NL-OMON49976尚未招募2 期
Efficacy of add-on high-dose simvastatin on markers for disease progression in MS patients treated with ocrelizumab and natalizumab (SIMSON), a phase II clinical trial. - SIMSON trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Definite diagnosis of multiple sclerosis (MS) according to the revised
- •McDonald 2017 criteria.
- •2. Treatment with ocrelizumab or natalizumab for at least 6 months prior to
- •4. Age 18 to 65 years old.
- •5. EDSS score 3.0 - 7.0 (inclusive).
排除标准
- •1. MS relapse within 6 months of baseline visit, with or without treatment with
- •2. Use of immunomodulation or -suppression other than ocrelizumab or
- •natalizumab within the previous 6 months.
- •3. Commencement of treatment with fampridine within 3 months of baseline visit.
- •4. Concomitant use of lipid lowering drugs or use within 6 months before
- •baseline visit.
- •5. Concomitant use of potent CYP3A4 inhibitors.
- •6. (History of) hypersensitivity, muscular toxicity or other adverse reaction
- •due to statin or fibrate use.
- •7. Any predisposing factor to rhabdomyolysis: renal impairment (creatinine
- •clearance <70 mL/min), uncontrolled hypothyroidism, personal or familial
- •history of hereditary muscular disorders, alcohol abuse (>14 standard drinks
- •units per week).
- •8. Baseline serum creatine kinase (CK) levels of >5 x ULN (confirmed by second
- •measurement within 5-7 days), or at least 3-fold increase from baseline with
- •associated muscle symptoms.
- •9. Active liver disease or unexplained persistent elevations of serum
- •transaminases 3 x ULN.
研究者
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