A Randomized, Double-blind, Active-controlled Study of Canakinumab Prefilled Syringes or Reconstituted Lyophilizate Versus Triamcinolone Acetonide for Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 397
- 试验地点
- 1
- 主要终点
- Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups
研究概览
简要总结
This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.
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
- 18 Years 至 85 Years（Adult, 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
Canakinumab, pre-filled syringes (PFS)
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
干预措施: Canakinumab pre-filled syringe (Drug)
Canakinumab, pre-filled syringes (PFS)
Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
干预措施: Placebo (Drug)
Canakinumab, lyophilizate (LYO)
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized powder and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
干预措施: Canakinumab lyophilized powder (Drug)
Canakinumab, lyophilizate (LYO)
The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized powder and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
干预措施: Placebo (Drug)
Triamcinolone Acetonide
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
干预措施: Triamcinolone Acetonide (Drug)
Triamcinolone Acetonide
The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups
时间窗: 72 hours post dose
The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.
次要结局
- Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups(72 hours post dose)
- Patient's Assessment of Pain Intensity on a 0-100mm VAS(14 days)
- Patient's Assessment of Pain Intensity on a 5-point Likert Scale(72 hours)
- Number of Patients With at Least One New Gouty Arthritis Flare After Baseline(12 weeks)
- Time to the First New Gouty Arthritis Flare(12 weeks)
- Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS(14 days)
- Time to Resolution of Gouty Arthritis Flare as Reported by Patient(14 days)
- Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale(72 hours)
- Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale(72 hours)
- Physician's Assessment of Tenderness(72 hours)
- Physician's Assessment of Swelling(72 hours)
- Physician's Assessment of Erythema(72 hours)
- Physician's Assessment of Range of Motion of the Most Affected Joint(72 hours)
- Time to First Rescue Medication Intake(14 days)
- Proportion of Patients With Rescue Medication Intake(12 weeks)
- Amount of Rescue Medication Taken (mg)(14 days)
- C-reactive Protein Level(72 hours)