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Retrospective chart review on natalizumab: Efficacy and safety of long-term treatment with natalizumab in Japanese patients with RRMS

Retrospective chart review on natalizumab: Efficacy and safety of long-term treatment with natalizumab in Japanese patients with RRMS - Retrospective chart review on long-term treatment with natalizumab in Japanese patients with RRMS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000033924
Enrollment
80
Registered
2018-08-28
Start date
2018-08-28
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

Relapsing-Remitting Multiple Sclerosis

Interventions

None listed

Sponsors

IRINO MEDICAL CLINIC, LLC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Refusal of consent by opt-out prior to the initiation of the study

Design outcomes

Primary

MeasureTime frame
The proportion of subjects with new/newly enlarging T2-hyperintense lesions after treatment (each year up to 5 years)

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactTakahiko Saida

IRINO MEDICAL CLINIC, LLC Neurology

saida_takahiko@icloud.com090-2287-1021

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026