NCT00004662已完成3 期
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Active Systemic Lupus Erythematosus
National Center for Research Resources (NCRR)0 个研究点目标入组 300 人开始时间: 1996年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
OBJECTIVES:
I. Evaluate the safety and efficacy of synthetic dehydroepiandrosterone, GL701, in women with active systemic lupus erythematosus.
详细描述
PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution.
Patients are randomly assigned to daily oral dehydroepiandrosterone or placebo for 52 weeks. Patients are evaluated every 13 weeks on study and return for a follow-up 6 weeks after completion of therapy.
Concurrent therapy with estrogen replacement and stable doses of prednisone, azathioprine, methotrexate (with folate supplementation), hydroxychloroquine, and nonsteroidal anti-inflammatory drugs is allowed. Other investigational medications and immunosuppressants are prohibited.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Systemic lupus erythematosus by 1982 American College of Rheumatology criteria Diagnosed for at least 6 months
- •Systemic Lupus Activity Measure score at least 7 Points for erythrocyte sedimentation rate excluded
- •SLEDAI score of greater than 2 at both screening and qualifying visits
- •-Prior/Concurrent Therapy--
- •No prior participation in any dehydroepiandrosterone (DHEA) study
- •No investigational agent within the longer of 30 days or 10 half-lives of the agent
- •Prednisone (or equivalent) dose 0 to 10 mg/day Unchanged for at least 6 weeks prior to entry
- •At least 3 months since immunosuppressants other than azathioprine and methotrexate, including:
- •Adrenocorticotropin hormone
- •Androgens
- •Cyclophosphamide
- •Cyclosporine
- •Immune globulin
- •At least 6 weeks since change in azathioprine, methotrexate, or hydroxychloroquine
- •-Patient Characteristics-- Renal: No requirement for hemodialysis
- •Cardiovascular: No serious abnormality on electrocardiogram
- •No hypersensitivity to DHEA or inactive ingredients in GL701 formulation, i.e., cornstarch, lactose, or magnesium stearate
- •No history of breast cancer or reproductive tract malignancy
- •Cervical carcinoma eligible if surgically cured, i.e., no evidence of disease for 5 years
- •No condition that would prevent compliance or follow-up, e.g.: Alcoholism Drug addiction Acute withdrawal from chemical dependency
- •Psychiatric disease
- •No pregnant or nursing women
- •Negative pregnancy test required of fertile women
- •Reliable contraception required of fertile women
- •No estrogen-containing oral contraceptives on study
- •At least 3 weeks since estrogen-containing oral contraceptives
排除标准
- 未提供
研究者
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