NCT01132235Unknown4 期
An Open-label Study to Evaluate the Efficacy of Re-treatment for Patients With a History of Etanercept Use
Florida Academic Dermatology Centers2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2010年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The proportion of patients achieving a Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of re-treatment with etanercept 50mg subcutaneous injections twice weekly for 12 weeks in subjects who have previously been treated etanercept and efficacy diminished.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with psoriasis who have previously been treated with etanercept for a minimum of 6 months and discontinued treatment due to loss of efficacy. Every attempt will be made to obtain loss of efficacy history from the subject's medical chart;when etanercept was commenced and terminated and description of patient's psoriasis on termination and details of new treatment commenced. Subjects must have failed their latest psoriasis treatment after a period of three months. This will be measured as a PGA of ≥
- •There is no specific requirement as to when prior treatment with etanercept occurred and no requirement as to what type of treatment(s) used between initial and subsequent treatments.
- •Are ≥ 18 years of age
- •BSA minimum of 5%
- •Tuberculosis inclusion criteria
- •Have no history of latent or active TB prior to screening.
- •Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
- •Have had no recent close contact with a person with active TB.
- •Within 1 month prior to the first administration of study have a negative tuberculin skin test.
- •The ability to give written informed consent and comply with study procedures.
排除标准
- •Current enrollment in any other investigational device or investigational drug trial(s), or receipt of any other investigational agent(s) within 28 days before baseline visit.
- •Known hypersensitivity to Enbrel® (etanercept) or any of its components or known to have antibodies to etanercept.
- •Latex sensitivity [NB: only applicable if they are using prefilled syringe or prefilled SureClick™ autoinjector presentations]
- •Prior or concurrent use of cyclophosphamide therapy
- •Concurrent sulfasalazine therapy.
- •A positive HBV test or known history of any other immuno-suppressing disease.
- •Any mycobacterial disease or high risk factors for tuberculosis (TB), such as family member with TB, positive purified protein derivative (PPD) or taking anti-tuberculosis medication.
- •Active or chronic infection within 4 weeks before screening visit, or between the screening and baseline visits.
- •History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection and Hepatitis C, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB, or other opportunistic infections
- •If etanercept was previously discontinued due to a serious adverse event
- •Severe comorbidities (diabetes mellitus requiring insulin; CHF of any severity; or myocardial infarction, cerebrovascular accident or transient ischemic attack within 6 months of screening visit; unstable angina pectoris; uncontrolled hypertension (sitting systolic BP <80 mm Hg or > 160 or diastolic BP > 100 mm Hg); oxygen-dependent severe pulmonary disease; history of cancer within 5 years [other than resected cutaneous basal or squamous cell carcinoma of the skin or in situ cervical cancer])
- •Systemic lupus erythematosus, history of multiple sclerosis, transverse myelitis, optic neuritis or seizure disorder.
- •Use of a live vaccine 90 days prior to screening visit, or concurrent use of a live vaccine.
- •Any condition or circumstances judged by the patient's physician [or the investigator or medically qualified study staff] to render this clinical trial detrimental or otherwise unsuitable for the patient's participation.
- •Female subjects who are pregnant, nursing or planning pregnancy (both men and women) and not using acceptable methods of birth control during the trial (hormonal, barriers, abstinence).
- •Women who are breast feeding
- •History of non-compliance with other therapies.
- •History of alcohol abuse within the last 12 months
- •Concurrent use of anakinra
- •Subjects who cannot discontinue any of the drugs below for 2 weeks prior to the baseline visit or during the study;
- •A two week wash out period is appropriate as it would be unethical to expect subjects whose disease if flaring to remain untreated for a longer period of time. The first dose of etanercept will be administered two weeks after the last biologic dose.
- •Immunosuppressants, antimalarials, or sulfasalazine.
- •Other Ani-TNFs
- •Cyclosporine
- •Efalizumab
- •Azathioprine
- •Hydroxyurea
- •Live vaccines
- •Tacrolimus
- •Oral retinoids (isotretinoin,acitretin,bexarotene)
- •Ultra violet light therapies
结局指标
主要结局
The proportion of patients achieving a Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12.
时间窗: 12 weeks
Physician's Global Assessment (PGA) score of minimal (1) or clear (0) at week 12 will measure efficacy of retreatment with etanercept
次要结局
未报告次要终点
研究者
研究点 (2)
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