EUCTR2010-020328-23-EE进行中（未招募）不适用
A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with 44 µg tiw of Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merck Serono
- 入组人数
- 230
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Diagnosis of a relapsing-remitting form of MS
- •Brain and/or spinal MRI with findings typical of MS
- •A first clinical event prior to Screening.
- •Disease activity
- •EDSS score of less than, or equal to 4.0 at Screening.
- •Currently treated with interferon-beta-1a 44µg (tiw) sc
- •Willingness and ability to comply with the protocol
- •Written informed consent
- •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 230
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Pregnancy and lactation period
- •Any disease other than MS that could better explain signs and symptoms.
- •Complete transverse myelitis or bilateral optic neuritis.
- •Currently receiving or use at any time of monoclonal antibodies, mitoxantrone, cytotoxic or immunosuppressive therapy (excluding systemic steroids and adrenocorticotrophic hormone [ACTH]), B cell modulating therapies (e.g. RituxiMab or BelimuMab), total lymphoid irradiation or bone marrow transplantation.
- •Use of any cytokine (other than interferon) or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, or any investigational drug or experimental procedure
- •Use of oral or systemic corticosteroids or ACTH
- •Have abnormalities of Vitamin D related hormonal system other than low dietary intake or decreased sun exposure, i.e. primary hyperparathyroidism or granulomatous disorders.
- •Have an urine calcium/creatinine (mmol/mmol) ratio greater than 1.0 or hypercalcaemia
- •Are taking medications that influence Vitamin D metabolism other than corticosteroids, e.g., phenytoin, barbiturates, thiazide diuretics and cardiac glycosides.
- •Are taking more than 1000 IU (25 µg) of Vitamin D supplement daily.
- •Have conditions with increased susceptibility to hypercalcaemia, e.g., known arrhythmia or heart disease, treatment with Digitalis, or Hydrochlorothiazide and those who suffer from nephrolithiasis.
- •Have inadequate liver function
- •Moderate to severe renal impairment
- •Inadequate bone marrow reserve
- •History or presence of serious or acute heart disease such as uncontrolled cardiac dysrhythmia or arrhythmia, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure (NYHA class 3 or 4).
- •History or presence of severe depression, history of suicide attempt, or current suicidal ideation.
- •Epilepsy or seizures not adequately controlled by treatment.
- •Current or past alcohol or drug abuse.
- •Any major medical or psychiatric illness (such as psychosis, bipolar disorder) that in the opinion of the Investigator could create undue risk to the subject or could affect adherence with the trial protocol.
- •Known contra-indication to treatment with vitamin D
- •Known hypersensitivity to interferon or its excipient(s)
- •Known hypersensitivity to gadolinium.
- •Any other condition that would prevent the subject from undergoing an MRI scan.
- •Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
- •Positive HIV, hepatitis C, or hepatitis B (HBsAg and HBc antibody) serology (test performed at screening).
- •Legal incapacity or limited legal capacity.
- •Another current autoimmune disease, except diabetes.
研究者
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