EUCTR2010-020328-23-IT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 (SOLAR) - 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）
- 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
- •1. Be males or females between 18 and 50 years of age 2. Have relapsing-remitting form of MS, according to the revised McDonald criteria 2005 3. Have brain and/or spinal MRI with findings typical of MS 4. Have had the first clinical event within 5 years prior to Screening 5. Have experienced at least one clinical event or one Gd-enhancing MRI lesion in the last 12 months before the Screening visit 6. Have score ? 4.0 on the EDSS at Screening 7. Currently and for the first time treated with interferon-beta-1a (tiw) s.c., and having received this treatment a minimum of 90 days and for not longer than 12 months before baseline visit (including titration period) 8. Be willing and able to comply with the protocol 9. Provide written informed consent prior to any trial related procedures
- •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
- •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, e.g. primary hyperparathyroidism or granulomatous disorders. 9. Have a urine calcium/creatinine (mmol/mmol) ratio greater than 1.0 or hypercalcaemia (11 mg/100cc (5.5 mEq./l.). 10. Are taking medications that influence Vitamin D metabolism other than corticosteroids, e.g., phenytoin, barbiturates, thiazide diuretics and cardiac glycosides. 11. Are taking more than 400 IU (10 ?g) of Vitamin D supplement daily. 12. 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. 13. Have inadequate liver function, defined by alanine aminotransferase (ALT) > 3 times upper limit of normal (ULN), aspartate aminotransferase (AST) > 3 times upper limit of normal (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 14. 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]) 15. Inadequate bone marrow reserve, defined by a WBC count < 0.5 times the lower limit of normal. 16. 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). 17. History or presence of severe depression, history of suicide attempt, or current suicidal ideation. 18. Epilepsy or seizures not adequately controlled by treatment. 19. Current or past (within the last 2 years) alcohol or drug abuse. 20. 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. 21. Known contra-indication to treatment with vitamin D (according to SPC) 22. Known hypersensitivity to IFN or its excipient(s) (according to SPC). 23. Known hypersensitivity to gadolinium. 24. Any other condition that would prevent the subject from undergoing an MRI scan. 25. Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such. 26. Positive HIV, hepatitis C, or hepatitis B (HBsAg and HBc antibody) serology (test performed at screening). 27. Legal incapacity or limited legal capacity. 28. Another current autoimmune disease, except diabetes.
研究者
相似试验
尚未招募
1 期
SAFETY AND IMMUNOGENICITY STUDY of ADL-018 WITH XOLAIR IN HEALTHY ADULT SUBJECTS.CTRI/2022/06/043399Kashiv BioSciences LLC
进行中（未招募）
1 期
A TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN INFANTS BORN TO WOMEN VACCINATED DURING PREGNANCYEUCTR2019-002943-85-FIPfizer Inc., 235 East 42nd Street, New York, NY 1001710,000
进行中（未招募）
1 期
A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated Her2-Positive Metastatic Breast CancerEUCTR2007-002997-72-DEF. Hoffmann-La Roche Ltd.800
进行中（未招募）
1 期
A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated Her2-Positive Metastatic Breast CancerHER2 positive metastatic breast cancerMedDRA version: 20.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2007-002997-72-LVF. Hoffmann-La Roche Ltd.808
已完成
不适用
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF LEBRIKIZUMAB IN PATIENTS WITH UNCONTROLLED ASTHMA WHO ARE ON INHALED CORTICOSTEROIDS AND A SECOND CONTROLLER MEDICATI-J45J45PER-050-13F. HOFFMANN-LA ROCHE LTD.,47