UMIN-CTR Clinical Trial

Public title

The efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosis

Acronym

Treatment with an anti-interleukin-6 receptor antibody for relapsing-remitting multiple sclerosis

Scientific Title

The efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosis

Scientific Title:Acronym

Treatment with an anti-interleukin-6 receptor antibody for relapsing-remitting multiple sclerosis

Region

Japan

Condition

Relapsing-remitting multiple sclerosis

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to evaluate the efficacy and safety of anti-IL-6R antibody tocilizumab in relapsing-remitting multiple sclerosis with a high plasmablast frequency in peripheral blood and to explore its mechanism of action.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

-Relapse rate, disability (EDSS), and MRI parameters up to 1 or 2 years.
-Adverse events up to 1 or 2 years.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 2 years.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

65

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Diagnosis as relapsing-remitting multiple sclerosis (RRMS) according to 2010 revised McDonald criteria (Ann Neurol 2011; 69: 292-302).

2. Intractable patients with RRMS resistant to standard therapies other than tocilizumab with more than two relapses or disability progression during the 1 year prior to initiation to this study.

3. With a higher plasmablast frequency in peripheral blood than the mean frequency + 2SD in healthy donors by flow cytometry.

4. Provision of written informed consent to participate in this study.

5. Since a relapsing-remitting phase could turn out to be a secondary-progressive phase after the entry, the patients with secondary-progressive MS (SPMS) could be included in this study.

Key exclusion criteria

1) Patients with severe infection such as tuberculosis, pneumocystis carinii pneumonia, nontuberculous mycobacterial infection, hepatitis B, hepatitis C, or chronic active EB virus infection.
2) Patients with a history of tuberculosis infection or patients with pleural thickness or old tuberculin in chest X-ray.
3) Patients with a history of hypersensitivity to this drug.
4) Patients with a history of intestinal diverticulum.
5) Patients with interstitial pneumonitis.
6) Patients with leukopenia (white blood cell number < 3500/mm3), lymphopenia (lymphocyte number < 500/mm3) or seropositivity for beta-D-glucan in peripheral blood.
7) Pregnant women or patients with possible pregnancy.
8) Patients with a history of allergy to this drug
9) Patients who can not provide consent to participate in this study by themselves.

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Takashi Yamamura

Organization

National Institute of Neuroscience, NCNP

Division name

Department of Immunology

Zip code

Address

4-1-1, Ogawahigashi, Kodaira, Tokyo 187-8502, Japan

TEL

042-341-2711

Email

yamamura@ncnp.go.jp

Name of contact person

1st name
Middle name
Last name	Takashi Yamamura

Organization

National Institute of Neuroscience, NCNP

Division name

Department of Immunology

Zip code

Address

4-1-1, Ogawahigashi, Kodaira, Tokyo 187-8502, Japan

TEL

042-341-2711

Homepage URL

Email

yamamura@ncnp.go.jp

Institute

Department of Immunology, National Institute of Neuroscience, NCNP

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

01

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2013

Year

11

Month

14

Day

Date of IRB

Anticipated trial start date

2014

Year

01

Month

07

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

12

Month

26

Day

Last modified on

2016

Year

06

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014841