UMIN-CTR Clinical Trial

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
Email	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
Email	ntz-eid@mebix.co.jp

Sponsor
Institute	Tohoku Medical and Pharmaceutical University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051357