A 24-week Open-label, Multicenter, Follow-up and Extension Study to CACZ885H2251, to Assess Safety, Tolerability and Efficacy of Canakinumab (ACZ885) in Patients With Gout Who Were Given Canakinumab at the Time of Gout Flare
概览
- 阶段
- 2 期
- 干预措施
- Canakinumab
- 疾病 / 适应症
- Gouty Arthritis
- 发起方
- Novartis Pharmaceuticals
- 入组人数
- 341
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events and Serious Adverse Events
- 状态
- 已完成
- 最后更新
- 4年前
概览
简要总结
This 24-week open-label extension study is designed to provide additional long-term safety data up to a total of 1-year for patients rolling over from the core study, and to collect further efficacy and tolerability data for all the patients, irrespective whether they have an acute flare of gout or not. Patients will be treated on demand with canakinumab (ACZ885) in this extension study.
研究者
入排标准
入选标准
- •Patients who completed the core study CACZ885H
- •A patient is defined as completing the core study if he/she completed the study up to and including the last visit (Visit 9).
- •Patients who have signed a written informed consent before any trial procedure is performed.
排除标准
- •Patients for whom continuation in the extension 1 is not considered appropriate by the treating physician.
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive pregnancy test (serum or urine).
- •Female patients who were physiologically capable of becoming pregnant, unless they were:
- •Female patients whose career, lifestyle, or sexual orientation precluded intercourse with a male partner.
- •Female patients whose partners had been sterilized by vasectomy or other means.
- •Using an acceptable method of contraception with a failure rate (Pearl Index (PI)) \<
- •Reliable contraception had to be maintained throughout the study and for 2 months after study drug discontinuation.
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
canakinumab
干预措施: Canakinumab
结局指标
主要结局
Number of Participants With Adverse Events and Serious Adverse Events
时间窗: From start of study up to study completion (up to 14 months)
Adverse events (AEs) were defined as any unfavourable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalisation, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards
次要结局
- Difference Change From Baseline in Participant's Gout Pain During First Flare(Baseline and Day 7)
- Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category(24 weeks)
- Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group(24 weeks)
- Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category(24 weeks)
- Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group(24 weeks)