2024-516628-32-00招募中3 期
STOP-I-SEP_Disease modifying therapies withdrawal in inactive Secondary Progressive Multiple Sclerosis patients older than 50 years
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 24
- 主要终点
- Percentage of patients experiencing disability progression (confirmed at 6 months) at 2 years. Disability progression will be defined as an increase in the EDSS of at least 1 point if the baseline EDSS was 5.5 or less, or 0.5 point if the Baseline EDSS was more than 5.5.
研究概览
简要总结
To demonstrate the non-inferiority of DMTs withdrawal compared to treatment continuation at 2 years, on disability progression, in “inactive” SPMS patients older than 50 years. The definition of “inactive” SPMS patients refers to the Lublin classification : SPMS patients without recent evidence of focal inflammatory activity for at least 3 years (no clinical relapse and no radiological activity)
研究设计
- 分配方式
- Randomized
- 主要目的
- M0-m24
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 50 years old
- •Secondary progressive phenotype for at least 3 years ; The secondary progressive phenotype will be defined as progressive deterioration of disability not due to relapse, with an increase of at least 1 EDSS point since the beginning of the progressive phase (or 0.5 EDSS point if EDSS score > 5.5)
- •Disease modifying therapy of MS for at least 3 years (interferon, glatiramer acetate, teriflunomide, dimethyl fumarate, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil, rituximab, ocrelizumab); Both patients with the same DMT or with successive DMTs during 3 years can be included. It is important to note that patients could have been treated with fingolimod or natalizumab 2 or 3 years before inclusion, but not during the year before inclusion
- •No evidence of focal inflammatory activity for at least 3 years (no clinical relapse and no gadolinium enhancement on an MRI scan)
排除标准
- •Patients treated with mitoxantrone or alemtuzumab, during the previous 3 years before inclusion
- •Patients treated with natalizumab or fingolimod during the year before inclusion
- •Change of disease modifying therapy of MS for less than a year
- •Other neurological or systemic disease
- •Incapacity to understand or sign the consent form
- •Contraindication to MRI
- •Pregnancy or breast-feeding
- •Patient in another clinical trial
- •Persons referred to in Articles L. 1121-5 to L. 1121-8 and L. 1122-1-2 of the Public Health Code (eg minors, protected adults, …)
结局指标
主要结局
Percentage of patients experiencing disability progression (confirmed at 6 months) at 2 years. Disability progression will be defined as an increase in the EDSS of at least 1 point if the baseline EDSS was 5.5 or less, or 0.5 point if the Baseline EDSS was more than 5.5.
Percentage of patients experiencing disability progression (confirmed at 6 months) at 2 years. Disability progression will be defined as an increase in the EDSS of at least 1 point if the baseline EDSS was 5.5 or less, or 0.5 point if the Baseline EDSS was more than 5.5.
次要结局
- Relapses - Percentage of patients with at least one relapse from baseline to 2-year; - Annualized relapse rate during 2-year; - Time from DMT withdrawal to first relapse;
- Disability - Time from DMT withdrawal to disability progression confirmed at 6 months; - Change in a composite disability progression score (increase in the EDSS score, or an increase in the time to perform the timed 25-foot walk ≥ 20%, or an increase in the time to complete the 9-hole peg test ≥ 20%) confirmed at 6 months; - Change in the SDMT score from baseline to 2-year;
- MRI - Percentage of patients with one or more new or enlarging brain MRI lesions from baseline to 2-year; - Percentage of patients with at least one gadolinium enhancing lesion(s) at 6 months, and/or 1 year,and/or 2-year; - Change in brain volume from baseline to 2-year;
- Disease free survival - Percentage of patients with no evidence of disease activity (NEDA 3: no clinical relapse, no MRI activity, no disability progression) at 2-year; - Percentage of patients who resume DMT in the treatment withdrawal group at 2-year
- Quality of life - Change in the SEP-59 score from baseline to 2-year; - Change in the EuroQOL EQ-5D from baseline to 2-year;
- Medico economic impact - Incremental Cost Effectiveness Ratio (ICER) defined as the cost for QALY gained in “treatment withdrawal group” versus “treatment continued group”.
研究者
Dr Anne KERBRAT
Scientific
Centre Hospitalier Universitaire De Rennes
研究点 (24)
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