multiple sclerosis
Conditions
Interventions
Singe spinal tap and blood withdrawal for scientific research
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Diagnosis MS according to Poser or any version of the McDonald criteria. • Age >=45 years of age; • Treatment with interferon beta, glatiramer acetate, dimethyl fumarate or teriflunomide; • Absence of relapses within the previous 5 years; • Absence of active MRI lesions (new T2 lesions compared to MRI
Exclusion criteria
Exclusion criteria: • Use of oral anticoagulants OR clopidogrel as platelet aggregation inhibitor; • Any other contra-indication for a lumbar punction; • Unwillingness to undergo a lumbar and/or venous puncture.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Presence of CSF-unique oligoclonal bands (Y/N) • Composite endpoint presence of inflammatory disease activity (all/one item Y = Y; all N=N), consisting of: o New T2 MRI white matter lesions at 1 year follow-up cerebral MRI scan (Y/N) o Gadolinium-enhancing T1 MRI white matter lesions at 1 year follow-up cerebral MRI scan (Y/N) o The presence of a clinically clear exacerbation of disease with new neurological symptoms lasting >24h and not suspect for a pseudo schub | — |
Secondary
| Measure | Time frame |
|---|---|
| • Number of CSF-unique oligoclonal band (N) • Elevated intrathecal IgG production (Y/N) • Cell count (N) • CSF total protein level (concentration) • CSF glucose (concentration) • Number of new T2 MRI lesions at 1 year follow-up cerebral MRI scan (N) • Number of gadolinium-enhancing T1 MRI lesions at 1 year follow-up cerebral MRI scan (N) • Sex (M / F) • Year of birth (Y) • Year of first symptoms (Y) • Year of diagnosis (Y) • Year of walking with stick (Y) • Year of restricted to wheelchair (Y) • Diagnosis (RRMS; SPMS; PPMS; not specified) • Earlier lumbar puncture performed (Y/N) • Year of earlier lumbar puncture (Y) • CSF-unique oligoclonal bands present (Y/N/unknown) • Disease modifying therapies used previously/ currently (descriptive) • Comorbidities (descriptive) • PDDS (step 0-8; Dutch translation attached) • Worsening of walking last 5 years >= 1 point PDDS? • Year of last relapse (Y) • Adverse events (descriptive) • Serious adverse events (descriptive) Tertiary endpoints • Proportions/ phenotypes B/ T cell subsets • CSF levels of neurofilament light chain (NfL)/ soluble CD27 (sCD27)• Exploratory endpoint composite endpoint presence of inflammatory disease activity from 12 months follow-up until the last-patient-last-visit timepoint | — |
Countries
Netherlands
Contacts
Public ContactJ.J.F.M. Smolders
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed