EUCTR2017-000635-13-DE进行中（未招募）1 期
Escalating therapy in steroid-refractory relapses of multiple sclerosis – comparison of methylprednisolone to immunoadsorption
niversität Leipzig0 个研究点目标入组 140 人开始时间: 2018年2月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
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.= 18 years
- •2.Diagnosis of MS (according to McDonald criteria, revision of 2017) or of clinically isolated syndrome of CNS demyelination
- •3.Acute relapse (new or recurring symptoms lasting at least 24 hrs, affecting the subject’s activities of daily living [ADL])
- •4.Initial therapy of current relapse with IVMP (2500 - 5000 mg total dose) with unsatisfactory response
- •5.EDSS at screening 2.0-8.0
- •6.At screening, interval since onset of current relapse maximum 28 days
- •7.At screening, interval since end of initial course of IVMP** at least 7 days
- •8.Before onset of qualifying MS relapse, clinically stable for at least 30 days
- •9.Written informed consent
- •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 140
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Primary (PPMS) or secondary progressive MS (SPMS)
- •2.Pseudo-relapse associated with fever or infection. Assessment of a potential pseudo-relaose will be performed at screening and include a) history, b) clinical findings on physical examination, c) vital signs and d) laboratory results.
- •3.Known chronic autoimmune disorder (except for autoimmune thyroidits with hypothyroidism under sufficient substitution treatment) or deteriorating neurological condition except for MS
- •4.Known malignant disease within 5 years of screening (except for localized basal cell carcinoma)
- •5.Current or past relevant psychiatric disease (dementia, dissociative disorder, psychotic features, schizophrenia)
- •6.Current depression (if BDI > 17 pts., thorough clinical evaluation is necessary to determine if MP therapy is feasible)
- •7.Known allergies against methylprednisolone, a component of the MP product to be used locally; or against any components of immunoadsorption columns potentially used at the study site (i.e. camelid immunoglobulins or agarose if TheraSorb® may be used; protein A/ Peptid GAM if Immunosorba/Globaffin® may be used)
- •8.Side-effects from MP during the initial treatment course that would, if recurring, foreseeably lead to MP discontinuation
- •9.Contraindications to the use of methylprednisolone:
- •Insufficiently controlled diabetes
- •Insufficiently controlled arterial hypertension;
- •active infection with elevated inflammation parameters (e.g. hemogram, CrP);
- •tuberculosis (According to the Fachinformation (SmPC) for methylprednisolone, tuberculosis should be ruled out before any administration of i.v. methylprednisolone; unless a chest X-ray was performed and found unremarkable within the past year, a chest X-ray is recommended. Such chest X-ray constitutes part of clinical routine and is not a study procedure. )
- •vaccination with a live vaccine within 2 weeks before randomization;
- •severe osteoporosis / osteopenia;
- •10.Contraindications to the use of IA:
- •Current use of ACE-inhibitors or sartans (taken within 3 d prior to visit 3/beginning of treatment), which can neither be replaced nor paused
- •Known disorders of the hemostatic system of vascular (e.g. von Willebrand syndrome), coagulation (e.g. hemophilia) or cellular (e.g. thrombocytopenia) origin
- •Conditions that prohibit anticoagulation using heparin and/or citrate
- •11.Abnormal results of coagulation tests, or thrombocytopenia at Screening acc. to local laboratory reference values
- •12.Known active infection with hepatitis B, C or HIV
- •13.Any condition which is, at the time of screening and foreseeably for the remaining study period, severely compromising immune function (e.g. AIDS, severe systemic infection)
- •14.Current drug abuse
- •15.Pregnant or breast feeding women
- •16.Women of child bearing potential without highly effective contraceptive measures (Clinical Trial Facilitation Group (CTFG) 9/15/2014) during the interval between screening and day 45.
- •17.Anticipated poor compliance (e.g. due to long travel distance to the trial site)
- •18.Current participation in other interventional clinical trial
- •19.Patients under legal supervision or guardianship.
- •20.Patients placed in an institution by official or court order
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