EUCTR2006-004971-37-GB进行中（未招募）不适用
Adalimumab for psoriasis patients who are non-responders to etanercept: An open-label study - adalimumab for psoriasis patients who are non-responders to etanercept
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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.Plaque-type psoriasis
- •2.Non-responders to etanercept (ref: 2.2 Trial design)
- •3.Male and female subjects >18 years of age
- •4.Subjects must not have live vaccination during the study period.
- •5.If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion:
- •a)Barrier methods (condoms or intrauterine device)
- •b)Contraceptives (oral, parenteral, transdermal or implantable) starting from three months prior to study drug administration
- •c)Vasectomized partner
- •d)Total abstinence from sexual intercourse
- •e)Must have a negative serum pregnancy test at Screening and Baseline.
- •6.Normal chest x-ray (posterior–anterior and lateral) within 3 months prior to screening with no evidence of malignancy, infection or fibrosis.
- •7.Subject must meet the tuberculosis (TB) eligibility assessment and screening requirement according to current British Association of Dermatologists guidelines.
- •8.Subject is judged to be in good general health, as determined by investigator, based upon the results of a medical history, laboratory evaluations and the physical examination performed at screening and/or baseline.
- •9.Ability and willingness to self-administer subcutaneous injections or have available qualified person(s) to administer subcutaneous injections
- •10.Ability and willingness to give written informed consent or assent and to comply with the requirements of the protocol.
- •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. Subject has erythrodermic psoriasis, generalized or localized pustular psoriasis, medication-induced or medication-exacerbated psoriasis, or new onset guttate psoriasis.
- •2. Subject has a poorly controlled medical condition, such as uncontrolled diabetes with documented history of recurrent infections, unstable ischaemic heart disease, congestive heart failure, cardiomyopathy, significant renal or hepatic disease, depression of such severity that the subject is a suicide risk or any other condition, which, in the opinion of the investigator, would put the subject at risk by participation in the study
- •3. History of clinically significant drug or alcohol abuse within the last year
- •4. History of iv drug abuse
- •5. Pregnant or breast-feeding female
- •6. History of lupus-like illness, neurologic symptoms suggestive of central nervous system (CNS) demyelinating diseases or blood dyscrasias
- •7. Any other active skin disease or condition (e.g. bacterial, fungal or viral infection) that may interfere with assessment of psoriasis8.Subject receives or requires:
- •a.UVB phototherapy, excessive sun exposure or the use of tanning booths for < 14 days prior to Baseline visit and during the study
- •b.PUVA phototherapy < 2 weeks prior to baseline visit and throughout the study
- •c.Systemic non-biologic therapies for psoriasis < 4 weeks prior to baseline visit and throughout the study.
- •d.Investigational chemical agents must be discontinued at least 12 weeks or 5 half-lives prior to the baseline visit (whichever is longer)
- •e.Oral or injectable corticosteroids during the study. Inhaled corticosteroids for stable medical conditions are allowed.
- •9. History of any malignancy within the past 5 years, except successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in-situ of the cervix.
- •10. History of active infection with Listeria or TB
- •11. Any ongoing chronic or active infection or any episode of infection requiring hospitalization, treatment with iv antibiotics or antivirals within 30 days or oral antibiotics, antifungals or antivirals within 14 days prior to Screening
- •12. Chronic hepatitis B requiring the current use of antiviral treatment, including antiretrovirals
- •13. Chronic hepatitis C
- •14. Known positive human immunodeficiency virus (HIV) status
- •15. History of congenital immunodeficiencies
- •16. Immune deficiency or immunocompromised
- •17. Inability to comply with the study procedures or requirements
- •18. Subject has a history of an allergic reaction or significant sensitivity to constituents of study drug
研究者
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