Escalating therapy in steroid-refractory relapses of multiple sclerosis – comparison of methylprednisolone to immunoadsorptio

Phase 1

• Conditions: Multiple Sclerosis (MS), acute episode; MedDRA version: 20.0Level: HLTClassification code 10052785Term: Multiple sclerosis acute and progressiveSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2017-000635-13-DE
• Lead Sponsor: niversität Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-22
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified