Exploring the effect of a novel therapy on intrathecal inflammation in patients with MS
What was tested
Treatment tested
- Siponimod
Sphingosine 1-phosphate receptor Edg-1 agonist
What it measured
Main measures
To characterize the effect of the drug on cerebrospinal fluid markers of chronic intrathecal inflammation. According to literature, to our previous studies and preliminary data, that pointed to a key role of CXCL13 in mediating B-cell accumulation and its association with disease severity and progression, the sample size has been calculated taking in account as primary endpoint to measure changes
Blood or spinal fluid markersImmune response
Other measures (1)
the characterization of intrathecal (and paired blood) adaptive and immune cell subsets through a high-dimensional flow cytometry performed at T0 and after two years of treatment (T24).; Evaluation of paired blood and CSF markers of inflammation and neurodegeneration at T0 and T24; Assessment of CSF oligoclonal bands status and number at T0 and after two years of treatment (T24).; Assessment of th
Disability progressionMRI lesionsSmouldering inflammationBlood or spinal fluid markersThinking and memoryImmune responseSafety
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History
- In scope changed from true to false
Started
Jan 2023
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