A New Timed-Release Tablet Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis- A Randomized, Multi-Centre, Double-Blind, Active Controlled Study With Open Extension on the New Drug Only
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Relative Change From Baseline in Duration of Morning Stiffness at Week 12
研究概览
简要总结
The objective of this study is to investigate if low doses of prednisone MR formulation, given at night and, with active drug release at 2 am, are more effective in controlling joint stiffness, and other disease symptoms of rheumatoid arthritis than standard IR prednisone given in the morning.
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
- •Active disease (inflammatory signs, erythrocyte sedimentation rate [ESR], C-reactive protein [CRP])
- •Stable condition
- •Stable basic treatments
- •Morning stiffness on previous treatment with standard prednisone (below or equal to 10 mg per day) greater than or equal to (>/=) 45 minutes
排除标准
- •All contra-indications for glucocorticoids
- •Pregnancy
- •Concomitant treatment with biologics
- •Intra-articular injections or synovectomy within the previous 4 months
研究组 & 干预措施
MR Prednisone
Participants will receive MR prednisone at bed time and placebo matching to IR prednisone in the morning. Total duration of double blind treatment will be 12 weeks.
干预措施: MR Prednisone (Drug)
MR Prednisone
Participants will receive MR prednisone at bed time and placebo matching to IR prednisone in the morning. Total duration of double blind treatment will be 12 weeks.
干预措施: Placebo - IR Prednisone (Drug)
IR Prednisone
Participants will receive IR prednisone in the morning and placebo matching to MR prednisone at bed time. Total duration of double blind treatment will be 12 weeks.
干预措施: IR Prednisone (Drug)
IR Prednisone
Participants will receive IR prednisone in the morning and placebo matching to MR prednisone at bed time. Total duration of double blind treatment will be 12 weeks.
干预措施: Placebo - MR Prednisone (Drug)
结局指标
主要结局
Relative Change From Baseline in Duration of Morning Stiffness at Week 12
时间窗: Baseline, Week 12
Duration of morning stiffness was defined as the time elapsed (in minutes) between the time of usual awakening (even if not in the morning) and the time the participant was able to resume normal activities without stiffness. Relative (percent) change = (\[value at Week 12 minus value at Baseline\] divided by \[value at baseline\]) multiplied by 100.
次要结局
- Percentage of Participants With Recurrence of Joint Stiffness at Week 12(Week 12)
- Relative Change From Baseline in 28-Joint Disease Activity Score (DAS28) at Week 12(Baseline, Week 12)
- Relative Change From Baseline in Pain Intensity at Week 12(Baseline, Week 12)
- Relative Change From Baseline in Quality of Sleep at Week 12(Baseline, Week 12)
- Relative Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12(Baseline, Week 12)
- Relative Change From Baseline in Short-Form 36 (SF36) Mental Component Score (MCS) at Week 12(Baseline, Week 12)
- Relative Change From Baseline in SF36 Physical Component Score (PCS) at Week 12(Baseline, Week 12)