UMIN-CTR Clinical Trial

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
Last 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
Email	saida_takahiko@icloud.com

Public contact
1st 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
Email	saida_takahiko@icloud.com

Sponsor
Institute	IRINO MEDICAL CLINIC, LLC
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037594