NCT00110942已完成2 期
A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Systemic AMG 108 in Subjects With Osteoarthritis (OA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 160
- 主要终点
- Change in WOMAC pain score
研究概览
简要总结
The purpose of this study is to evaluate the clinical benefit (change in Western Ontario and McMaster University Osteoarthritis Index [WOMAC] pain score) of AMG 108 (300 mg subcutaneously [SC] every 4 weeks) in subjects with OA.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with knee OA as determined by American College of Rheumatology (ACR) criteria
- •Pain defined by a level of greater than or equal to 30 mm on a 100 mm Visual Analogue Scale (VAS)
- •If currently taking any over the counter nutritional supplements, must be on stable doses for greater than 2 months prior to screening
- •If utilizing physical therapy, biomechanical devices or orthotic support, must have been using treatment or device for greater than or equal to 2 months prior to screening
- •If currently or previously taking any non-prescribed supplement (e.g., glucosamine or chondroitin sulphate, shark cartilage, diacerein, soya extract, etc.) must be on stable doses for at least 2 months prior to screening
- •If currently taking nonsteroidal anti-inflammatory drugs (NSAIDs), must be on stable doses for at least 2 months prior to screening
- •Able to discontinue NSAIDs at least 5 half-lives (approximately 3 days) prior to Day 1
- •Radiographic evidence of tibio-femoral compartment knee OA within 12 months of screening
- •Signed written informed consent
排除标准
- •Malignancy within the previous 5 years, except for basal cell or in situ cancer
- •Significant hematologic disease - Active infection or history of recurrent or chronic infections
- •Known diagnosis of HIV, hepatitis B, or hepatitis C infection
- •Uncontrolled diabetes or cardiovascular disease and hypertension
- •Inflammatory arthropathy including secondary OA
- •Isolated OA of the patellofemoral joint (bi or tri-compartmental involvement are not exclusions)
- •End-stage ("bone-on-bone") OA (Kellgren Lawrence score of 4)
- •OA of the hip ipsilateral to the index knee - Total white cell count less than 2.0 x 10^9/L and/or platelet count less than 100 x 10^9/L observed within 1 month preceding screening
- •Prior intra-articular (IA) injection of anakinra or experimental interleukin-1 (IL-1) inhibitor therapy - Concurrent treatment with SC anakinra
- •Concurrent or recent (less than or equal to 1 month) use of experimental therapy
- •Prior IA corticosteroid injection within 1 month of study
- •Prior viscosupplement therapy within 3 months of study
- •Contraindication(s) to IA injections
- •Subjects who are pregnant or breast-feeding, or plan to become pregnant during the study
- •Subject is not using adequate contraception
- •Known allergy to E coli-derived products
- •Unable to understand informed consent
- •Concerns regarding subject's compliance with the protocol procedures
- •Subject will not be available for follow-up assessment
- •Active substance abuse
研究组 & 干预措施
Minor sub-study AMG 108
Active Comparator
N = 15
干预措施: Systemic AMG 108 (Drug)
Minor sub-study placebo
Placebo Comparator
N = 15
干预措施: Placebo (Other)
Main sub-study AMG 108
Active Comparator
N = 73
干预措施: Systemic AMG 108 (Drug)
Main sub-study placebo
Placebo Comparator
N = 73
干预措施: Placebo (Other)
结局指标
主要结局
Change in WOMAC pain score
时间窗: Week 6
次要结局
- Change in WOMAC pain score(Week 12)
- Change in WOMAC composite score and function and stiffness index scores(Weeks 6 and 12)
- Achieving 50% or more improvement from Day 1 in the WOMAC(Weeks 6 and 12)
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