EUCTR2011-004475-36-BG进行中（未招募）不适用
A Phase IIa, randomized, double-blind, placebo-controlled, exploratory, dose-ranging study to evaluate the safety, effectiveness and pharmacokinetics of three courses of DC-TAB treatment in patients with multiple sclerosis
Delta Crystallon B.V.0 个研究点开始时间: 2012年4月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Main inclusion criteria:
- •Clinically definite, relapsing multiple sclerosis, according to the McDonald criteria, and abnormal MRI scan consistent with MS
- •Neurologically stable
- •At least one clinical relapse over the previous year, or two relapses over the past two years, or one or more gadolinium-enhancing MRI lesion(s) at the time of screening.
- •An EDSS score smaller than or equal to 5.5
- •Age 18-55 years
- •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 32
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Primary progressive multiple sclerosis
- •2. Use of systemic corticosteroid treatment for more than 3 days within 30 days prior to screening
- •3. Plasmapheresis, or intravenous gammaglobulins less than 2 months before screening
- •4. Treatment with natalizumab less than one year before screening
- •5. Previous immunosuppressive treatment (e.g. cyclophosphamide or mitoxantrone)
- •6. Previous treatment with any leukocyte-targeting monoclonal antibody (e.g. rituximab, alemtuzumab, daclizumab)
- •7. Previous treatment with oral immune-modulatory agents (cladribine, fingolimod, laquinimod, fumarate)
- •8. Pregnant women, women planning to become pregnant and breastfeeding women
- •9. A history of or currently active clinically significant cardiac (including clinically significant ECG abnormalities in the opinion of the PI), pulmonary, gastrointestinal, hepatic, renal, pancreatic, or neurological disease
- •10. ALT, AST and/or gamma-GT above 3 times the upper limit of normal
- •11. Serum creatinine above 1.5 times the upper limit of normal or an eGFR < 60 ml/min/1.73 m2
- •12. Hemoglobin < 7.0 mmol/l for females and < 8 mmol/l for males; leucocytes > 20*109/l or < 3.5*109/l; platelets < 125*109/l
- •13. SBP > 160 mmHg and/or DBP > 100 mmHg
- •14. Acute respiratory or other active infections
- •15. Fever (body temperature > 38.0 °C on day 1
- •16. Blood donation or significant blood loss within 90 days of first study medication dosing
- •17. Plasma donation within 7 days of first study medication dosing
- •18. Recipients of blood or blood products in the last 6 months
- •19. Participation in another clinical study within 90 days of the start of this trial or planning participation in another clinical trial during this study or in the 4 weeks after last visit
- •20. Taking anti-coagulation or anti-platelet medication with the exception of NSAID’s.
- •21. History of drug addiction (positive drug screen) or excessive use of alcohol (weekly intake more than 28 units of alcohol), or psychological or other emotional problems that are likely to invalidate informed consent, or limit the ability of the patient to comply with the protocol requirements
- •22. Vaccination with any vaccine within 4 weeks prior to dosing of the study medication
- •23. History of serious adverse reactions or hypersensitivity to any medicinal product
- •24. History of a malignancy other than skin cell basalioma 5 years prior to screening
- •25. Any physical condition that would, in the opinion of the investigator, place the patient at an unacceptable health risk or risk of injury or render the patient unable to meet the requirements of the protocol
研究者
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