OCTAGON: A Phase 4, Single Arm Study to Investigate Oral Corticosteroid Tapering in Adult Patients With Generalized Myasthenia Gravis Treated With Ravulizumab
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 12
- 主要终点
- Proportion of Adult Participants With gMG Who Either: Discontinue Oral Corticosteroids (OCS) or Reduce Their Daily OCS Dosage ≤ 5 mg/day and Maintain this Status for ≥ 4 Weeks Without Clinical Deterioration of gMG
研究概览
简要总结
This is a prospective, multicenter single arm study designed to evaluate the effectiveness and safety of a predefined oral corticosteroids (OCS) tapering schedule to reduce OCS use in adult participants with acetylcholine receptor positive (AChR+) generalized myasthenia gravis (gMG) being treated with intravenous ravulizumab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged greater than 18 years and male or female
- •Clinical diagnosis of gMG
- •Receiving ravulizumab treatment prior to enrollment
- •Receipt of OCS therapy equivalent to a daily dose ≥ 7.5 mg of prednisone/prednisolone for ≥ 4 continuous weeks directly preceding enrollment
- •A participant of childbearing potential must have a negative highly sensitive pregnancy test (serum or urine, as required by local regulations) taken at Screening before OCS tapering begins.
- •Willing to sign informed consent
排除标准
- •Concurrent participation in an interventional clinical trial.
- •History of chronic hypoadrenalism (ie, Addison's disease).
- •Use of concomitant OCS for comorbid conditions other than gMG
- •Receipt of a biologic for gMG (e.g., efgartigimod, rozanolixizumab, inebilizumab, rituximab, intravenous immunoglobulin) within 5 half-lives of enrollment
- •Pregnant, breastfeeding, or intending to conceive during the course of the study
研究组 & 干预措施
Oral Corticosteroid Tapering Schedule
During the tapering period, participant will follow an Oral Corticosteroid tapering schedule until OCS tapering is complete
干预措施: Oral Corticosteroid Tapering Schedule (Procedure)
Oral Corticosteroid Tapering Schedule
During the tapering period, participant will follow an Oral Corticosteroid tapering schedule until OCS tapering is complete
干预措施: Prednisone/Prednisolone (Drug)
Oral Corticosteroid Tapering Schedule
During the tapering period, participant will follow an Oral Corticosteroid tapering schedule until OCS tapering is complete
干预措施: Ravulizumab (Drug)
结局指标
主要结局
Proportion of Adult Participants With gMG Who Either: Discontinue Oral Corticosteroids (OCS) or Reduce Their Daily OCS Dosage ≤ 5 mg/day and Maintain this Status for ≥ 4 Weeks Without Clinical Deterioration of gMG
时间窗: Up to approximately 32 weeks
次要结局
- Proportion of Adult Participants with gMG Who Discontinue OCS (0 mg/day), Sustained ≥ 4 Weeks Without Clinical Deterioration of gMG(Up to approximately 32 weeks)
- Percentage Change From Daily OCS Dose (mg/day) at Baseline(Baseline, Up to approximately 32 weeks)
- Change from Baseline in the Myasthenia Gravis Quality of Life-15 Revised (MG-QoL-15r) Score in Adult Participants with gMG(Baseline, Up to approximately 32 weeks)
- Change from Baseline in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score in Adult Participants with gMG(Baseline, Up to approximately 32 weeks)
- Cumulative Worsening Score per the Glucocorticoid Toxicity Index - Metabolic Domains (GTI-MD) in Adult Participants with gMG(Baseline up to approximately 32 weeks)
- Aggregate Improvement Score per the GTI-MD in Adult Participants with gMG(Baseline up to approximately 32 weeks)