ISRCTN45278838已完成未知
An open label, pilot, multicentre, stepdown, randomised controlled trial to examine whether etanercept 25 mg once weekly is effective in maintaining a clinical response in patients with ankylosing spondylitis who have responded to 50 mg once weekly
orfolk and Norwich University Hospital NHS Foundation Trust (UK)0 个研究点目标入组 50 人开始时间: 2011年1月21日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •At screening/baseline:
- •The participant will be placed on etanercept 50 mg once weekly providing:
- •1. Diagnosis of AS according to the modified New York criteria
- •2. Confirmation of sustained active spinal disease, demonstrated by:
- •2.1. BASDAI score of at least 4 units
- •2.2. At least 4 cm on a 0-10cm spinal pain visual analogue scale (VAS)
- •2.3. Both severity measures demonstrated on two occasions at least 12 weeks apart without any change of treatment
- •3. Conventional treatment with two or more NSAIDs taken sequentially at maximum tolerated or recommended dosage for 4 weeks have failed to control symptoms
- •4. Participant has clinically acceptable results from laboratory screening test
- •5. Male or Female, aged 18 - 80 years
- •6. Participant is willing and able to give informed consent to participate in the study
- •7. Able (in the Investigators opinion) and willing to comply with all study requirements
- •At randomisation:
- •The participant will be randomised to 50 mg or 25 mg etanercept providing:
- •1. An adequate response to treatment has been achieved, with response defined as:
- •1.1. Reduction of the BASDAI score to 50% of the pre-treatment value, or
- •1.2. Reduction in BASDAI by 2 or more units, and
- •1.3. Reduction of the spinal pain VAS by 2 cm or more
- •2. The participant finds etanercept acceptable and wishes to continue treatment
排除标准
- •At screening/baseline:
- •The participant will not enter the study if ANY of the following apply:
- •1. Previous treatment with any licensed or experimental anti TNF therapy
- •2. Chronic infection of the upper respiratory tract (e.g. sinusitis), chest (e.g. bronchiectatic lung disease), urinary tract or skin (e.g. paronychia, chronic ulcers, open wounds)
- •3. Serious infections (such as pneumonia or pyelonephritis) in the previous 3 months
- •4. Any ongoing or active infection or any major episode of infection requiring hospitalisation or treatment with intravenous (IV) antibiotics within the preceding 30 days and/or orally administered antibiotics in the preceding 15 days
- •5. Received any live (attenuated) vaccines within four weeks of screening visit
- •6. Known immunosuppressive disease or treatment with immunosuppressive drugs
- •7. Active/latent tuberculosis as identified by local screening guidelines
- •8. Stable corticosteroid use 10 mg OD taken in the 4 weeks prior to screening
- •9. History of hepatitis B or C
- •10. Significant concurrent cardiovascular disease including; uncompensated congestive heart failure, myocardial infarction within 12 months, unstable angina pectoris, uncontrolled hypertension
- •11. Cancer or a history of cancer (other than resected cutaneous basal cell carcinoma, and in situ cervical cancer) within five years of entering the screening period
- •12. Significant renal or hepatic impairment
- •13. Leukopaenia (WBC less than 3000 x 10^6/L) and/or neutropeania (WBC less than or equal to 1500 x 10^6/L)
- •14. Thrombocytopaenia (platelets less than 150 x 10^9/L)
- •15. Demyelinating disorders such as multiple sclerosis
- •16. Women who are pregnant, lactating or of childbearing potential not using contraception
- •17. Scheduled elective surgery/procedures requiring general anaesthesia during the study
- •18. Allergy to latex (the needle cover of the syringe contains latex)
- •19. Presence of any other significant and uncontrolled medical condition, which in the investigator's opinion precludes the use of etanercept
- •20. Unable to give informed consent
- •21. Unable/unwilling to comply with study procedures
- •22. Not available for followup assessments
- •23. Received treatment with an investigational drug within 12 weeks prior to study screening
- •24. History of back injury or trauma which confounds the clinical scenario
- •At randomisation:
- •The participant will not be randomised if ANY of the following apply:
- •1. An adequate response to etanercept 50 mg per week has not been achieved by the end of the 6 month lead in period
- •2. The participant wishes to discontinue treatment with etanercept
- •3. On the basis of adverse reactions, the treating physician considers the participant should withdraw from treatment with etanercept
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