UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033924 |
|---|---|
| Receipt number | R000037594 |
| Scientific Title | Retrospective chart review on natalizumab: Efficacy and safety of long-term treatment with natalizumab in Japanese patients with RRMS |
| Date of disclosure of the study information | 2018/08/28 |
| Last modified on | 2019/04/11 13:07:36 |
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Basic information
Public title
Retrospective chart review on natalizumab: Efficacy and safety of long-term treatment with natalizumab in Japanese patients with RRMS
Acronym
Retrospective chart review on long-term treatment with natalizumab in Japanese patients with RRMS
Scientific Title
Retrospective chart review on natalizumab: Efficacy and safety of long-term treatment with natalizumab in Japanese patients with RRMS
Scientific Title:Acronym
Retrospective chart review on long-term treatment with natalizumab in Japanese patients with RRMS
Region
| Japan |
Condition
Condition
Relapsing-Remitting Multiple Sclerosis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the presence or absence of new active lesions in MRI by assessing new or newly-enlarging T2-hyperintense lesions before and after treatment with natalizumab
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The proportion of subjects with new/newly enlarging T2-hyperintense lesions after treatment (each year up to 5 years)
Key secondary outcomes
The changes after treatment (each year up to 5 years) in the following:
- Proportion of subjects with new Gd-enhancing lesions
- Clinical relapse rate (ARR)
- Expanded disability status scale
- Anti-JCV antibody 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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Relapsing-Remitting Multiple Sclerosis
2. 18 years old or over
3.Treated for at least 1 year with natalizumab (including patients who discontinued after receiving natalizumab for more than 1 year).
4. No treatment gap of more than 12 weeks
Key exclusion criteria
Refusal of consent by opt-out prior to the initiation of the study
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takahiko |
| Middle name | |
| Last name | Saida |
Organization
IRINO MEDICAL CLINIC, LLC
Division name
Neurology
Zip code
556-0016
Address
2-3-19 Motomachi, Naniwa-ku, Osaka, Japan
TEL
090-2287-1021
saida_takahiko@icloud.com
Public contact
Name of contact person
| 1st name | Takahiko |
| Middle name | |
| Last name | Saida |
Organization
IRINO MEDICAL CLINIC, LLC
Division name
Neurology
Zip code
556-0016
Address
2-3-19 Motomachi, Naniwa-ku, Osaka, Japan
TEL
090-2287-1021
Homepage URL
saida_takahiko@icloud.com
Sponsor or person
Institute
IRINO MEDICAL CLINIC, LLC
Institute
Department
Personal name
Funding Source
Organization
Biogen Japan Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical corporation Tokeikai Kitamachi clinic ethics review committee
Address
1-1-3 Kichijoji Kitamachi, Musashino City, Tokyo
Tel
03-6779-8166
shingo-namiki@j-smo.com
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
医療法人入野医院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 28 | 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
85
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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 02 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 05 | Day |
Date analysis concluded
| 2019 | Year | 05 | Month | 31 | Day |
Other
Other related information
Retrospective study using existing medical records ( 1 February, 2010 - 31 January, 2018 ) in participating medical institution.
Management information
Registered date
| 2018 | Year | 08 | Month | 28 | Day |
Last modified on
| 2019 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037594
