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 2024/07/22 07:03:52

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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

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

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) -

Scientific Title:Acronym

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

Region

Japan


Condition

Condition

Neuromyelitis optica spectrum disorder (including neuromyelitis optica)

Classification by specialty

Medicine in general Neurology Ophthalmology

Classification by malignancy

Others

Genomic information

NO


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 Shinya
Middle name
Last name Takemoto

Organization

Chugai Pharmaceutical Co. Ltd

Division name

Safety science 2 Dept.

Zip code

1038324

Address

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

TEL

03-3281-6611

Email

takemotosny@chugai-pharm.co.jp


Public contact

Name of contact person

1st name Ayako
Middle name
Last name Murayama

Organization

Chugai Pharmaceutical Co. Ltd.

Division name

Safety Science 2 Dept.

Zip code

1038324

Address

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

TEL

03-3281-6611

Homepage URL


Email

murayamaayk@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

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

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

Partially published


Result

URL related to results and publications

https://link.springer.com/article/10.1007/s40120-024-00640-7

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

2024 Year 07 Month 22 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