EUCTR2012-001645-41-EE进行中（未招募）1 期
An adaptive Phase II study to evaluate the efficacy, pharmacodynamics, safety and tolerability of GSK2586184 in patients with active systemic lupus erythematosus.
GlaxoSmithKline Research and Development Limited0 个研究点目标入组 50 人开始时间: 2012年11月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- •Subjects eligible for enrolment in the study must meet all of the following criteria:
- •1. Age and Gender: Male or female between 18 and 75 years of age inclusive, at the time of signing the informed consent.
- •2. SLE classification: Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria, with 4 or more of the 11 ACR criteria present, serially or simultaneously during any interval or observation.
- •3. Severity of disease: Have clinically active SLE disease defined as a SELENA SLEDAI score =8 at screening during the 35-day screen period.
- •4. Auto antibodies: Are serologically active having unequivocally positive antinuclear antibody (ANA) or anti-double stranded DNA (anti-dsDNA) antibody test results from 2 independent time points as follows:
- •Positive test results from 2 independent time points within the study screening period. Screening results must be based on the study’s central laboratory results. A positive test is defined as a positive ANA test equivalent to a titre =1:80 as defined in the central laboratory manual and/or a positive anti-dsDNA (=30 IU/mL) serum antibody.
- •One positive historical test result and 1 positive test result for either ANA or anti-dsDNA during the screening period.
- •Historical documentation of a positive test of ANA (e.g., ANA by HEp-2 titre) or anti-dsDNA antibody (e.g., anti-dsDNA by Farr assay) must include the date and type of the test, the name of the testing laboratory, numerical reference range, and a key that explains values provided as positive vs. negative OR negative,
- •equivocal/borderline positive). Only unequivocally positive values as defined in the laboratory’s reference range are acceptable; borderline values will not be accepted.
- •5. Treatment for SLE: patient stable on either no treatment or on a stable dose of corticosteroids (=15mg/day prednisone or prednisone equivalent or less) stable for a minimum of 30 days prior to screening and through to Day 0/Randomisation and /or an anti-malarial therapy[hydroxychloroquine (=400mg daily dose) or chloroquine (= 500mg daily dose) or quinacrine ( =100mg daily dose)]for a minimum of 60 days prior to the Day 0/Randomisation Visit. Subjects receiving azathioprine (= 2mg/kg/day or = 150mg/day, whichever is greater) or mycophenolate mofetil (= 1.5g/day), or MTX (=20mg/week), either alone or in addition to steroids and / or an anti-malarial therapy as described above, if they have been on a stable dose of azathioprine OR
- •mycophenolate mofetil OR MTX for a minimum of 90 days prior to the Day 0 /Randomisation Visit.
- •For those subjects on alternating day dosing of steroids, use the average of 2 daily doses to calculate the average daily steroid dose.
- •6. ECG: Single QTc, < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
- •7. Prevention of Pregnancy:
- •Females: A female subject is eligible to participate if she is not pregnant, as confirmed by a negative serum human chorionic gonadotrophin (hCG) test, or lactating and at least one of the following conditions applies: Please refer to page 41 bullet point 7 of the study protocol for details.
- •8. Informed consent: Capable of giving written informed consent, including confirmation that the subject is not mentally or legally incapacitated, and compliance with the requirements and restrictions listed in the consent form.
- •French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated t
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •1. Kidney Disease
- •2. CNS Disease
- •3. Alcohol Abuse
- •4. Substance Abuse
- •5. Hepatitis B
- •6. Hepatitis C
- •8. Previous investigational product exposure
- •9. Previous and current medication
- •10. Prior biological therapies
- •11. Transplantation
- •12. Uncontrolled Other Diseases
- •13. Surgery and Other Conditions
- •14. Cancer
- •15. Infections
- •16. Mycobacterium Tuberculosis
- •17. Haematology
- •18. Serum immunoglobulin (Ig) levels
- •19. Liver Function Tests
- •20. Other laboratory abnormalities
- •21. Drug sensitivity
- •22. Blood donation
- •* Please refer to the study protocol section 5.3 Exclusion Criteria pages 43-44 for further details.
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