UMIN-CTR Clinical Trial

Public title

Epidemiological study on Japanese patient with multiple sclerosis

Acronym

Epidemiological study on Japanese patient with multiple sclerosis

Scientific Title

Epidemiological study on Japanese patient with multiple sclerosis

Scientific Title:Acronym

Epidemiological study on Japanese patient with multiple sclerosis

Region

Japan

Condition

Clinically isolated syndrome (CIS), Radiologically isolated syndrome (RIS), multiple sclerosis (MS)

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The primary objective of the study is to characterize disease activity of multiple sclerosis in Japanese patients.

Basic objectives2

Others

Basic objectives -Others

To compare the demographic, disease activity and severity in Japanese MS patients with Caucasian patients.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The annualized relapse rate (ARR) of MS

Key secondary outcomes

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key 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.

Key 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

Target sample size

1000

Name of lead principal investigator

1st name	Noriko
Middle name
Last name	Isobe

Organization

Kyushu University

Division name

Department of Neurology Neurological Institute, Graduate School of Medicine

Zip code

812-8582

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka city, Fukuoka Pref., 812-8582, Japan

TEL

092-642-5340

Email

shinkein@neuro.med.kyushu-u.ac.jp

Name of contact person

1st name	Noriko
Middle name
Last name	Isobe

Organization

Kyushu University

Division name

Department of Neurology Neurological Institute, Graduate School of Medicine

Zip code

812-8582

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka city, Fukuoka Pref., 812-8582, Japan

TEL

092-642-5340

Homepage URL

Email

shinkein@neuro.med.kyushu-u.ac.jp

Institute

Kyushu University

Institute

Department

Personal name

Organization

Biogen Japan Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kyushu University Institutional Review Board for Clinical Research

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582, Japan

Tel

092-642-5774

Email

ijkseimei@jimu.kyushu-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2019

Year

10

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2019

Year

06

Month

21

Day

Date of IRB

2019

Year

09

Month

13

Day

Anticipated trial start date

2020

Year

12

Month

14

Day

Last follow-up date

2023

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

After obtaining written informed consent form from each MS patients, information from medical records is anonymized and entered. The medical records, including patients' demographics, disease background such as onset and treatment history of MS, relapse of MS, EDSS and so on are collected retrospectively.
1. If the investigators are "MSBase member", the participants of MSBase Registry study, the medical records of Japanese patients will be entered in MSBase data-entry system (e.g. MDS) and then uploaded as pseudonymized data to the MSBase database. The communication between MDS and MSBase registry use end-end encryption.
2. If the investigators are "non-MSBase member", the medical records of Japanese patients will be pseudonymized and entered into other data-entry system (e.g. iMED). Since the data of "non-MSBase member" are not uploaded to the MSBase registry, the data are not used for the comparison with Caucasians.
3. Based on the background information and the medical records of each Japanese patient registered in MSBase database, propensity score matching (PSM) will be carried out to select the comparative Caucasian subjects from the cohort that has been already registered in MSBase database. The detail method of PSM will be described in statistical analysis plan (SAP).
4. In this study, the patients' information before pseudonymization can be available and can be edited only by each research institution. The pseudonymized data will be accessible to Kyushu University, MSBase foundation and Biogen. The information of each patient is pseudonymized when the results of this study is made public at a relevant academic society or in a publication.

Registered date

2019

Year

09

Month

19

Day

Last modified on

2023

Year

11

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043385