EUCTR2017-001362-25-DK进行中（未招募）1 期
Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS
Helse Bergen HF, Haukeland University Hospital0 个研究点目标入组 100 人开始时间: 2018年3月21日最近更新:
适应症
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
- 100
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. Age between =18 to =50, both genders
- •3. Diagnosis of RRMS using revised McDonald criteria of clinically definite MS
- •4. An EDSS score of 0 to 5.5
- •5. Significant inflammatory disease activity despite treatment with standard disease modifying therapy for at least 6 months, with one or more of the following medications; interferon beta, glatiramer acetate, dimethyl fumarate, teriflunomide, fingolimod, natalizumab
- •a.Significant inflammatory disease activity is defined as:
- •i. Having one or more clinically reported multiple sclerosis (MS) relapse(s),
- •ii. AND 1 or more T1 Gd-enhanced lesion(s),
- •iii. OR three or more new or enlarging T2 lesions on magnetic resonance imaging (MRI) over the last year while being treated with
- •immunomodulatory treatment by standard national guidelines .
- •The relapse(s) must have occurred 3 or more months after the onset of an immunomodulatory treatment, as MS immunomodulatory treatment may reach full effect after 3 months or more.
- •6.The patient is a RRMS-patient referred from neurological departments in Norway, Denmark, Sweden, the Netherlands to an assigned study site.
- •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 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.Known hypersensitivity or other known serious side effects for any of the study medications, including co-medications such as high-dose glucocorticosteroids
- •2.Any illness or prior treatment that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemotherapy or high-dose glucocorticosteroids
- •3.Any ongoing infection, including Tbc, CMV, EBV, HSV, VZV, hepatitis virus, toxoplasmosis, HIV or syphilis infections, as well as heaptitis B surface antigen positivity and/or hepatitis C PCR positivity verified at Visit 1
- •4.Patients without a history of chickenpox or without vaccination against varicella zoster virus (VZV), unless tested for antibodies to VZV. VZV negative patients can only be included if they receive vaccination against VZV at least 6 weeks prior to inclusion.
- •5.Current or previous treatments with long-term effects that may influence the treatment effects or potential toxicities/side effects of the treatment arms. This includes, but is not restricted to previous treatment with mitoxantrone, alemtuzumab, cladribin and ocrelizumab, and treatment with rituximab within the last 9 months prior to start of study treatment.
- •6.Immunocompromised patients, or patients currently reveiving immunosuppressive or myelosuppressive therapy
- •7.Treatment with glucocorticoids or ACTH within one month prior to start of study treatment
- •8.Having experienced an MS relapse within one month prior to study inclusion
- •9.Prior or current major depression
- •10.Prior or current psychiatric illness, mental deficiency or cognitive dysfunction influencing the patient ability to make an informed consent or comply with the treatment and follow-up phases of this protocol.
- •11.Prior or current alcohol or drug dependencies
- •12.Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhytmia, unstable or advanced ischemic heart disease (NYHA III or IV)
- •13.Significant hypertension: BP > 180/110
- •14.Active malignancy, or prior history of malignancy except localized basal cell, squamous skin cancer or carcinoma in situ of the cervix.
- •15.Known untreated or unregulated thyroid disease
- •16.Failure to willingly accept or comprehend risk of irreversible sterility as a side effect of therapy
- •17.WBC < 1,5 x 109/L if not caused by a reversible effect of documented ongoing medication. If WBC < 1,5 x 109/L is caused by a reversible effect of documented ongoing medication the WBC count must be > 1,5 x 109/L before start of study treatment.
- •18.Platelet (thrombocyte) count < 100 x 109/L
- •19.ALAT and/or ASAT more than 2 times the upper normal reference limit (UNL)
- •20.Serum creatinine > 200 µmol/L
- •21.Serum bilirubin > ULN
- •22.Moderate or severely impaired kidney function (creatinine-clearance below 60 ml/min)
- •23.Presence of metallic objects implanted in the body that would preclude the ability of the patient to safely have MRI exams
- •24.Diagnosis of primary progressive MS
- •25.Diagnosis of secondary progressive MS
- •26.Treatment with natalizumab and fingolimod within the last 2 months, and treatment with dimetylfumurat within the last month (washout must be performed as specified in section 5.1) prior to start of study medication.
- •27.Use of teriflunomide (Aubagio®) within the previous 2 years unless cleared from the body (plasma concentration < 0.02 mcg/ml following elimination from the body with cholestyramine or activated powdered charcoal) as specified in section 5.1 prior to start of study medication.
研究者
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