A PHASE 3, MULTICENTER, RANDOMIZED, LONG TERM STUDY OF THE SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
An evaluation of the long term safety of tanezumab when administered by subcutaneous injection every 8 weeks for up to 64 weeks
详细描述
This study was terminated on 29 September 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have participated in specific Phase 3 parent study
排除标准
- •Failed screening for parent study, pregnant women, lactating mothers
结局指标
主要结局
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: Baseline up to Early Termination (Day 107)
An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is an AE resulting in any of the 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, up to early termination (Day 107) that were absent before treatment in this study or that worsened relative to pretreatment state.
Number of Participants With Anti-Drug (Tanezumab) Antibody (ADA)
时间窗: Baseline up to Early Termination (Day 107)
Human serum ADA samples were analyzed for the presence or absence of anti-tanezumab antibodies by using the semi-quantitative enzyme-linked immunosorbent assay (ELISA).
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
时间窗: Baseline up to Early Termination (Day 107)
Following parameters were analyzed for ECG abnormality: PR interval, QRS interval, QT interval, QT interval corrected using the Bazett's formula (QTcB), QT interval corrected using Fredericia's formula (QTcF), RR interval and heart rate (HR).
Number of Participants With Clinically Significant Laboratory Abnormalities
时间窗: Baseline up to Early Termination (Day 107)
Laboratory examination included blood chemistry, hematology and urinalysis. Reported results were to include abnormal laboratory findings without regard to baseline abnormality.
Number of Participants With Neurologic Examination Abnormalities
时间窗: Baseline up to Early Termination (Day 107)
Neurologic examination assessed the strength of groups of muscles of the head and neck, upper limbs and lower limbs, deep tendon reflexes and sensation (tactile, vibration, joint position sense and pin prick) of index fingers and great toes.
Number of Participants With Injection Site Reactions
时间窗: Baseline up to Early Termination (Day 107)
Injection site reactions included: erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection has been administered.
次要结局
- Time to Discontinuation Due to Lack of Efficacy(Baseline up to Week 64)
- Number of Participants With Cumulative Reduction From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score(Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64)
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64(Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64)
- Change From Baseline in WOMAC Pain Subscale Item (Pain When Walking on a Flat Surface) at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64(Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64)
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64(Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64)
- Percentage of Participants With Improvement of At Least (>=) 2 Point in Patient Global Assessment (PGA) of Osteoarthritis(Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64)
- Number of Participants Who Received Concomitant Analgesic Medication for Osteoarthritis Treatment(Baseline up to Day 107 (Early Termination))
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Physical Function Subscale Score at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64(Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64)
- Change From Baseline in Patient Global Assessment (PGA) of Osteoarthritis at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64(Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64)
- Percentage of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score(Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64)
- Percentage of Participants With Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) Response(Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64)
- Tanezumab Plasma Concentration(Pre-dose on Week 8, 24, 40; Week 56, 64)
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Average Score at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64(Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64)
- Nerve Growth Factor (NGF) Serum Concentration(Pre-dose on Week 8, 24, 40; Week 56, 64)
- Change From Baseline in WOMAC Pain Subscale Item (Pain When Going Up or Down Stairs) at Week 4, 8, 16, 24, 32, 40, 48, 56, and 64(Baseline, Week 4, 8, 16, 24, 32, 40, 48, 56, 64)
- Days Per Week of Concomitant Analgesic Medication Usage for Osteoarthritis Treatment(Baseline up to Week 64)