EUCTR2008-002354-38-GB进行中（未招募）不适用
A Phase IV, prospective, open label multicentre study of Raptiva 1mg/kg/week by subcutaneous injection in adults with moderate to severe chronic plaque psoriasis who have failed previous biologic therapy with etanercept. - Open label investigation of Raptiva efficacy in subjects who have failed on Enbrel.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 110
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
- •i.At least 18 years of age.
- •ii.Have plaque psoriasis with a PASI score of at least 10 at time of initiation of etanercept treatment
- •iii.Have failed to respond to, or are in tolerant to, etanercept therapy as determined by their treating physician
- •iv.Agree to participate in the study, and disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study
- •v.Have given written consent with the understanding that consent may be withdrawn at any time without prejudice to future medical care
- •vi.For women of childbearing potential, use of an acceptable method of contraception to prevent pregnancy and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study
- •vii.Discontinuation of any investigational drug or treatment 3 months prior to study start or as per washout requirements from previous 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 Any contra-indication to Raptiva, according to the Investigator Brochure, or as follows:
- •Hypersensitivity to Raptiva or to any of the excipiants
- •Subjects with history of malignancies, including lymphoproliferative disease.
- •Subjects with active or latent tuberculosis within one year prior to screening (to be determined by assessement according to national and / or local recommendations), or other severe infections.
- •Subjects with specific forms of psoriasis like guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis
- •Subjects with immunodeficiencies
- •2. Simultaneous participation in another clinical trial
- •3. Subjects experiencing a psoriasis exacerbation during screening period
- •4. Subjects with significant psoriatic arthritis (DAS28>5.1)
- •5. Subjects who have previously been on Raptiva treatment who withdrew due to lack of efficacy or an adverse event. If withdrawal was due to another non-drug reason (eg. Vaccination) then the subject can be included in this study
- •6. History of hepatitis B, C or huma immunodeficiency virus (HIV)
- •7. History of thrombocytopenia, haemolytic anaemia or clinically significant anaemia
- •8. Hepatic enzyme levels >=3 times the upper limit of normal or serum creatinine level >= 2 times the upper limit of the normal
- •9. Pregnant or breast feeding
- •10. Any medical condition (prior or existing) that, in the judgement of the investigator or sponsor, could jepardize the subject’s safety following exposure to study drug
- •11. Subjects with body weight of >200kg
- •12. Vaccination with a live or live-attenuated vaccine within 14 days prior to the first dose of investigational medicinal drug
- •Note: Raptiva should be used with caution in subjects with renal or hepatic impairment
研究者
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