EUCTR2005-001549-41-IT进行中（未招募）不适用
A Randomised, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects with Ankylosing Spondylitis - ASCEND
WYETH LEDERLE0 个研究点目标入组 525 人开始时间: 2008年10月9日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 525
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 AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
- •2.Active AS, defined on a scale of 0 to 100 by:
- •·Average duration and intensity of morning stiffness visual analogue scale (VAS) of nlt 30;
- •·At least 2 of the following:
- •-Patient global assessment VAS nlt 30;
- •-Average nocturnal and total pain VAS nlt 30;
- •-Bath Ankylosing Spondylitis Functional Index (BASFI) VASnlt 30.
- •3.Presence of peripheral arthritis, defined as nlt 1 tender/painful and swollen peripheral joint or nlt 1 tender/painful hip or shoulder joint.
- •4.Treatment failure to at least one NSAID of at least three months duration at the maximal recommended or tolerated anti-inflammatory dose, unless NSAIDs are contraindicated.
- •5.18 years of age or older at time of consent.
- •6.Negative serum pregnancy test taken at screening in all women except those who were surgically sterile or at least 1 year postmenopausal.Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception.
- •7.Agreement by male subjects who are not surgically sterile and female subjects who are not surgically sterile or postmenopausal to use reliable methods of birth control for the duration of the study.
- •8.Ability to self-inject drug or have a designee who can do so.
- •9.Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
- •10.Ability to store injectable test article at 2o C to 8o 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.Complete ankylosis (fusion) of spine.
- •2.Previous treatment with etanercept, antibody to tumour necrosis factor a (TNFa), or other TNFa inhibitors or other biologic agents.
- •3.Treatment with SSZ within 6 months of screening.
- •4.History of treatment with SSZ associated with significant toxicity or significant lack of response.
- •5.Contraindication to SSZ including:
- •·Hypersensitivity to SSZ, its metabolites, sulfonamides, or salicylates
- •·History or presence of intestinal or urinary obstruction
- •·History or presence of porphyria
- •·Current treatment with digoxin
- •6.Failure to respond to treatment to more than one DMARD.
- •7.Use of DMARDs other than methotrexate or hydroxychloroquine within 4 weeks of baseline. Subjects on methotrexate or hydroxychloroquine must have been on a stable dose for at least 4 weeks prior to randomisation.
- •8.Receipt of more than one DMARD concurrently at screening.
- •9.Previous use of intravenous bisphosphonate.
- •10.Receipt of more than one NSAID concurrently at baseline.
- •11.Dose of NSAID changed within 2 weeks of baseline.
- •12.Dose of prednisone >10 mg/day (or equivalent) or changed within 2 weeks of baseline.
- •13.Receipt of intra-articular, intravenous, intramuscular, or subcutaneous corticosteroid within 4 weeks of screening.
- •14.Abnormality in haematology or chemistry profiles: haemoglobin £ 85 g/L; haematocrit nmt 27%; platelet count nmt 125 x 109 /L; white blood cell count nmt 3.5 x 109 /L; serum creatinine nlt 175 mmol/L; aspartate aminotransferase (AST [SGOT]) and alanine aminotransferase (ALT [SGPT]) nlt 2 times the laboratory?s upper limit of normal.
- •15.Significant concurrent medical events including:
- •·Uncontrolled hypertension (defined as screening systolic blood pressure > 160 mm Hg or screening diastolic blood pressure > 100 mm Hg)
- •·Myocardial infarction within 12 months of the screening visit
- •·Unstable angina pectoris
- •·Class III or IV congestive heart failure as defined by the New York Heart Association classification (16) or uncompensated congestive heart failure
- •·Severe pulmonary disease requiring hospitalisation or supplemental oxygen
- •·Diagnosis of multiple sclerosis or other central demyelinating diseases
- •·Presence or history of confirmed blood dyscrasias
- •·Uncontrolled diabetes mellitus
- •·Rheumatoid arthritis, systemic lupus erythematosus, scleroderma, or polymyositis
- •·Cancer or history of cancer (other than resected cutaneous basal cell or squamous cell carcinoma)
- •·Serious infection (infection associated with hospitalisation and/or intravenous antibiotics) within 1 month of test article administration or active infection at screening
- •·Open cutaneous ulcers
- •·Known human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) positive
- •·Tuberculosis (TB) infection
- •·Any condition that, in the investigator?s judgment, might cause this study to be detrimental to the subject
- •16. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline
- •17. Known contraindication or hypersensitivity to etanercept or its excipients.
- •18. Pregnant or breast-feeding women.
- •19. Reasonable expectation that the subject will not be able to satisfactorily complete the study
- •20. History of or current psychiatric illness that would interfere with the subject?s ability to comply with protocol requirements or give informed consent.
- •21. History of alcohol or drug abuse that would interfere with the subject?s ability to comply with protocol requirements.
- •22. Receipt of any investigational drug
研究者
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