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

VUmc Neurology Department0 个研究点目标入组 100 人开始时间: 2020年4月9日最近更新: 2020年7月6日

研究概览

暂无简介。

•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 inclusion.
•4. Age 18 to 65 years old.
•5. EDSS score 3.0 – 7.0 (inclusive).
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. MS relapse within 6 months of baseline visit, with or without treatment with steroids.
•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.

发起方

VUmc Neurology Department