EUCTR2011-002068-26-IT进行中（未招募）不适用
A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG) - Evaluate the Use of Belimumab in Myasthenia Gravis (MG)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
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. Subjects aged 18 years and older, with life expectancy of greater than 1 year. 2. MG of class II to IVa inclusive. 3. Acetylcholine receptor (AChR) antibody positive. 4. Stable dose (defined as no dose changes) not exceeding the maximum doses given in Section 5.6.1 of protocol, the following therapy(ies) prior to screening: A. Cholinesterase inhibitor(pyridostigmine or equivalent) for at least 2 weeks prior to screening and no immunosuppressants; or B. Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to screening and/or only one of the following: i. prednisone (up to 40 mg/day or equivalent) for at least 1 month prior to screening, ii. azathioprine for at least 6 months prior to screening, iii. mycophenolate for at least 6 months prior to screening, or iv. cyclosporine for at least 3 months prior to screening; or C. Cholinesterase inhibitor (pyridostigmine or equivalent) for at least 2 weeks prior to screening and/or prednisone (up to 20 mg/day or equivalent) for at least 1 month prior to screening and only one of the following: i. azathioprine for at least 6 months prior to screening, ii. mycophenolate for at least 6 months prior to screening, or iii. cyclosporine for at least 3 months prior to screening 5. Quantitative Myasthenia Gravis (QMG) score of 8 or greater, with at least 4 points derived from signs other than ocular 6. A female subject is eligible to participate if she is: A. Of non-childbearing potential B. Of childbearing potential and NOT pregnant or nursing, has a negative serum pregnancy test at screening, and agrees to one of the following: a. Complete abstinence from penile-vaginal intercourse, when this is the female’s preferred and usual lifestyle, for the period from consent into the study until 16 weeks after the last dose of investigational product; or, b. Consistent and correct use of one of the following acceptable methods of birth control for the period from consent into the study until 16 weeks after the last dose of investigational product: i. Oral contraceptives (either combined or progesterone only) ii. Injectable progesterone iii. Implants of etonogestrel or levonorgestrel iv. Estrogenic vaginal ring v. Percutaneous contraceptive patches vi. Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of <1% per year vii. Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject’s entry into the study; this male must be the sole partner for the subject viii. Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent(foam/gel/film/cream/suppository). A female is considered Non-childbearing potential” if she is status-post hysterectomy, status-post surgical removal of both ovaries, has current, documented tubal ligation, or is postmenopausal and >2 years without menses. Female subjects who are post-menopausal <2 years must be confirmed menopausal by Follicle Stimulating Hormone (FSH) and estradiol levels. A female is considered childbearing potential” if she has functional ovaries, ducts, and uterus with no impairment that would cause sterility. This includes women with oligomenorrhea (even severe), and women who are perimenopausal or who have just begun to menstruate. 7. Capable of giving written informed consent, which includes compliance with the requiremen
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study: 1. The subject has participated in a clinical trial and has received an investigational product within 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) prior to screening or planning to take any investigational drug for the planned duration of study participation (6 months after the last dose of study drug). 2. Presence or previous history of thymoma. 3. Thymectomy within 12 months 4. Clinically significant (in the opinion of investigator) abnormal laboratory values. 5. Pregnant females as determined by positive (serum) hCG test at screening or prior to dosing, or lactating females or planning to become pregnant within 16 weeks after last dose of investigational product. 6. History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation. 7. May require (in the opinion of investigator) treatment with IVIg and/or plasmapheresis during the 24 week treatment period. 8. Have received IVIg and/or plasmapheresis within 90 days prior to screening. 9. Have received any other biopharmaceutical agent (except IVIg as described in exclusion criteria #8) in the 364 days prior to screening. 10. Have received treatment with any B cell targeted therapy (e.g., rituximab, belimumab), at any time. 11. Have received a live vaccine within 30 days of study Day 0 (baseline). 12. Have received cyclophosphamide or any other immunosuppressive agent apart from the ones allowed by the inclusion criteria #4, within the past 6 months. 13. Have another medical condition that requires treatment with steroids or immunosuppressive agents. 14. Hospitalization due to infection or use of parenteral antibacterial, antifungal or antiviral agents within 60 days prior to screening; or history of recurrent or chronic infection, or currently active systemic infection. 15. Have a history of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix. 16. Have a history of a major organ transplant (eg, heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant. 17. Have a historically positive test or test positive at screening for HIV-1, hepatitis B surface antigen or hepatitis C antibody. 18. Have an IgG Grade 3 or greater deficiency (= 400mg/dL). 19. Have an IgA deficiency (IgA < 10mg/dL). 20. Have a history of an anaphylactic reaction to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies. 21. The subject has a progressive medical, neurological or psychological condition or situation that, in the investigator’s judgment, is likely to cause the subject to be unable or unwilling to participate in study procedures, to complete all scheduled assessments, or precludes accurate assessments. 22. Is currently abusing drugs or alcohol or has history of abuse in the last 12 months. 23. Subjects who have evidence of serious suicide risk including any history of suicidal behavior in the last 6 months and/or any suicidal ideation of type 4 or 5 on the CSSRS (Appendix 4 of Protocol) in the last 2 months or who in the investigator's judgment, pose a significant suicide risk.
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