EUCTR2005-001340-22-FI进行中（未招募）不适用
BHT-3009 IMMUNOTHERAPY IN RELAPSING REMITTING MULTIPLE SCLEROSIS
Bayhill Therapeutics0 个研究点目标入组 252 人开始时间: 2005年7月22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
- 入组人数
- 252
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. Definite diagnosis of multiple sclerosis by the McDonald criteria.
- •2. Screening cranial MRI demonstrating lesions consistent with MS.
- •3. One or more relapses within the previous year.
- •4. Clinically stable (no relapses) for > or = 50 days before beginning screening procedures and during the screening period.
- •5. EDSS 0 to 3,5 inclusive
- •6. Age > or = 18 years and < or = 55 years
- •7. Willing and able to give informed consent.
- •8. WBC>3,000; platelets > 100,000; hemoglobin > or = 10.0 g/dl.
- •9. AST, ALT, bilirubin < or = 2.0 x upper limit of normal.
- •10. Creatinine < or = 2.0 x upper limit of normal.
- •11. Negative test for HIV.
- •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. Primary progressive, secondary progressive or progressive relapsing MS.
- •2. More than 15 gadolinium-enhancing lesions on the first screening MRI.
- •3. High-dose corticosteroids (e.g. > 500 mg methylprednisolone or equivalent per day for 3 or more days) within 50 days prior to beginning screening procedures.
- •4. Previous stem cell transplantation, total lymphoid radiation, or cytotoxic therapy.
- •5. Treatment with interferon, glatiramer acetate or other approved disease-modifying agent for > 180 days (lifetime total of all agents).
- •6. Treatment with an approved disease modifying agent within 180 days of beginning screening procedures.
- •7. Previous treatment of MS with an experimental agent including off-label use of approved drugs. (Allowed with approval of the Medical Monitor.)
- •8. Prior therapy with natalizumab (Tysabri).
- •9. Pregnant or lactating women.
- •10. Unwilling to use a medically acceptable form of birth control (e.g. hormonal contraception, intrauterine device, double barriers, sterilization of self or partner).
- •11. Clinically significant ECG abnormalities (e.g. acute ischemia or life-threatening arrhythmia).
- •12. Medical condition or social circumstances that would in the opinion of the investigator prevent full participation in the trial or evaluation of study endpoints.
- •13. Implanted pace makers, defibrillators or other metallic objects on or inside the body that limit performing MRI scans.
- •14. Known hypersensitivity or allergy to gadolinium.
研究者
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