NCT00541749已完成1 期
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Escalating Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of rhuMAb IFNalpha in Adults With Systemic Lupus Erythematosus
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- The incidence and nature of laboratory abnormalities
研究概览
简要总结
This is a Phase I, randomized, placebo-controlled, double-blind, dose-escalation study of single and repeat doses of rhuMAb IFNalpha, administered through the SC or IV route, in adults with Systemic Lupus Erythematosus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For patients with reproductive potential (males and females), use of a reliable means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, physical barrier) throughout their participation in the study
- •Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria
- •Disease duration of ≥ 1 year (after first diagnosis by a physician)
- •Current immunity to measles, mumps, rubella, and varicella, as evidenced by positive IgG titers at the time of screening
- •Current vaccination against influenza unless contraindicated in the investigator's judgment
- •Normal Pap smear within the applicable time interval recommended by current American Cancer Society guidelines
排除标准
- •Presence of active lupus nephritis
- •Presence of active central nervous system (CNS) disease requiring treatment with high-dose corticosteroids or immunosuppressive agents
- •Presence of active vasculitis requiring treatment
- •History of arterial or venous thromboses within 12 months of screening
- •Moderate to severe anemia, thrombocytopenia, or neutropenia
- •Any manifestation likely to require, in the investigator's judgment, treatment with high-dose corticosteroids or the addition of an immunosuppressive regimen during the course of the trial
- •Pregnancy or lactation
- •Lack of peripheral venous access
- •History of alcohol or substance abuse within 6 months of screening
- •History of severe allergic or anaphylactic reactions to antibodies or fusion proteins
- •Evidence of significant uncontrolled concomitant diseases
- •Significant laboratory or electrocardiogram (ECG) abnormalities
- •Evidence of any clinically significant abnormality on a chest X-ray
- •Severly impaired renal function
- •Impaired hepatic function
- •Poorly controlled diabetes
- •Conditions other than SLE that could require treatment with corticosteroids
- •History of malignancy except completely excised basal cell carcinoma
- •Congenital immune deficiency
- •Positive tests for antibodies to HIV, hepatitis B (HBS antigen, anti-HBC) or C
- •Positive IgM antibody titers in the presence of negative IgG titers to Epstein-Barr virus (EBV) or cytomegalovirus (CMV)
- •Frequent recurrence of herpes lesions
- •Episode of shingles within one year of screening
- •Positive screening test for latent mycobacterium tuberculosis infection
- •History of severe systemic bacterial, fungal, viral, or parasitic infections within the year prior to screening
- •Any current or recent signs or symptoms of infection
- •Received antibiotics orally (PO) during the 30 days prior to screening or IV antibiotics during the 60 days prior to screening
- •Received a live vaccine within the 30 days prior to screening
- •Has been hospitalized within the 30 days prior to screening
- •Received > 20 mg/day prednisone for > 3 days during the 30 days prior to screening
- •Received azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus, sirolimus, pulse dose corticosteroids, intravenous immunoglobulin (IVIG), or transfusions within 6 months prior to screening
- •Received cyclophosphamide within 2 years prior to screening
- •Received a monoclonal antibody during the 12 months prior to screening
- •Previously received an investigational treatment directed against interferon alpha
- •Received B-cell depleting therapy (e.g., anti-CD20, anti-CD22)
- •Received investigational treatment during the 30 days prior to screening
结局指标
主要结局
The incidence and nature of laboratory abnormalities
时间窗: Length of study
The incidence, nature, and severity of adverse events
时间窗: Length of study
次要结局
- The PK profile of rhuMAb IFNalpha(Length of study)
- The incidence of antibodies directed against rhuMAb IFNalpha(Length of study)
研究者
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