2024-513475-41-00招募中3 期
DISEASE MODIFYING THERAPIES WITHDRAWAL IN INACTIVE RELAPSING-REMITTING MULTIPLE SCLEROSIS PATIENTS AGED 55 AND OVER: A MULTICENTRIC, RANDOMIZED, CONTROLLED, OPEN-LABEL CLINICAL TRIAL - TWINS
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 21
- 主要终点
- Time to first clinical and/or radiological disease activity during a period of 2 years.
研究概览
简要总结
To demonstrate the non-inferiority in disease activity-free survival between continuation and discontinuation of treatment in stable RRMS patients aged 55 and over. These results could lead to a modification of the standard care protocol to meet the needs of older populations.
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
- •Patient (male or female) aged 55 and over
- •RRMS (Relapsing-Remitting Multiple Sclerosis) diagnosis according to revised McDonald 2017 criteria
- •First MS symptom > 5 years ago. If the date is unknown, RRMS diagnosis > 5 years ago
- •Stable disease in the last 5 years according to the revised Lublin and Reingold classification 19 characterized by : a. Stable T2 lesions documented by MRI performed at least 5 years prior to inclusion versus MRI performed within 6 months prior to the inclusion visit, AND b. Stable EDSS documented at least 5 years prior to inclusion versus EDSS documented within 6 months prior to inclusion visit, according to the investigator's judgment, AND c. The absence of relapses within 5 years prior to the inclusion visit
- •Treated with a Moderate Efficacy Therapy (MET) for at least 5 consecutive years (IFN-β, glatiramer acetate, dimethyl fumarate, teriflunomide, diroximel fumarate); switching from one first-line treatment to another is accepted if the reason for the change is related to personal convenience or intolerance to the first treatment.
排除标准
- •Primary progressive or secondary progressive with or without relapse as defined by the revised Lublin and Reingold classification
- •Previous or ongoing treatment with a High Efficacy therapy (HET), with the exception of induction therapy (mitoxantrone, stem cell transplantation, alemtuzumab) provided that the last administration took place at least 10 years prior to inclusion
- •Contraindication to MRI (claustrophobia, weight ≥ 140 kg, pacemaker, cochlear implants, foreign body in eye, intracranial vascular clips, surgery in the 6 weeks prior to the beginning of the study, coronary stent implanted in the 8 weeks prior to the beginning of the study,…). NB: Gadolinium contraindication will not prevent recruitment of the patient; in this case MRI will be carried out without contrast product injection
- •History of neurological disease affecting the central nervous system: hereditary degenerative CNS disease, degenerative cognitive disease, systemic autoimmune disease, sarcoidosis, Lyme disease…
- •Chronic disease which requires chronic treatment with corticoids or immunosuppressors
- •Uncontrolled cardiac, renal or hepatic disease
结局指标
主要结局
Time to first clinical and/or radiological disease activity during a period of 2 years.
Time to first clinical and/or radiological disease activity during a period of 2 years.
次要结局
- Secondary endpoints will be measured by comparing baseline scores/evaluations (M0) with the scores/evaluations at M6, M12, M18, and M24: 1. Kaplan Meier analysis of time to relapse
- 2. Annual relapse rate (ARR)
- 3. Transition to secondary progressive multiple sclerosis according to revised McDonald 2017 criteria
- 4. Scores at EDSS, 25Foot/Walk, 9-HPT tests
- 8. MS comorbidities questionnaire
- 5. Scores at CSCT questionnaire
- 6. Scores at SEP-59, EQ-5D, Hospital Anxiety and Depression (HAD) and Burden of Treatment (TBQ) Questionnaires
- 7. Safety of treatments will be followed by the number and type of adverse or severe adverse events (AE/SAE) throughout the protocol ; Clinical examination, patient questioning; biological analysis in the case of suspected infection
- 9. Average annual cost, incremental ratio cost/effectiveness and cost/utility ratios
研究者
Nicolas COLLONGUES
Scientific
Les Hopitaux Universitaires De Strasbourg
研究点 (21)
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