Investigation for immune response against JC virus in Multiple Sclerosis patients on treatment with fingolimod

A 18-month, multicenter, two-cohort, prospective, observational study to investigate immune response against JC virus in Multiple Sclerosis patients on treatment with 0.5 mg fingolimod (FTY720)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080224761

Enrollment

280

Registered

2019-07-02

Start date

2019-07-31

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

Interventions

investigational material(s) Generic name etc : Gilenya / Imusera INN of investigational material : Fingolimod Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients already on commercially prescribed fingolimod treatment (0.5 mg/day orally) for >= 2 years and are suitable to continue fingolimod treatment, or patients who will start commercially prescribed fingolimod treatment (0.5 mg/day orally) as per investigator's discretion (former in the main Cohort 1, latter in Cohort 2). - Patients who are neurological stable (no clinical relapse) at least 1 month before entering the study. - Patients who are expected to follow visit schedule for at least once a year. - Patients willing and able to provide written informed consent.

Exclusion criteria

Exclusion criteria: - Simultaneous participation in a study that includes administration of any investigational drug or procedure. - Patients contraindicated for fingolimod treatment as per the Japanese package insert. - Patients with known hypersensitivity to any component of fingolimod. - Patients with serious infections. - Patients being treated with a class Ia (quinidine, procainamide, etc.) or class III (amiodarone, sotalol, etc.) anti-arrhythmic drug. - Pregnant or possibly pregnant women. - Patients who is aquaporin 4-antibody positive or diagnosed as neuromyelitis optica (NMO) or NMO spectrum disorders according to the International Panel for NMO Diagnosis in 2015.

Design outcomes

Primary

Measure	Time frame
other - Seroconversion rate of anti-JCV antibody (change in positive rate) - Change from baseline in anti-JCV antibody index over different time points of routine clinicalpractice	—

Secondary

Measure	Time frame
other - Seroconversion rate of anti-JCV antibody in a Japanese Cohort 1 compared with FLUENT study Cohort 2 - Change from baseline in anti-JCV antibody index values in a Japanese Cohort 1 compared with FLUENT study Cohort 2	—

Countries

Japan

Outcome results

None listed

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