UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044955 |
|---|---|
| Receipt number | R000051357 |
| Scientific Title | A multicentre, retrospective study in patients with multiple sclerosis treated with natalizumab in real-world setting in Japan |
| Date of disclosure of the study information | 2021/07/26 |
| Last modified on | 2022/08/22 15:31:43 |
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Basic information
Public title
A multicentre, retrospective study in patients with multiple sclerosis treated with natalizumab in real-world setting in Japan
Acronym
REFIND Study
Scientific Title
A multicentre, retrospective study in patients with multiple sclerosis treated with natalizumab in real-world setting in Japan
Scientific Title:Acronym
REFIND Study
Region
| Japan |
Condition
Condition
Multiple sclerosis (MS)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the actual treatment status and the disease activity in MS patients treated with natalizumab (NTZ) for over 1 year in the real-world clinical practice in Japan.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Dosing pattern of NTZ
2) Annual relapse rate (ARR) by NTZ dosing pattern
Key secondary outcomes
1) The following effectiveness end points will be evaluated by NTZ dosing patterns and in overall patients
- Cumulative incidence of relapse
- Time to first relapse after initial NTZ treatment
- Proportions of patients with and without relapse
- Disability progression as determined by EDSS: disability progression over time, EDSS change from baseline, and proportions of patients with disease progression and improvement
- Number of new or enlarged T2/FLAIR, and Gd+ lesions using MRI
2) No evidence disease activity (NEDA-3)
3) Comparison of ARR before and after NTZ treatment in overall patients
4) Comparison of ARR during SID and after switching to EID in patients with SID/EID
5) Comparison of ARR during SID and after switching to EID in patients with SID/EID who received initial NTZ treatment after January 2018
6) Information on NTZ discontinuation (number of patients, treatment pattern before discontinuation, duration of treatment, and reason for discontinuation)
7) Anti-JCV antibody (percentage of anti-JCV-positive and -negative patients, seroconversion rate, and change in JCV index)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients aged >=20 years
2) Patients with a diagnosis of MS (Diagnosis according to McDonald 2017 diagnostic criteria)
3) Patients who received at least one dose of NTZ after January 1, 2018
4) Patients with one or more clinical data after starting NTZ treatment
5) Patients who have given written informed consent to collect the data in this study
Key exclusion criteria
Patients who are deemed inappropriate for participation in this study by the principal investigator or sub-investigator.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Ichiro |
| Middle name | |
| Last name | Nakashima |
Organization
Tohoku Medical and Pharmaceutical University
Division name
Department of Neurology
Zip code
983-8536
Address
1-12-1 Fukumuro, Miyaginoku, Sendai-shi, Miyagi, Japan
TEL
022-290-8850
nakashima@tohoku-mpu.ac.jp
Public contact
Name of contact person
| 1st name | Satoru |
| Middle name | |
| Last name | Enomoto |
Organization
Mebix, Inc.
Division name
Research Promotion Group
Zip code
105-0001
Address
Toranomon 33 Mori Building, 3-8-21 Toranomon, Minato-ku, Tokyo, Japan
TEL
03-4362-4504
Homepage URL
ntz-eid@mebix.co.jp
Sponsor or person
Institute
Tohoku Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Biogen Japan Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Independent Ethics Committee of Tohoku Medical and Pharmaceutical University Hospital
Address
1-12-1 Fukumuro, Miyaginoku, Sendai-shi, Miyagi, Japan
Tel
022-259-1221
tikenn@hosp.tohoku-mpu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observational study, and the information necessary for the evaluation will be collected from the medical records of patients.
Management information
Registered date
| 2021 | Year | 07 | Month | 26 | Day |
Last modified on
| 2022 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051357
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
