OPEN-LABEL, MULTIPLE-DOSE STUDY OF THE SAFETY AND EFFICACY OF RN624 IN ADULTS WITH PAIN DUE TO OSTEOARTHRITIS OF THE KNEE.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 287
- 试验地点
- 36
- 主要终点
- Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
Study RN624-CL007 is planned to be an open-label protocol to enroll subjects who have previously participated in Study No. RN624-CL006. In this study, subjects will receive RN624 on an open-label basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in Study RN624-CL006
排除标准
- •The occurrence of any adverse event or condition during the controlled studies that, in the opinion of the Investigator, should exclude the subject from participating in the open-label extension
- •Pregnant or lactating female subjects or subjects who do not agree to use an appropriate form of birth control throughout the study and for 3 months after completing the study
研究组 & 干预措施
1
干预措施: RN624 (PF-04383119) (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to 12 weeks after last dose of study drug
AE: any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 12 weeks after last dose that were absent before treatment in this study or that worsened relative to pretreatment state. AEs included both SAEs and non-serious adverse events.
次要结局
- Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72(A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72)
- Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72(A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72)
- Change From A4091008 (NCT00394563) Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72(A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72)
- Change From A4091008 (NCT00394563) Baseline Visual Analog Scale (VAS) for Pain Intensity in the Index Knee at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72(A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72)
- Change From A4091008 (NCT00394563) Baseline in Participant Global Assessment Score at Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72(A4091008: Baseline, A4091009: Week 0, 4, 8, 16, 24, 32, 40, 48, 56, 64, 72)
- Number of Participants With Response to Participant Satisfaction Questionnaire(A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72)
- Change From A4091009 (NCT00399490) Baseline in 36-Item Short-Form Health Survey (SF-36) at Week 4, 8, 16, 24, 32, 40, 48, 56, 64 and 72(A4091009: Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64, 72)
- Percentage of Participants Who Discontinued the Study(A4091009: Baseline up to 12 weeks after last dose of study drug)
- Median Time in Study A4091009(A4091009: Baseline up to 12 weeks after last dose of study drug)