EUCTR2006-004547-35-DE进行中（未招募）不适用
Phase IV study to investigate neutrophil downregulation of Thy-1 by Raptiva® (Efalizumab) as a potential responder predictor in patients with moderate to severe plaque psoriasis - Responder Prediction Study
Serono GmbH0 个研究点开始时间: 2006年11月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Adult patient with moderate to severe chronic plaque psoriasis (PASI = 12) who has failed to respond to, or who has a contraindication to, or is intolerant to other systemic therapies including cyclosporine, methotrexate and Psoralen ultraviolet light A (PUVA) according to SmPC
- •2. 18 to 75 years old
- •3. Body weight max. 120 kg
- •4. Discontinuation of any systemic psoriasis treatment prior to commencement of the study treatment. An appropriate washout period is required for these agents (e.g. for cyclosporin, corticosteroids, methotrexate, retinoids, MMF, thioguanine, hydroxyurea, sirolimus, azathioprine, and 6-MP); and for any systemic immunosuppressive treatment applied for psoriasis. The specific wash out requirements must be followed for each systemic therapy and a wash out period of at least one month prior to receiving the first dose of study drug (SD 0) is required, if not indicated otherwise.
- •Application of PUVA treatment must have been discontinued one month prior to receiving the first dose of study drug (SD 0); biologic agents must not have been applied within three months prior to receiving the first dose of study drug (SD 0)
- •5. Discontinuation of all high potency topical corticosteroid treatments for psoriasis at least 14 days prior to receiving the first dose of study drug (SD 0)
- •6. Discontinuation of any investigational drug or treatment prior to commencement of the study treatment. A washout period of two months is required for these agents prior to receiving the first dose of study drug (SD 0)
- •7. Treatment regimens of ß-blockers, ACE inhibitors, antimalarial drugs, quinidine, interferon, or lithium stable for at least 28 days prior to receiving the first dose of study drug (SD 0)
- •8. No required vaccination (e.g. tetanus, booster, influenza vaccine) at least 14 days prior to receiving the first dose of study drug (SD 0).
- •9. Willingness to hold sun exposure reasonably constant and to avoid use of tanning booths or other UV light sources during the study
- •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. Guttate, erythrodermic or pustular psoriasis as sole or predominant form of psoriasis
- •2. History of severe allergic or anaphylactic reactions to humanised monoclonal antibodies
- •3. History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
- •4. History of opportunistic infections (e.g., systemic fungal infections, parasites)
- •5. History of or ongoing active tuberculosis (TB) or other serious infections
- •6. History of clinically significant thrombocytopenia, bleeding disorders or a platelet count < 50,000
- •7. Application of any biologic agent within 3 months prior to receiving the first dose of study drug (SD 0)
- •8. Application of systemic treatments (see inclusion criteria) within 1month prior to receiving the first dose of study drug (SD 0)
- •9. Application of any systemic immunosuppressive treatment applied for any condition other than psoriasis within 1 month prior to receiving the first dose of study drug (SD 0)
- •10. UV/PUVA treatment within 1month prior to receiving the first dose of study drug (SD 0)
- •11. Application of any investigational drug or treatment less than 2 months ago prior to receiving the first dose of study drug (SD 0)
- •12. Application of live or killed virus or bacteria vaccines within 14 days prior to receiving the first dose of study drug (SD 0)
- •13. Presence of malignancy within the past 5 years, including lymphoproliferative disorders. Patients with a history of fully resolved basal cell or squamous cell skin cancer may be enrolled
- •14. Diagnosis of hepatic cirrhosis, regardless of cause or severity
- •15. Hospital admission for cardiac disease, stroke, or pulmonary disease within the last year
- •16. History of drug abuse within the last 5 years
- •17. History of seropositivity for human immunodeficiency virus (HIV)
- •18. History of seropositivity for hepatitis B or C virus
- •19. WBC count <4,000/L or >14,000/L
- •20. Hepatic enzymes 3 times the upper limit of normal
- •21. Serum creatinine 2 times the upper limit of normal
研究者
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