EUCTR2016-001166-29-DE进行中（未招募）1 期
A randomised controlled trial to compare ocrelizumab or alemtuzumab with autologous hematopoietic stem cell transplantation (aHSCT) in high inflammatory multiple sclerosis (COAST) - COAST
niversity Medical Centre Hamburg-Eppendorf0 个研究点目标入组 50 人开始时间: 2019年8月12日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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. Written informed consent and agreement to comply to study protocol
- •2. Age: 18-55 years
- •3. EDSS: 0.0 – 6.0
- •4. RRMS according to McDonald 20108
- •5. < 10 years of disease course after symptom onset
- •6. Active disease with one of the following treatment failures occurring not earlier than 6 months after initiation of an approved DMT:
- •- 2 or more relapses within the last 12 months
- •- 1 relapse within the last 12 months and a Gd-enhancing lesion on MRI > 3 mm > 3 months before or after relapse onset or 2 new T2-lesions
- •- On-going signs of MRI activity in the last 6 months (either Gd-enhancing of = 3 mm lesion at any exam in the last year; or more than 5 new T2 lesions (= 3 mm))
- •- Patients stable under natalizumab but who have to stop treatment due to an increasing PML risk are defined as active, if a MRI within 6 months after termination of natalizumab shows new T2 or Gd-enhancing lesions and at least one other treatment failure prior to natalizumab is documented
- •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 50
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Secondary or primary progressive MS
- •2. Pregnancy, or other medical condition incompatible with aHSCT
- •3. Any treatment or medical condition that, according to the haematologist / transplant specialist precludes the use of aHSCT
- •4. John Cunningham virus (JCV) antibody index of > 1.5 in previously natalizumab-treated patients, if a negative CSF JCV-PCR prior to screening is not available
- •5. Relapse during 30 days before initiation of treatment. If a relapse occurs during this period and eligibility criteria are otherwise fulfilled, start of treatment will be delayed until at least 30 days after receiving steroids.
- •6. Concurrent clinically significant (as determined by the investigators and haematologist / transplant specialist) cardiac, immunological, pulmonary, neurological, renal or other major disease such as:
- •- Prominent cardial disease (Left ventricular ejection fraction (LVEF) < 40%, myocardial infarction or ischemia, uncontrolled arrhythmias, pericardial effusions > 1 cm)
- •- Cerebrovascular disease
- •- Renal disease (creatinine clearance < 30 ml/min/m2)
- •- Respiratory disease (DLCO < 40% predicted)
- •- Active bleeding or clotting disease
- •- History of human immunodeficiency virus (HIV) or positive HIV antibody testing
- •- Any uncontrolled acute or chronic infection, including HIV, hepatitis B surface antigen positivity and hepatitis C PCR positivity
- •- Cancer except in situ cervix or cutaneous
- •7. Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the patient returning for follow-up visits on schedule. Unwillingness to use contraception.
- •8. Previous participation in this study, previous treatment with aHSCT or already both comparators
- •9. Ongoing immunotherapy. Treatment with interferon or glatirameracetate will need no wash-out. Treatment pause before ocrelizumab/alemtuzumab or aHSCT will be:
- •- for dimethylfumarate and fingolimod: 8 weeks
- •- for natalizumab: 8 weeks
- •- for ocrelizumab: 12 weeks
- •- for alemtuzumab: 12 months
- •- for teriflunomide: 4 weeks after elimination with cholestyramine
- •- for cladribine: 24 weeks
- •10. Patients with cognitive impairments who are unable to provide written, informed consent prior to any testing under this protocol, including screening and baseline investigations that are not considered part of routine patient care.
研究者
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