A Multicentre, Double-Blind, Placebo-Controlled, Randomised Study of Etanercept in the Treatment of Adult Patients with Active, Severe and Advanced Axial Ankylosing Spondylitis

Wyeth Pharmaceuticals France0 个研究点目标入组 80 人2006年11月20日

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注册库

who.int

开始日期

2006年11月20日

结束日期

待定

最后更新

14年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

Wyeth Pharmaceuticals France

•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.

•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 NSAID 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.