臨床研究等提出・公開システム

Date of registration	Sept. 14, 2017
Last modified on	April. 22, 2021
Trial ID	jRCT2080223655

Scientific Title	A 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab
Public Title	Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab

Completion Date or Terminated date	Sept. 30, 2020
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

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		Mar. 15, 2018
Target Sample Size		30
Study Type		Interventional
Study Design	Study Design	Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion criteria	Inclusion Criteria	* Diagnosis of multiple sclerosis (MS) * Relapsing MS * At least 1 appearance of a new neurological abnormality or worsening of pre-existing neurological abnormality during the previous 2 years prior to Screening AND an MRI activity (Gd-enhanced T1 lesions or new or enlarging T2 lesions) in brain during the previous 1 year prior to randomization * EDSS score of 0 to 5.5
	Exclusion Criteria	* Primary progressive MS or SPMS without disease activity Patients with an active chronic disease of the immune system other than MS Patients at risk of developing or having reactivation of hepatitis * Patients with active systemic infections or with neurological findings consistent with PML Other protocol defined inclusion/exclusion criteria may apply.
	Minimum Age	18age old over
	Maximum Age	55age old under
	Gender	Both
Health Condition or Problem Studied		Relapsing Multiple Sclerosis
Intervention(s)		investigational material(s) Generic name etc : Ofatumumab INN of investigational material : - Therapeutic category code : 399 Agents affecting metabolism, n.e.c. Dosage and Administration for Investigational material : Ofatumumab 20 mg subcutaneous injections every 4 weeks control material(s) Generic name etc : Placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : Placebo subcutaneous injection matching to ofatumumab every 4 weeks
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy Mean number of gadolinium enhanced T1 lesions across 4 MRI scans (ofatumumab vs placebo) [ Time Frame: Week 12, 16, 20 and 24 ] The number of gadolinium enhanced T1 lesions on MRI scans will be measured by the central MRI reading center.
Secondary Outcome		efficacy Mean number of gadolinium enhanced T1 lesions across 4 MRI scans (Japan vs other countries) [ Time Frame: Week 12, 16, 20 and 24, 36, 48 and end of study up to Week 72 ] The number of gadolinium enhanced T1 lesions on MRI scans will be measured by the central MRI reading center. efficacy Number of new or enlarging T2 lesions on MRI scans compared to baseline [ Time Frame: Baseline, Week 12, 16, 20 and 24, 36, 48 and end of study up to Week 72 ] The number of new or enlarging T2 lesions on MRI scans compared to baseline will be measured by the central MRI reading center. efficacy Annualized relapse rate [ Time Frame: Week 24, 48 and end of study up to Week 72 ] Annualized relapse rate is the number of confirmed relapses in a year calculated based on cumulative number of relapses. efficacy B-cell count [ Time Frame: Baseline, Day 2, 5, 7, 14, Week 4, 12, 24, 28, 36, 48, 60 and 72 ] Blood samples will be collected at the scheduled visit. The CD19+ B-cell count will be measured by the central laboratory. efficacy Time to first relapse [ Time Frame: Week 24, 48 and end of study up to Week 72 ] Time to first relapse is the period until the first relapse is confirmed from the first study drug injection.

Primary Sponsor	Novartis Pharma K.K.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Keio University Hospital IRB
Address of IRB	35, Shinanomachi, Shinjuku-ku, Tokyo
Phone Number of IRB	+81-3-5363-3961
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Dec. 04, 2017

Secondary ID No.	NCT03249714
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-173711
Name of Other Registries

Countries / Regions of Recruitment	Japan/Russia

History of Changes

No	Publication date
9	April. 22, 2021	(this page)	Changes
8	Mar. 26, 2021	Detail	Changes
7	Aug. 18, 2020	Detail	Changes
6	Aug. 19, 2019	Detail	Changes
5	Dec. 17, 2018	Detail	Changes
4	April. 09, 2018	Detail	Changes
3	April. 09, 2018	Detail	Changes
2	Sept. 14, 2017	Detail	Changes
1	Sept. 14, 2017	Detail

List of change history