UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000041047
Receipt number	R000046874
Scientific Title	General Drug Use Surveillance (All Patient Surveillance) of ENSPRYNG Syringes for Subcutaneous Injection - Prevention of relapses of neuromyelitis optica spectrum disorder (including neuromyelitis optica) -
Date of disclosure of the study information	2020/08/26
Last modified on	2022/12/28 06:54:12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information

Public title

General Drug Use Surveillance (All Patient Surveillance) of ENSPRYNG Syringes for Subcutaneous Injection
- Prevention of relapses of neuromyelitis optica spectrum disorder (including neuromyelitis optica) -

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

Neuromyelitis optica spectrum disorder (including neuromyelitis optica)

Classification by specialty

Medicine in general Neurology Ophthalmology

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

Safety will be reviewed during clinical use of Enspryng.
Safety specification: Infections, neutropenia, leukopenia, agranulocytosis, thrombocytopenia, hypersensitivity, impaired liver function, reactivation of hepatitis B virus, immunogenicity, cardiac disorder, malignant tumor, intestinal perforation, and interstitial pneumonia

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

1)Institution information: Name of institution, name of department, date CRF completed, name of physician completing CRF
2)Patient demographics: Patient initials, age at treatment initiation, ID number, sex, pregnancy, height, body weight, reason for use, details of neuromyelitis optica spectrum disorder (anti-AQP4 antibody, anti-MOG antibody, clinical signs, date of diagnosis, number of relapses within 2 years, expanded disability status scale [EDSS Score]), previous disease, concurrent disease, test of hepatitis B virus (HBs antigen, HBs antibody, HBc antibody), and previous treatment (immunosuppressive agent, other biological product)
3)Treatment status: Enspryng treatment status (daily dose, dosing schedule, treatment start date, treatment stop date), status at CRF completion (reason for discontinuation if treatment is discontinued)
4)Administration period of concomitant therapy: Corticosteroid other than steroid pulse therapy (treatment start date, treatment stop date), immunosuppressive agent (treatment start date, treatment stop date)
5)Treatment status of concomitant therapy (at start of treatment, every 6 months): Corticosteroid other than steroid pulse therapy (whether administered, drug name, administration route, daily dose), immunosuppressive agent (whether administered, drug name)
6)Relapse status (whether relapse occurs, date of relapse diagnosis, steroid pulse therapy [whether performed], plasmapheresis [whether performed])
7)Adverse event: Whether adverse event develops, name of adverse event or abnormal laboratory data*, date of occurrence, seriousness, intervention (Enspryng, other), outcome, date of outcome, causal relationship (Enspryng, other factors)

* For events that are considered to be potentially related to anti-Enspryng antibodies, anti-Enspryng antibodies will be tested as deemed necessary by physicians.

Key secondary outcomes

Base

Study type

Observational

Study design

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Eligibility

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Neuromyelitis optica spectrum disorder (including neuromyelitis optica)

Key exclusion criteria

None

Target sample size

330

Research contact person

Name of lead principal investigator

1st name Makoto

Middle name

Last name Nomura

Organization

Chugai Pharmaceutical Co. Ltd

Division name

Safety science Dept.

Zip code

1038324

Address

1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan

TEL

03-3281-6611

Email

nomuramkt@chugai-pharm.co.jp

Public contact

Name of contact person

1st name Ryousuke

Middle name

Last name Harada

Organization

Chugai Pharmaceutical Co. Ltd.

Division name

Safety Science Dept.

Zip code

1038324

Address

1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan

TEL

03-3281-6611

Homepage URL

Email

haradarus@chugai-pharm.co.jp

Sponsor or person

Institute

Chugai Pharmaceutical Co. Ltd.

Institute

Department

Personal name

Funding Source

Organization

Chugai Pharmaceutical Co. Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

None

Address

None

Tel

None

Email

None

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2020 Year 08 Month 26 Day

Related information

URL releasing protocol

Publication of results

Unpublished

Result

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

Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2020 Year 06 Month 30 Day

Date of IRB

2020 Year 06 Month 30 Day

Anticipated trial start date

2020 Year 08 Month 26 Day

Last follow-up date

2027 Year 02 Month 28 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

None

Management information

Registered date

2020 Year 07 Month 09 Day

Last modified on

2022 Year 12 Month 28 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046874

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name