A Dose Blinded Extension Study to the CBAF312A2201 Study to Evaluate Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally Once Daily in Patients With Relapsing-remitting Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout)
研究概览
简要总结
This study consisted of a two year dose blinded phase during which patients received one of five doses of siponimod (10, 2, 1.25, 0.5 or 0.25mg) following which patients were switched to open label treatment with siponimod 2mg for approximately a further 3 years. It will provide data on long term safety, tolerability and efficacy of siponimod in the RRMS patient population
详细描述
This study was prematurely discontinued after approximately 5 years. The decision to prematurely discontinue the study was not taken due to safety-related concerns, rather due to a decision to focus the development of siponimod in MS on a different population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masking continued during the double blind period of extension only.
入排标准
- 年龄范围
- 18 Years 至 56 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients completed the core study BAF312A2201
- •Written informed consent provided before any assessment of the extension study
- •Female patients at risk of becoming pregnant must have a negative pregnancy test and use simultaneously two forms of effective contraception
排除标准
- •Newly diagnosed systemic disease other than MS (which may require immunosuppressive treatment)
- •Malignancies, diabetes, significant cardiovascular and pulmonary diseases and conditions
- •Active infections
研究组 & 干预措施
BAF312 10 mg/2 mg
10 mg dose in Double Blind Phase and 2 mg in Open Label Phase
干预措施: BAF312 (Drug)
BAF312 2 mg/2 mg
2 mg dose in Double Blind Phase and 2 mg in Open Label Phase
干预措施: BAF312 (Drug)
BAF312 1.25 mg/2 mg
1.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
干预措施: BAF312 (Drug)
BAF312 .5 mg/2 mg
.5 mg dose in Double Blind Phase and 2 mg in Open Label Phase
干预措施: BAF312 (Drug)
BAF312 .25 mg/2 mg
.25 mg dose in Double Blind Phase and 2 mg in Open Label Phase
干预措施: BAF312 (Drug)
结局指标
主要结局
Number of Participants With Cardiac Conduction Abnormalities During the Titration Phase of the Study (Without Washout)
时间窗: Baseline Extension up to day 10
Number of patients with abnormal ECG conduction findings during dose-blinded titration at any visit post-dose, by type of abnormality and treatment (Extension Set). Number analyzed represent participants who had ECG results. Washout was defined as not being on treatment drug between Core and Extension for \>7 days. Abbreviation: Con=conduction, IVCD=intraventricular conduction defect , WPW=Wolff-Parkinson-White syndrome
Number of Participants With Cardiac Conduction-IVCD Abnormality During the Titration Phase of the Study (With Washout)
时间窗: Baseline Extension up to day 10
Number of patients with abnormal ECG conduction findings during dose-blinded titration at any visit post-dose, by type of abnormality and treatment (Extension Set). Number analyzed represent participants who had ECG results. Washout was defined as not being on treatment drug between Core and Extension for \>7 days. Abbreviations: washout = WO, Con=conduction
Total Number of Adverse Events During Evaluation of Long Term Safety and Tolerability of BAF312A in Extension Study.
时间窗: Baseline up to approximately 5 years
Refer to adverse events for complete listing of serious adverse events and other adverse events. Adverse events of interest were presented in separate tables. There were no reports of macular edema.
Number of Participants With Changes in Blood Pressure for Overall Extension Study. (Extension Analysis Set)
时间窗: Baseline Extension up to approximately 5 years
Sitting blood pressure was measured in triplicate. The categories of notably low and high values and changes are presented for systolic (SBP) and diastolic (DBP). Multiple occurrences for a patient are counted as one occurrence in this table.
Number of Participants With Viral Infections of Interest Greater or Equal to 5% in Any Dose Group (Extension Set)
时间窗: Baseline Extension up to approximately 5 years
Most infections were clinical diagnoses and were not confirmed by microbiology / virologic investigations. A patient with multiple occurrences of an infection for a preferred term is counted only once in each specific category. Events identified as infections by the Investigator and defined as an AE with onset on or after the first dose of Extension Study drug up to and including 30 days after the date of the last dose
Number of Participants With Dermatologic Alterations - Basal Cell Carcinoma (Extension Set)
时间窗: Baseline Extension up to approximately 5 years
次要结局
- Number of Relapses in One Year - Annualized Relapse Rates for Overall Extension Study (ARR) (Extension Set)(Baseline extension up to approximately 5 years)
- Percentage of Participants Free of Confirmed Disability Progression in Extension Study (Extension Set)(Baseline Extension up to approximately 5 years)
- Percentage of Participants Free of Magnetic Resonance Imaging (MRI) Identified Disease Activity at Any Scan During Extension Study (Extension Set)(Baseline Extension up to approximately 5 years)