EUCTR2006-002748-27-FR进行中（未招募）1 期
A Multicentre, Double-Blind, Placebo-Controlled, Randomized Study of Etanercept in the Treatment of Adults Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis
Wyeth Pharmaceuticals France0 个研究点目标入组 80 人开始时间: 2006年12月19日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
- •1. Diagnosis of Ankylosing Spondylitis (AS), as defined by the Modified New York criteria.
- •2. Axial, defined by a score = 30 for the overall level of AS neck, back or hip pain (on a 100 mm VAS) (question 2 of the BASDAI).
- •3. Refractory to standard anti-rheumatic treatment (at least 2 NSAIDs at maximum tolerated
- •dose with duration > 3 months and according to the opinion of the investigator).
- •4. Active, defined by BASDAI = 40 despite optimal NSAID treatment.
- •5. Advanced and severe, defined by the presence of 1 of the 3 following criteria :
- •- 2 intervertebral adjacent bridges and/or fusion of the lumbar spine,
- •- 3 intervertebral adjacent bridges and/or fusion of the dorsal spine,
- •- 2 intervertebral adjacent bridges and/or fusion of the cervical spine.
- •6. Between 18 and 70 years of age.
- •7. Negative serum pregnancy test taken at screening in all women except those surgically sterile or at least 1 year post-menopausal. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception (which includes oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception). A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who use contraceptives or whose sexual partners are either sterile or use contraceptives.
- •8. Agreement by male subjects who are not surgically sterile and female subjects who are not surgically sterile or post-menopausal to use of a reliable method of birth control for the duration of the study.
- •9. Ability to reconstitute and self-inject drug or have a designee who can do so.
- •10. Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific screening procedures are performed.
- •11. Ability to store injectable test article at 2°C-8°C.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous receipt of etanercept or other TNFa inhibitors.
- •2. Use of disease modifying drugs other than hydroxychloroquine, sulphasalazine and methotrexate within 4 weeks of baseline. Patients treated with hydroxychloroquine, sulphasalazine and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.
- •3. Receipt of multiple NSAIDs at baseline.
- •4. Dose of NSAIDs changed within 2 weeks of baseline evaluation
- •5. Dose of prednisone > 10mg/day (or equivalent) or changed within 2 weeks of baseline evaluation.
- •6. Abnormality in chemistry or haematologic profiles : white blood cell count = 3.5 x 109/L; haemoglobin = 85 g/L or 5.3 mmol/L; haematocrit = 27%; platelet count = 125 x 109/L; serum creatinine = 175 µmol/L; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2 times the laboratory’s upper limit of normal.
- •7. Significant concurrent medical events :
- •Uncompensated congestive heart failure.
- •Diagnosis of multiple sclerosis or other central demyelinating diseases.
- •Presence or history of confirmed blood dyscrasias.
- •Cancer or history of cancer (other than resected cutaneous basal cell or squamous cell carcinoma).
- •Serious infection (infection association with hospitalization and/or intravenous antibiotics) within 1 month of test article administration or active infection at baseline.
- •Any condition that, in the physician’s judgment, might cause this study to be detrimental to the subject.
- •History of HIV+ or TB+ test (follow the local country guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF alfa therapy).
- •8. Known contraindication or hypersensitivity to etanercept or its excipients.
- •9. Pregnant or breast-feeding women.
- •10. History of poor compliance.
- •11. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
- •12. History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements or give informed consent.
- •13. Receipt of any investigational drug or biological agent within 3 months of screening visit.
- •14. Employment by the investigator or reporting directly or indirectly to the investigator.
研究者
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