臨床研究等提出・公開システム

Date of registration	July. 02, 2019
Last modified on	April. 07, 2022
Trial ID	jRCT1080224761

Scientific Title	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)
Public Title	Investigation for immune response against JC virus in Multiple Sclerosis patients on treatment with fingolimod

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Novartis Pharma K. K.
	Address
	Phone Number	+81-120-003-293
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Novartis Pharma K. K.
	Address
	Phone Number	+81-120-003-293
	E-mail Address

Recruitment Status	completed

Date of First Enrolment		July. 31, 2019
Target Sample Size		280
Study Type		Observational
Study Design	Study Design	A 18-month, multicenter, two-cohort, prospective, observational study
Study Design	Objective	diagnostic purpose
Phase		N/A
Key inclusion & exclusion 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	- 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.
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Multiple Sclerosis
Intervention(s)		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 Administration for Investigational material : 0.5mg/day Fingolimod orally control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		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 Outcome		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

Primary Sponsor	Novartis Pharma K.K.
Secondary Sponsor	Mitsubishi Tanabe Pharma Corporation

Name of Funding Organization	-
Name of Research Funding	-

Name	Kyushu University Ethic Committee for Clinical Research
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka 812-8582
Phone Number
E-mail Address
Status of Review	Approval
Date of Approval	May. 27, 2019

Secondary ID No.	JapicCTI-194838
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
4	April. 07, 2022	(this page)	Changes
3	Mar. 25, 2021	Detail	Changes
2	Aug. 22, 2019	Detail	Changes
1	July. 02, 2019	Detail

List of change history