EUCTR2014-003162-25-DE进行中（未招募）1 期
Mepolizumab Long-term Access Programme for Subjects who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis with Polyangiitis in Subjects Receiving Standard-of-care Therapy)
GlaxoSmithKline Research Ltd0 个研究点目标入组 115 人开始时间: 2014年12月9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
- 115
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
- •[1] MEA115921 PARTICIPATION
- •1. Subject participated in study MEA115921
- •[2] MEA115921 COMPLETION
- •2. Subject has either:
- •i. completed study MEA115921 to Week 60, i.e., completion of follow up period,
- •ii. if the subject was withdrawn prematurely from study MEA115921, the subject has reached the date of what would have been the Week 60 if the subject had completed the study, i.e., 60 weeks from Baseline (Visit 2).
- •[3] SUBJECT REQUIRES PREDNISOLONE (OR EQUIVALENT)=>5 MG/DAY
- •3. At or up to 6 months after the MEA115921 Week 60 time- point the subject requires a dose of prednisolone (or equivalent) of =>5 mg/day for adequate control of their EGPA.
- •Note: Inclusion of subjects >6 months after the MEA115921 Week 60 time-point will be considered on an individual subject basis by the GSK Medical Monitor.
- •[4] PHYSICIAN ASSESSMENT SUPPORTS MEPOLIZUMAB TREATMENT
- •4. The treating physician requesting mepolizumab under this Long-term Access Programme considers the benefits of treatment with mepolizumab outweigh the risks for the individual subject.
- •[5] FEMALE SUBJECTS
- •5. To be eligible for mepolizumab treatment under this Long-term Access Programme, females of childbearing potential (FCBP) must commit to consistent and correct use of an acceptable method of birth control, as summarised in Appendix 3, beginning with consent, for the duration of the treatment with mepolizumab and for 4 months after the last mepolizumab administration.
- •[6] INFORMED CONSENT
- •6. The subject consents to receiving treatment with mepolizumab under this Long-term Access Programme.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •[1] MALIGNANCY
- •1. A current malignancy or history of cancer in remission for less than 12 months (Subjects who had localized carcinoma (i.e., basal or squamous cell) of the skin which was resected for cure will not be excluded).
- •[2] OTHER CLINICALLY SIGNIFICANT MEDICAL CONDITIONS
- •2. Subject has other clinically significant medical conditions uncontrolled with standardof- care therapy not associated with EGPA, e.g., unstable liver disease, uncontrolled cardiovascular disease, ongoing active infectious disease requiring systemic
- •[3] PREGNANCY
- •3. Subject is pregnant or breastfeeding. Subjects should not be considered for continued treatment if they plan to become pregnant during the course of treatment with mepolizumab.
- •[4] HYPERSENSITIVITY
- •4. Subject has a known allergy or intolerance to a monoclonal antibody or biologic therapy including mepolizumab.
- •[5] PREMATURE WITHDRAWAL OF STUDY TREATMENT IN MEA115921
- •5. Subject had an adverse event (serious or non-serious) considered related to study treatment whilst participating in study MEA115921 which resulted in permanent withdrawal of study treatment.
- •[6] OTHER BIOLOGICAL THERAPY
- •6. Subject is receiving treatment with another biological therapy such as a monoclonal antibody therapy or IV immunoglobulin therapy without prior agreement from the GSK Medical Monitor.
- •[7] OTHER INVESTIGATIONAL PRODUCTS
- •7. Subjects who have received treatment with an investigational drug within the past 30 days or 5 terminal phase half-lives of the drug whichever is longer, prior to initiation of mepolizumab treatment under this Long-term Access Programme (this
- •also includes investigational formulations of marketed products).
- •[8] OTHER CLINICAL STUDY
- •8. Subject is currently participating in any other interventional clinical study.
研究者
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