for RA greater than or equal to 6 months, with a stable dose greater than or equal to 6 weeks prior to screening visit
- •Duration of morning stiffness greater than or equal to 45 minutes
- •greater than or equal to 4 swollen joints (out of 28)
- •greater than or equal to 4 tender joints (out of 28)
排除标准
- •Suffering from another disease, which requires glucocorticoid treatment during the study period
- •Synovectomy within 4 months prior to study start
- •Use of glucocorticoids:
- •Continued use of systemic glucocorticoids within 4 weeks prior to screening visit
- •Intermittent use of glucocorticoids within 2 weeks prior to screening visit.
- •Joint injections within 6 weeks prior to screening visit
- •Topical glucocorticoids must be stopped at screening visit
- •Use of biologicals such as: tumor necrosis factor α (TNFα) inhibitors and other compounds within 5 serum half lives prior to screening visit
- •Pregnancy or nursing
研究组 & 干预措施
NP01
Modified Release (MR) prednisone 5 mg
干预措施: MR prednisone (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
ACR 20 Response Rate at Visit 4
时间窗: Week 12
Responders were defined as patients whose improvement from baseline to Visit 4 (Week 12) fulfilled all 3 of the following criteria: * \> 20% reduction in the tender joint count (0-28) * \> 20% reduction in the swollen joint count (0-28) * \> 20% reduction in 3 out of the 5 following additional measures: * Patient's assessment of pain * Patient's global assessment of disease activity * Physician's global assessment of disease activity * Functional Disability Index of the Health Assessment Questionnaire * C-reactive protein or erythrocyte sedimentation rate
次要结局
- Relative Reduction of Morning Stiffness(Week 12)