EUCTR2010-020913-10-GB进行中（未招募）1 期
An open label, pilot, multi-centre, step-down, randomised controlled trial to examine whether Etanercept 25mg once weekly is effective in maintaining a clinical response in patients with Ankylosing Spondylitis who have responded to 50mg once weekly - ANSWERS
orfolk & Norwich University Hospitals NHS Foundation Trust0 个研究点目标入组 50 人开始时间: 2010年7月23日最近更新:
适应症
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
- 50
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
入选标准
- •At screening / baseline
- •The participant will be placed on Etanercept 50mg once weekly providing:
- •a) Diagnosis of AS according to the modified New York criteria (Study Protocol, Appendix 1).
- •b) Confirmation of sustained active spinal disease, demonstrated by:
- •i. BASDAI score of at least 4 units (Study Protocol, Section 5.6)
- •ii. At least 4 cm on a 0-10cm spinal pain visual analogue scale (VAS)
- •iii. Both severity measures demonstrated on two occasions at least 12 weeks apart without any change of treatment
- •c) Conventional treatment with two or more NSAIDs taken sequentially at maximum tolerated or recommended dosage for 4 weeks have failed to control symptoms.
- •d) Participant has clinically acceptable results from laboratory screening test.
- •e) Male or Female, aged 18 – 80 years
- •f) Participant is willing and able to give informed consent to participate in the study.
- •g) Able (in the Investigators opinion) and willing to comply with all study requirements.
- •At randomisation
- •The participant will be randomised to 50mg or 25mg Etanercept providing:
- •a) An adequate response to treatment has been achieved, with response defined as:
- •i. reduction of the BASDAI score to 50% of the pre-treatment value OR
- •ii. reduction in BASDAI by 2 or more units AND
- •iii. reduction of the spinal pain VAS by 2 cm or more.
- •b) The participant finds Etanercept acceptable and wishes to continue treatment
- •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
- •At screening / baseline: the participant will not enter the study if ANY of the following apply:
- •a) Previous treatment with any licensed or experimental anti TNF therapy.
- •b) 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).
- •c) Serious infections (such as pneumonia or pyelonephritis) in the previous 3 months.
- •d) 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.
- •e) Received any live (attenuated) vaccines within four weeks of screening visit.
- •f) Known immunosuppressive disease or treatment with immunosuppressive drugs.
- •g) Active / latent tuberculosis as identified by local screening guidelines.
- •h) Stable corticosteroid use =10mgs OD taken in the 4 weeks prior to screening.
- •i) History of hepatitis B or C.
- •j) Significant concurrent cardio-vascular disease including; uncompensated congestive heart failure, myocardial infarction within 12 months, unstable angina pectoris, uncontrolled hypertension.
- •k) 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.
- •l) Significant renal or hepatic impairment.
- •m) Leukopaenia (wbc <3000 x 10^6/L) and/or neutropeania (wbc =1500 x 10^6/L).
- •n) Thrombocytopaenia (platelets less than 150 x 10^9/L).
- •o) Demyelinating disorders such as multiple sclerosis.
- •p) Women who are pregnant, lactating or of childbearing potential not using contraception.
- •q) Scheduled elective surgery/procedures requiring general anaesthesia during the study.
- •r) Allergy to latex (the needle cover of the syringe contains latex).
- •s) Presence of any other significant and uncontrolled medical condition, which in the investigator's opinion precludes the use of Etanercept
- •t) Unable to give informed consent
- •u) Unable/unwilling to comply with study procedures.
- •v) Not available for follow-up assessments
- •w) Received treatment with an investigational drug within 12 weeks prior to study screening.
- •x) 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:
- •a) An adequate response to Etanercept 50mg per week has not been achieved by the end of the 6 month lead in period.
- •b) The participant wishes to discontinue treatment with Etanercept.
- •c) On the basis of adverse reactions, the treating physician considers the participant should withdraw from treatment with Etanercept.
研究者
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