EUCTR2012-003721-22-SK进行中（未招募）1 期
A PHASE 3 RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, MULTICENTER STUDY OF THE LONG-TERM SAFETY AND EFFICACY OF SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer Inc
- 入组人数
- 3,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
- •- Male or female of any race,>=18 years of age.
- •- A diagnosis of osteoarthritis of the index hip or knee based on American College of Rheumatology criteria with X-ray confirmation (a Kellgren-Lawrence X-ray Grade of >=2 as diagnosed by the Central Reader).
- •-Subjects must meet the following criteria pertaining to their osteoarthritis treatment regimen:
- •Documented history indicating that acetaminophen therapy has not provided sufficient pain relief;
- •Currently receiving a stable dose regimen of oral NSAID therapy consisting of one of the NSAIDs presented in the following table, be tolerating this NSAID and be taking this medication regularly (defined as an average of at least 5 days per week) during the 30 day period prior to the Screening visit):
- •Table 7. Qualifying Pre-study NSAID Treatment Regimens
- •NSAID Qualifying Dose Range
- •Naproxen 440 mg/day* to 1000 mg/day
- •Celecoxib 200 mg/day (either 100 mg BID or 200 mg QD)
- •Diclofenac 100 mg/day to 150 mg/day
- •Aceclofenac 200 mg/day
- •Loxoprofen 120 mg/day to 180 mg/day
- •Ibuprfen 1200 mg/day to 3200 mg/day
- •Meloxicam 5 mg/day to 15 mg/day
- •Nabumetone 1000 m/day to 2000 mg/day
- •Sulindac 200 mg/day to 400 mg/day
- •Ketoprofen 200 mg/day
- •Maintain compliance with a stabilized dose regimen of either naproxen 500 mg BID, celecoxib 100 mg BID or diclofenac ER 75 mg BID (provided at Screening) with a minimum compliance of 70% (ie 5 of 7 days per week) for the final 2 or 3 weeks of the Screening period directly prior to the Baseline (Day 1) visit.
- •AND at least 1 of the following criteria:
- •Documented history indicating that tramadol treatment has not provided adequate pain relief or subject is unable to take tramadol due to contraindication or inability to tolerate;
- •Documented history indicating that opioid treatment has not provided adequate pain relief or subject is unwilling to take opioids, or unable to take opioids due to contraindication or inability to tolerate.
- •- WOMAC Pain subscale NRS >=5 in the index knee or index hip at Screening.
- •- Female subjects of childbearing potential and at risk for pregnancy must agree to use 2 highly effective methods of contraception throughout the study and for 112 days (16 weeks) after the last dose of assigned subcutaneous investigational product.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1950
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1050
排除标准
- •- History or radiographic evidence of other diseases that could confound efficacy assessments (e.g., rheumatoid arthritis).
- •- History or radiographic evidence of orthopedic conditions that may increase the risk of, or confound assessment of joint safety conditions during the study.
- •- Planned surgical procedure during the duration of the study.
- •- A past history of carpal tunnel syndrome (CTS) with signs or symptoms of CTS in the one year prior to Screening.
- •- History of intolerance or hypersensitivity to the relevant oral NSAID (naproxen, celecoxib or diclofenac) the subject could be randomized to receive or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of this NSAID is contraindicated (refer to product labeling).
- •- Signs and symptoms of clinically significant cardiac disease within 6 months of the study (e.g., unstable angina, myocardial infarction, resting bradycardia, poorly controlled or untreated hypertension) as defined in the protocol or subjects with any other cardiovascular illness that in the opinion of the Investigator would render a subject unsuitable to participate in the study or Subjects with a history of heart block requiring ongoing treatment of that is associated with symptoms.
- •- History, diagnosis, or signs and symptoms of clinically significant neurological disease (e.g., transient ischemic attack, stroke, peripheral or autonomic neuropathy) as specified in the protocol
- •- Subjects with evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol.
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