A multicentre, retrospective study in patients with multiple sclerosis treated with natalizumab in real-world setting in Japan

A multicentre, retrospective study in patients with multiple sclerosis treated with natalizumab in real-world setting in Japan - REFIND Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044955

Enrollment

150

Registered

2021-07-26

Start date

2021-07-27

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis (MS)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Patients who are deemed inappropriate for participation in this study by the principal investigator or sub-investigator.

Design outcomes

Primary

Measure	Time frame
1) Dosing pattern of NTZ 2) Annual relapse rate (ARR) by NTZ dosing pattern	—

Secondary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

Japan

Contacts

Public ContactSatoru Enomoto

Mebix, Inc. Research Promotion Group

ntz-eid@mebix.co.jp03-4362-4504

Outcome results