NCT00096980已完成4 期
An Open Label, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneously Administered Efalizumab Used in Combination With Topical Psoriasis Therapies for Prolonged Maintenance Treatment
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
研究概览
简要总结
This study is an open label, randomized, multicenter study designed to compare the efficacy of 12 weeks of subcutaneously administered efalizumab (monotherapy) with that of combination therapy (Efalizumab and a topical corticosteroid ointment) in subjects with moderate to severe plaque psoriasis who are candidates for systemic therapy. The study will also evaluate the safety and tolerability of 30 months of continuous efalizumab treatment in those subjects who derive benefit from the initial 12 weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Diagnosis of plaque psoriasis for >=6 months
- •A minimum Psoriasis Area and Severity Index (PASI) score of 12.0 at screening
- •Plaque psoriasis covering >=10% of total Body Surface Area (BSA)
- •In the opinion of the investigator, candidate for systemic therapy for psoriasis who has not been previously treated (naive to systemic treatment) or who has received prior systemic therapy for psoriasis (e.g., PUVA, cyclosporine, corticosteroids, methotrexate, oral retinoids, mycophenolate mofetil [MMF], thioguanine, hydroxyurea, sirolimus, azathioprine, 6 MP, etanercept)
- •18 to 70 years old
排除标准
- •Guttate, erythrodermic, or pustular psoriasis as sole or predominant form of psoriasis
- •Clinically significant psoriasis flare during the 3 months prior to enrollment
- •Pregnancy or lactation
- •History of or ongoing uncontrolled bacterial, viral, fungal, or atypical mycobacterial infection
- •History of opportunistic infections (e.g., systemic fungal infections, parasites)
- •Seropositivity for hepatitis B or C virus
- •Seropositivity for human immunodeficiency virus (HIV)
- •History of active tuberculosis (TB) or currently undergoing treatment for TB
- •Presence or history of malignancy within the past 5 years, including lymphoproliferative disorders
- •Diagnosis of hepatic cirrhosis, regardless of cause or severity
- •Hospital admission for cardiovascular or pulmonary disease within the last year
- •History of substance abuse within the last 5 years
- •History of severe allergic or anaphylactic reactions to monoclonal antibodies or fusion proteins, which contain an immunoglobulin (Ig) Fc region (e.g., etanercept, LFA3TIP)
- •History of severe allergic reactions to or intolerance of topical corticosteroid therapies
- •Previous treatment with efalizumab
- •History of treatment with lymphocyte-depleting monoclonal antibodies or immunoadhesion molecules (e.g., anti-CD4, CTLA4-Ig, LFA3TIP)
- •WBC count <4000/uL or >14,000/uL
- •Hepatic enzymes >=3 times the upper limit of normal
- •Creatinine >=2 times the upper limit of normal
- •Any medical condition that, in the judgment of the investigator, would jeopardize the subject's safety following exposure to study drug
- •Any medical or other condition that, in the judgment of the investigator, would significantly interfere with the subject's ability to comply with the provisions of this protocol
- •Topical therapy for psoriasis
- •Systemic therapy for psoriasis
- •Systemic immunosuppressive drugs
- •Tanning beds, booths, or home UV light sources
- •Live virus or bacteria vaccine
- •Other vaccines or allergy desensitization injections
- •Other experimental drugs or treatments
- •Nonsteroidal anti inflammatory drugs
研究者
相似试验
已完成
3 期
Study Comparing Efficacy and Safety of Mycophenolate Mofetil (Cellcept) With Delayed Introduction of Sirolimus and Discontinuation of Cyclosporine, With Those of Mycophenolate Mofetil and Long Term Continuation of Cyclosporine in Renal Transplant RecipientsRenal TransplantationNCT02686619Hoffmann-La Roche237
已完成
3 期
Posaconazole Treatment of Invasive Fungal Infection (IFI) (P05551)Fungal InfectionNCT00811642Merck Sharp & Dohme LLC63
尚未招募
2 期
A Study to Evaluate the Efficacy and Safety of Oral Navelbine in Female Patients With HER2-Negative Metastatic Breast CancerHuman Epidermal Growth Factor 2 Negative Carcinoma of BreastNCT03854617Chinese Academy of Medical Sciences172
终止
3 期
Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir AloneHepatitis BNCT00376259Novartis43
已完成
不适用
Study to Evaluate the Effectiveness, Safety and Long Term Safety of Saypha® FILLER Lidocaine for Lip AugmentationAbnormal LipNCT04917588Croma-Pharma GmbH114