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

Email

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


Email

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037594


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name