EUCTR2010-020328-23-NL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 Rebif®SOLARSupplementation of VigantOL® Oil versus Placebo as Add-on in Patients with Relapsing-Remitting MS receiving Rebif® treatment. - SOLAR
Merck Serono The Netherlands - a division of Merck B.V.0 个研究点目标入组 358 人开始时间: 2010年9月16日最近更新:
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试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 358
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
- •For inclusion in the trial, subjects with either inpatient or outpatient status must fulfill all of the following inclusion criteria by:
- •1. Males and females between 18 and 50 years of age.
- •2. Diagnosis of a relapsing-remitting form of MS, according to the revised McDonald criteria (2005).
- •3. Brain and/or spinal MRI with findings typical of MS.
- •4. A first clinical event occurring within 5 years prior to Screening.
- •5. Disease activity characterized by:
- •a) At least one MS lesion within the 12 months prior to Screening,
- •b) One or more Gd-enhancing MRI lesions within the 12 months prior to Screening.
- •6. EDSS score 7. Currently and for the first time treated with interferon-beta-1a (tiw) s.c., and having received this treatment for a minimum of 90 days and for not longer than 12 months before baseline visit (including titration period).
- •8. Willingness and ability to comply with the protocol for the duration of the trial.
- •9. Written informed consent given prior to any trial-related procedure not part of the normal medical practice.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects are not eligible for this trial if they fulfill any of the following exclusion criteria:
- •1. Pregnancy and lactation period
- •2. Any disease other than MS that could better explain signs and symptoms.
- •3. Complete transverse myelitis or bilateral optic neuritis.
- •4. 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.
- •5. Use of any cytokine or anti-cytokine therapy, intravenous immunoglobulin, plasmapheresis, or any investigational drug or experimental procedure within 12 months prior to Screening.
- •6. Use of oral or systemic corticosteroids or ACTH within 30 days prior to the SD1 visit.
- •7. Have experienced a relapse within 30 days before the SD1 visit
- •8. Have abnormalities of Vitamin D related hormonal system other than low dietary intake or decreased sun exposure, i.e. primary hyperparathyroidism or granulomatous disorders.
- •9. Have a urine calcium/creatinine (mmol/mmol) ratio greater than 1.0 or hypercalcemia (11 mg/100cc (5.5 mEq/L)).
- •10. Are taking medications that influence Vitamin D metabolism other than corticosteroids, i.e., phenytoin, barbiturates, thiazide diuretics and cardiac glycosides.
- •11. Have conditions with increased susceptibility to hypercalcemia, e.g., known arrhythmia or heart disease, treatment with Digitalis, or Hydrochlorothiazide and those who suffer from nephrolithiasis.
- •12. Have inadequate liver function, defined by alanine aminotransferase (ALT) > 3 times upper limit of normal (ULN), aspartate aminotransferase (AST) > 3 times ULN or alkaline phosphatase > 2.5 times ULN, or total bilirubin > 1.5 times ULN, if associated with any elevation of ALT or alkaline phosphatase
- •13. Moderate to severe renal impairment (estimate of glomerular filtration rate [GFR] < 50 mL/min/1.73 m2 [based on creatinine clearance according to Cockcroft-Gault equation])
- •14. Inadequate bone marrow reserve, defined by a WBC count < 0.5 times the lower limit of normal.
- •15. 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).
- •16. History or presence of severe depression, history of suicide attempt, or current suicidal ideation.
- •17. Epilepsy or seizures not adequately controlled by treatment.
- •18. Current or past (within the last 2 years) alcohol or drug abuse.
- •19. 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.
- •20. Known contra-indication to treatment with vitamin D (according to SPC)
- •21. Known hypersensitivity to IFN or its excipient(s) (according to SPC).
- •22. Known hypersensitivity to gadolinium.
- •23. Any other condition that would prevent the subject from undergoing an MRI scan.
- •24. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such.
- •25. Positive HIV, hepatitis C, or hepatitis B (HBsAg and HBc antibody) serology (test performed at screening).
- •26. Legal incapacity or limited legal capacity.
- •27. Another current autoimmune disease, except diabetes.
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