A PHASE 3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY OF THE LONG-TERM ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB ALONE OR IN COMBINATION WITH NON-STEROIDAL ANTIINFLAMMATORY DRUGS (NSAIDS) VERSUS NSAIDS ALONE IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP

Pfizer Inc., 235 East 42nd Street, New York, NY 100170 个研究点目标入组 2,500 人开始时间: 2008年12月29日最近更新: 2012年3月19日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Pfizer Inc., 235 East 42nd Street, New York, NY 10017
入组人数: 2,500

研究概览入排标准研究者记录与标识符相似试验

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

•Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
•1. Patients must consent in writing to participate in the study by signing and dating an informed consent document indicating that the patient has been informed of all pertinent aspects of the study prior to completing any of the Screening procedures;
•2. Male or female of any race, =18 years of age;
•3. At Screening, patients must have a diagnosis of OA of the index joint (knee or hip) based on American College of Rheumatology criteria with radiographic (X-ray) confirmation (a Kellgren-Lawrence x-ray grade of =2).
•4. Patients must be experiencing some benefit from their current stable dose regimen of oral NSAID therapy of either naproxen 1000 mg/day (either 500 mg BID or sustained release 1000 mg QD) or celecoxib 200 mg/day (either 100 mg BID or 200 mg QD), be tolerating their NSAID regimen, 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 and must have had some improvement in OA index joint pain, but still requiring additional pain relief at Screening. Patients must remain on their pre-Screen oral NSAID of celecoxib or naproxen for at least the final 2 weeks of the Screening Period directly prior to the Baseline (Randomization / Day 1) Visit for an average of at least 5 of 7 days per week (ie, minimum 70% compliance);
•5. To be eligible for this study, the patient must meet each of the following 3 criteria:
•WOMAC Pain subscale NRS =4 in the index knee or index hip at Screening and Baseline;
•WOMAC Physical Function subscale NRS =4 in the index knee or index hip at Baseline;
•Patient Global Assessment of Osteoarthritis must be fair,” poor,” or very poor” at Baseline;
•6. Patients must be willing to discontinue all non-study pain medications for OA except rescue medication and not use prohibited pain medications throughout the duration of the study except as permitted per Protocol.
•7. Female patients must meet one of the following criteria:
•a. Female patients of non-childbearing potential: post-menopausal, defined as women who are =45 years old with amenorrhea for 24 consecutive months (regardless of FSH levels); amenorrhea for at least 1 year AND have a serum Follicle-Stimulating Hormone (FSH) level greater than 30 IU/L at Screening; or surgically sterile, defined as having had a hysterectomy and/or bilateral oophorectomy;
•b. Female patients of child-bearing potential: must not be pregnant or lactating and must be abstinent or use adequate contraception (2 forms of birth control, one of which must be a barrier method);
•Women of childbearing potential must have a negative serum pregnancy test at Screening (within 30 days prior to Baseline) and a negative urine pregnancy test at Baseline prior to initial dosing.
•Male patients must agree that they and their female spouses / partners will use adequate contraception (2 forms of birth control, one of which must be barrier method) or be of non-childbearing potential.
•Females of child-bearing potential and males must be willing to use approved methods of contraception from commencement of Screening procedures until 16 weeks (112 days) after last dose of IV study medication. In the event of indeterminate or anomalous results on pregnancy/FSH testing or issues surrounding contraceptive requirements, Study Management should be contacted and will make the final decision as to the adequacy/ne

排除标准

•1. Pregnant women, lactating mothers, women suspected of being pregnant, and women who wish to be pregnant during the course of clinical study;
•2. Body Mass Index (BMI) of >39 kg/m2;
•3. History of other disease that may involve the index joint (knee or hip);
•4. History of significant trauma or surgery to the index knee or hip within the previous year;
•5. Planned surgical procedure during the duration of the study;
•6. Largely or wholly incapacitated;
•7. Fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with OA;
•8. History of cancer within the last 5 years except for cutaneous basal cell or squamous cell cancer resolved by excision.
•9. Signs and symptoms of clinically significant cardiac disease.
•Patients with a history of heart block now controlled by a functioning cardiac pacemaker and/or transient episodes of asymptomatic tachy- or bradyarrhythmias are eligible.
•10. Diagnosis of a transient ischemic attack in the 6 months prior to Screening, diagnosis of stroke with residual deficits that would preclude completion of required study activities.
•11. History, diagnosis, signs or symptoms of clinically significant neurological disease.
•12. History, diagnosis, signs or symptoms of any clinically significant psychiatric disorder.
•13. Hospital admission for depression or suicide attempt within 5 years prior to Screening or presence at Screening of active severe major depression (determined from medical history or a score =15 on Patient Health Questionnaire [PHQ-9];
•14. History of known alcohol, analgesic or drug abuse within 2 years of Screening;
•15. Previous exposure to exogenous NGF or to an anti-NGF antibody;
•16. History of allergic or anaphylactic reaction to a therapeutic or diagnostic monoclonal antibody or IgG-fusion protein;
•17. History of intolerance or hypersensitivity to acetaminophen (paracetamol) or any of its excipients or existence of a medical condition or use of concomitant medication for which the use of acetaminophen (paracetamol) is contraindicated;
•18. Resting, sitting systolic blood pressure >160 mm Hg or diastolic blood pressure >100 mm Hg at Screening;
•19. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =3.0 times the upper limit of normal (ULN), or creatinine exceeding 1.7 mg/dL (150 µmol/L) in men or 1.5 mg/dL (133 µmol/L) in women, or hemoglobin A1c =10% at Screening. Repeat confirmatory tests may be performed;
•20. Presence of drugs of abuse (including prescription medications without a valid prescription), other illegal drugs or marijuana in the urine toxicology screen obtained at Screening;
•21. Positive Hepatitis B, Hepatitis C, or Human Immunodeficiency Virus (HIV) tests at Screening indicative of current or past infection;
•22. Oral or intramuscular corticosteroids within 30 days prior to Baseline;
•23. Intra-articular corticosteroids in the index knee or hip within 12 weeks or to any other joint within 30 days, prior to Baseline;
•24. Intra-articular hyaluronic acid to the index knee or hip within 30 days prior to Baseline;
•25. Patients on warfarin or other coumadin anticoagulant therapy within 30 days prior to Screening. Patients with a significant likelihood of requiring one of these medications;
•26. Patients on lithium therapy within 30 days prior to Screening. Patients with a significant likelihood of requiring this medicatio

研究者

发起方

Pfizer Inc., 235 East 42nd Street, New York, NY 10017

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