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Table 1 In- and exclusion criteria of the INCIDENT-MS study

From: Immunoadsorption versus double-dose methylprednisolone in refractory multiple sclerosis relapses

Inclusion criteria

• Signed informed consent form

• Established diagnosis of relapsing MS according to the 2017 revised McDonald-criteria

• Incomplete remission of symptoms after administration of 1000 mg intravenous (methyl-) prednisolone as measured by the EDSS value:

•EDSS value baseline + 1, if pre-treatment EDSS value is ≤ 3.5; EDSS value baseline + 0.5, if pre-treatment EDSS value is > 3.5

• Absence of clinically apparent fever or concomitant infection. Asymptomatic urinary tract infection is not considered as significant infection unless it leads to an at least two-fold increase of C-reactive protein levels above ULN (upper level of normal)

Exclusion criteria

• Patients with a documented EDSS > 6.5 prior to recent relapse. Patients that are suspicious to having entered a secondary-progressive course of the disease at the time point of screening

• Patients that previously received either escalation treatment for refractory MS relapses

• Female patients known to be pregnant or unwilling to perform a pregnancy test

• Patients that receive immunosuppressive treatment for diseases other than RRMS or that receive long-term corticosteroid treatment

• Patients that received less than 3 g or more than 5 g (methyl-)prednisolone prior to initial admission or that received (methyl-)prednisolone for more than 8 days

• Patients with verified infection by human-immunodeficiency-virus or hepatitis-c-virus

• Patients with medical, psychiatric, cognitive, or other conditions that, in the investigator’s opinion, compromise the patient's ability to understand the patient information, to give informed consent, or to complete the study

• Patients with significant psychiatric comorbidities with the necessity of specific treatment during administration of intravenous steroids at the investigators discretion

• Patients on regular medication with inhibitors of angiotensin-converting-enzyme (ACE) inhibitors

• Patients with major impairment of the blood coagulation system with increased risk during establishment of central venous catheters as follows:

•therapy with anticoagulants for any purpose other than prevention of deep vein thrombosis

•elevation of INR above 1.5, elevation of PTT above 50 s

•thrombocytopenia below 50.000/μL

•intake of dual antiplatelet therapy

  1. MS multiple sclerosis, NMOSD neuromyelitis optica-spectrum disorder, CRION chronic-relapsing inflammatory optic neuropathy, EDSS expanded disability status scale, ON optic neuritis, ULN upper limit of normal, ACE angiotensin converting enzyme, INR international normalized ratio, PTT partial thromboplastin time