Clinically isolated syndrome (CIS), Radiologically isolated syndrome (RIS), multiple sclerosis (MS)
Conditions
Interventions
None listed
Sponsors
Kyushu University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, candidates must meet the following eligibility criteria. 1. Patients with the first clinically isolated syndrome (CIS) which is caused by inflammatory demyelinating legion at one or more regions in nerve and which continues for 24 hours or longer, patients with radiologically isolated syndrome (RIS), which is asymptomatic but defined by MRI image specific for MS, patients with relapsing-remitting MS (RRMS), patients with primary progressive MS (PPMS), or patients with secondary progressive MS (SPMS). 2. Patients of all age 3. Both male and female 4. Japanese 5. Patients who have provided written consent to participate in this study. However, for patients aged 18 years or older who have difficulty providing written informed consent by themselves, the legally acceptable representatives must provide consent written by themselves after receiving an explanation. For patients under 18 years old, the legally acceptable representatives of the patients should provide written consent after receiving an explanation. For patients who are judged to be able to express their own will to participate in this study, efforts will be made to obtain informed assent.
Exclusion criteria
Exclusion criteria: Candidates will be excluded from study if any of the following exclusion criteria exist. 1. patients who are unsuitable to participate in this study by attending physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The annualized relapse rate (ARR) of MS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients who relapsed 2. Proportion of patients with relapses requiring IV steroid use 3. Mean MS Severity Score (MSSS) 4. Annualized EDSS progression 5. Time to reaching EDSS 3.0, 4.0 and 6.0 from disease onset 6. Time to progress to SPMS 7. Mean number of Gd+ lesions 8. Proportion of patients who had Gd+ lesions 9. Mean number of new and newly enlarged T2 hyperintense lesions 10. Proportion of patients with IgG oligoclonal band positive 11. Categorized anti-JCV antibody index (negative, =<0.9, >0.9 to =<1.5, >1.5) 12. Assessment of prognostic models to address differences regarding ethnicity (Japanese vs. Caucasian) for MS disease activity and severity 13. Subgroup analyses: e.g., age, gender, EDSS, prior treatment, type of MS, region of patient's residence in Japan | — |
Countries
Japan
Contacts
Public ContactNoriko Isobe
Kyushu University Department of Neurology Neurological Institute, Graduate School of Medicine
Outcome results
None listed