NCT00051662已完成1 期
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Safety, Efficacy and Pharmacokinetics of Efalizumab in Subjects With Psoriatic Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
研究概览
简要总结
The purpose of this study is to determine whether a humanized monoclonal antibody (efalizumab) is safe and effective in the treatment of psoriatic arthritis (PsA)
详细描述
A phase II, randomized, double-blind, placebo-controlled study to:
- Demonstrate the clinical efficacy of efalizumab in the treatment of subjects with psoriatic arthritis (PsA).
- Evaluate the safety, tolerability and pharmacokinetics of efalizumab in the treatment of subjects with PsA
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with PsA as defined by:
- •Presence of psoriasis with at least one 2 cm plaque AND
- •One of the five functional classifications of PsA
- •Functional Class I, II, or III as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis
- •Moderate to severe disease, defined as follows:
- •At least 3 tender and 3 swollen joints (78 joint count for tenderness and 76 joints for swelling; AND
- •Either ESR ≥ 28 mm/hr, CRP ≥ 1.5 mg/dL, or morning stiffness for ≥ 30 minutes.
- •Currently taking at least one of the following systemic therapies for PsA: pre-existing stable doses of NSAIDs, corticosteroids (≤ 10 mg/day), and either sulfasalazine (≤ 3 gm/day) or methotrexate (≥ 7.5 and ≤ 30 mg/week) but not both.
- •18 to 80 years of age.
- •Body weight ≤ 125 kg (275 lbs).
- •Candidate for systemic immunomodulatory therapy.
- •Using an acceptable method of birth control.
- •If female, must have a negative serum pregnancy test during screening period, must be surgically sterile, or must be at least five years postmenopausal.
- •Informed about the study and signed an informed consent prior to performance of any study-related procedure.
排除标准
- •Previous treatment with efalizumab.
- •Rheumatoid Factor positive without dactylitis or positive X-rays of the hands or feet, or with rheumatoid nodules.
- •History of joint replacement surgery within 60 days prior to the start of study drug dosing.
- •Joint replacement therapy planned within nine months subsequent to the start of study drug dosing.
- •Intra-articular cortisone injections within 28 days prior to the start of study drug dosing.
- •Pregnancy or lactation.
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Respiratory distress (dyspnea, oxygen desaturation with pO2 < 90% or onset of acute respiratory distress syndrome), flank or back pain, and/or hypotension may be signs of anaphylaxis.
- •Active bacterial, viral, fungal, mycobacterium tuberculosis or atypical mycobacterium infection.
- •Positive PPD test unless subject with positive PPD test completed a course of treatment for tuberculosis
- •History of any opportunistic infection.
- •History of a malignancy within the past five years. Subjects with a history of fully resolved, resected, basal or squamous cell carcinoma may be enrolled.
- •Received any vaccine within 28 days prior to the start of study drug dosing.
- •Chronic disorders apart from PsA affecting the joints, such as systemic lupus erythematosus, rheumatoid arthritis, gout, scleroderma or known reactive arthritis (e.g., Reiter's syndrome).
- •COPD, asthma, or other pulmonary disease requiring more therapy than using one inhaler 4× daily.
- •Failed to respond or maintain response to Enbrel.
- •Received any DMARD other than methotrexate or sulfasalazine during the 28 days prior to the start of study drug dosing.
- •Approved biologic PsA therapy during the 28 days or seven half-lives of the drug prior to the start of study drug dosing, whichever is the greater length of time; Enbrel within 42 days prior to the start of study drug dosing.
- •Investigational drug and/or treatment during the 28 days or 7 half-lives of the drug prior to the start of study drug dosing, whichever is the greater length of time.
- •Any condition which, in the opinion of the Investigator, would jeopardize the subject's safety following exposure to efalizumab.
- •Liver disease (e.g., hepatitis, cirrhosis) or abnormal hepatic function (AST or ALT ≥ 2.5
- •Serum creatinine level ≥ 1.5 mg/dL
- •Platelet count ≤ 125,000 cells/mm3
- •WBC count ≤ 3,500 cells/mm3
- •Total lymphocyte count ≤ 1000 cells/mm3
- •Seropositive for hepatitis B
- •Seropositive for hepatitis C antibody
- •Seropositive for HIV
- •Antinuclear antibodies titer ≥ 1:80
- •History of inflammatory bowel disease
研究组 & 干预措施
未命名试验
干预措施: efalizumab (Drug)
研究者
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