Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Annual relapse rate (ARR) between baseline and follow-up in patients with IDD |
a new neurological worsening lasting for at least 24 hours and occurring more than 30 days after the previous attack. |
baseline up to 5 years |
|
Primary |
Change in EDSS scores of patients with IDD between baseline and follow-up over time |
The Expanded Disability Status Scale (EDSS) is a rating system that is frequently used for classifying and standardizing the severity and progression. EDSS ranges from 0 to 10. The higher the score, the worse the clinical symptoms. |
baseline, Month 6, Month12, Month18, Month24, Month30, Month36, Month42, Month48, Month54, Month60 |
|
Secondary |
The brain structural change over time between the baseline MRI and the follow-up MRIs |
To describe changes of lesions, grey matter and white matter in patients with neuroinflammatory and demyelination disease measured by Brain Magnetic Resonance Imaging (MRI). The MRI sequence includes T2W_TRA?DWI?3DT1W_TFE_SAG?fMRI_EPI_TRA?mb2DKI_iso48_b1k2k_TRA?3DFLAIR_TSE_SAG?3DpCASL_GRASE_TRA?3DDIR_SAG?3DT2W_TSE?SWI_QSM_TRA. The secondary endpoint is the change over time between the baseline MRI and the follow-up MRIs, of the lesions and brain volumes. |
baseline, year1, year2, year3, year4, year5. |
|
Secondary |
The spinal cord change over time between the baseline MRI and the follow-up MRIs. |
To describe changes of lesions and integrity of fiber bundle in spinal cord in neuroinflammatory and demyelination disease patients measured by MRI. The primary endpoint is the change over time between the baseline MRI and the follow-up MRIs, of structural change in spinal cord. |
baseline, year1, year2, year3, year4, year5. |
|
Secondary |
Change of the central vein sign at 7T MRI. |
The central vein sign has been proposed as a specific imaging biomarker for distinguishing between multiple sclerosis (MS) and not MS. |
baseline, year1, year2, year3, year4, year5. |
|
Secondary |
Change of rim of iron at 7T MRI. |
multiple sclerosis white matter lesions surrounded by a rim of iron containing microglia, termed iron rim lesions, signify patients with more severe disease course and a propensity to develop progressive multiple sclerosis. |
baseline, year1, year2, year3, year4, year5. |
|
Secondary |
Change in High-contrast Letter Acuity (HCLA) over time at baseline and during follow-up in patients with IDD |
Adjusted mean change in HCLA every year from baseline as determined by 100% high contrast Sloan letter charts, adjusted for the baseline HCLA value. |
baseline, year1, year2, year3, year4, year5. |
|
Secondary |
Change in Low-contrast Letter Acuity (LCLA) over time at baseline and during follow-up in patients with IDD |
Adjusted mean change in LCLA at baseline and every year as determined by 2.5% low contrast Sloan letter charts,adjusted for the baseline LCLA value. |
baseline, year1, year2, year3, year4, year5. |
|
Secondary |
Percentage Change in Spectral-domain Optical Coherence Tomography (SD-OCT) Average Retinal Nerve Fiber Layer (RNFL) Thickness at baseline and every year. |
Adjusted mean percentage change in thickness of the RNFL every year for the affected eye from the baseline as determined by SD-OCT. |
baseline, year1, year2, year3, year4, year5. |
|
Secondary |
Percentage change in SD-OCT Average Retinal Ganglion Cell Layer/Inner Plexiform Retinal Layer (RGCL/IPL) every year. |
Adjusted mean change in thicknesses of the RGCL/IPL every year for the affected eye from the baseline as determined by segmentation of SD-OCT. |
baseline, year1, year2, year3, year4, year5. |
|
Secondary |
Changes in cognitive function of patients with IDD at baseline and over time during follow-up |
Scale assessment mainly rely on SDMT(Symbol Digit Modalities Test), MoCA( Montreal Cognitive Assessment), MMSE(Mini-mental State Examination) and so on. The Symbol Digit Modalities Test (SDMT) is widely used because it is easy to administer, reliable and also evaluates information processing speed. The Montreal Cognitive Assessment (MoCA) is a brief, 30-question test that helps healthcare professionals detect cognitive impairments very early on, allowing for faster diagnosis and patient care. The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. |
baseline, year1, year2, year3, year4, year5. |
|
Secondary |
Number of Participants with Adverse Events as a Measure of Safety and Tolerability |
Treatment-emergent adverse events, treatment-emergent serious adverse events (TESAEs), including laboratory measurements as well as their changes or shift from baseline over time |
From baseline to 5 years |
|
Secondary |
NF-L level in serum. |
Neurofilament light (NF-L) is a 68 kDa cytoskeletal intermediate filament protein that is expressed in neurons. Elevated blood concentrations of neurofilament light chain (NfL) were found to correlate with an increase in the number of relapses, disability worsening, MRI disease activity, and brain volume loss in MS. |
baseline, year1, year2, year3, year4, year5. |
|
Secondary |
Determination of serum autoimmune antibodies |
Compare serum AQP4(Aquaporin 4)-ab titers, MOG(Myelin Oligodendrocyte Glycoprotein)-ab titers, MBP(myelin basic protein)-ab titers at baseline and every year. |
baseline, year1, year2, year3, year4, year5. |
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