NL-OMON52451招募中3 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 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Diagnosis of RRMS using revised McDonald criteria of clinically definite MS
- •2. Age between > 18 to <50, both genders
- •3. An EDSS score of 0 to 5.5
- •4. Significant inflammatory disease activity in the last year despite treatment
- •with standard disease modifying
- •therapy (interferon beta, glatiramer acetate, dimethyl fumarate, teriflunomide,
- •fingolimod, natalizumab)
- •a. Significant inflammatory disease activity is defined by:
- •ii. AND 1 or more T1 Gd-enhanced lesion(s),
- •iii. OR three or more new or enlarging T2 lesions on magnetic resonance imaging
- •The relapse(s) must have occurred 3 or more months after the onset of an
- •immunomodulatory treatment
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. Treatment with glucocorticoids or ACTH within one month prior to start of
- •study treatment
- •7. Having experienced an MS relapse within one month prior to study inclusion
- •8. Prior or current major depression
- •9. 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.
- •10. Prior or current alcohol or drug dependencies
- •11. Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhytmia,
- •unstable or advanced ischemic heart disease (NYHA III or IV)
- •12. Significant hypertension: BP > 180/110
- •13. Active malignancy, or prior history of malignancy except localized basal
- •cell, squamous skin cancer or carcinoma in situ of the cervix.
- •14. Known untreated or unregulated thyroid disease
- •15. Failure to willingly accept or comprehend risk of irreversible sterility as
- •a side effect of therapy
- •16. 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.
- •17. Platelet (thrombocyte) count < 100 x 109/L
- •18. ALAT and/or ASAT more than 2 times the upper normal reference limit (UNL)
- •19. Serum creatinine > 200 µmol/L
- •20. Serum bilirubin > ULN
- •21. Presence of metallic objects implanted in the body that would preclude the
- •ability of the patient to safely have MRI exams
- •22. Diagnosis of primary progressive MS
- •23. Diagnosis of secondary progressive MS
- •24. 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.
- •25. Use of teriflunomide (Aubagio®) within the previous 2 years unless cleared
- 另有 4 项未显示
研究者
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