EUCTR2013-000594-69-ES进行中（未招募）不适用
A Dose-Blinded, 2-Dose Level, Parallel-Group, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Efficacy, and Immunogenicity of BIIB023 in Subjects with Lupus Nephritis - Unknown
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
- 220
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
- •To be eligible to participate in this study, candidates must meet the following eligibility criteria at Baseline (Day 1) or at the timepoint specified in the individual eligibility criterion listed:
- •1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations.
- •2. Subjects who completed Week 52 of Study 211LE201 and did not discontinue BIIB023 or placebo study treatment.
- •3. Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 6 months after their last dose of study treatment.
- •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 209
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •Candidates will be excluded from study entry if any of the following exclusion criteria exist at Baseline (Day 1) or at the timepoint specified in the individual criterion listed:
- •1. Any significant change in medical history in subjects from Study 211LE201, including laboratory tests or current clinically significant condition that, in the opinion of the Investigator, would have excluded the subjects? participation. The Investigator must re-review the subject?s medical fitness for participation and consider any diseases that would preclude treatment under this protocol.
- •2. Subjects from Study 211LE201 who discontinued BIIB023 or placebo treatment prior to Week 52 of Study 211LE201.
- •3. Female subjects considering becoming pregnant while in the study, currently pregnant, or breast feeding.
- •4. Previous participation in Study 211LE202; subjects who were enrolled in Study 211LE202 and consequently withdrew for any reason are prohibited from re-entering the study.
- •5. Unwillingness or inability to comply with the requirements of the protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject?s ability to comply with the protocol.
- •6. Subjects who were prescribed MMF >3 g/day during Study 211LE201 and/or subjects for whom the Investigator is planning to prescribe MMF >3 g/day during this study.
- •7. Subjects having received disallowed concomitant medication during Study 211LE201 including the following:
- •a. Immunosuppressant used for therapy of LN (cyclophosphamide, nitrogen mustard, chlorambucil, vincristine, procarbazine, etoposide, mycophenolic acid, azathioprine, cyclosporine, methotrexate, atacicept, or any biologic B-cell-depleting therapy (e.g., anti-CD20 [rituximab], anti-CD22 [epratuzumab], or anti-BLyS/B-cell activating factor [e.g., belimumab] therapy).
- •b. Treatment with Campath (alemtuzumab)
- •c. Anti-tumor necrosis factor (infliximab, adalimumab, etanercept, efalizumab or alefacept) treatment
- •d. Cyclophosphamide, calcineurin, or a calcineurin inhibitor (i.e., cyclosporine A or tacrolimus)
- •8. Subjects with the following laboratory test results at Week 48 of Study 211LE201:
- •a. Absolute neutrophil count <1.5 × 1000/?L
- •b. Platelet count <20,000/?L; subjects with platelet count >20,000/?L and <150,000/?L who are experiencing, or at high risk for developing, clinically significant bleeding or organ dysfunction requiring therapy (as determined by the Investigator)
- •c. Hemoglobin <8.5 g/dL
- •d. Aspartate aminotransferase/serum glutamate oxaloacetate transaminase or alanine aminotransferase/serum glutamate pyruvate transaminase >2 × upper limit of normal established by the central laboratory
- •9. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, makes the subject unsuitable for enrollment.
研究者
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