UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027783
Receipt number R000031837
Scientific Title An interventional study to assess patient-reported outcome measures in bradalumab treated patients with moderate to severe plaque psoriasis in Japan
Date of disclosure of the study information 2017/06/16
Last modified on 2020/05/14 10:41:12

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Basic information

Public title

An interventional study to assess patient-reported outcome measures in bradalumab treated patients with moderate to severe plaque psoriasis in Japan

Acronym

PROMs in brodalumab treated patients with psoriasis in Japan

Scientific Title

An interventional study to assess patient-reported outcome measures in bradalumab treated patients with moderate to severe plaque psoriasis in Japan

Scientific Title:Acronym

PROMs in brodalumab treated patients with psoriasis in Japan

Region

Japan


Condition

Condition

psoriasis

Classification by specialty

Dermatology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objectives of the study are to evaluate the clinical efficacy of bradalumab for disease severity of psoriasis and to assess the change of patient-reported outcomes in brodalumab treated patients with moderate to severe plaque psoriasis without joint symptoms in Japan.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Mean Change From Baseline on the Psoriasis Area and Severity Index (PASI) and in Percent Body Surface Area (%BSA) [Time Frame: Week 12, 48]
Proportion of Participants Achieving PASI 75, 90 and PASI 100 [Time Frame: Week 12, 48]
Mean Change From Baseline on EuroQol - 5 Dimension - 5 Level, Dermatology Life Quality Index, Patient Health Questionnaire - 8, Generalized Anxiety Disorder - 7, Itch Numerical Rating Scale, Skin Pain Numerical Rating Scale, Medical Outcomes Study Sleep Scale, Work Productivity and Activity Impairment-Psoriasis and Treatment Satisfaction Questionnaire for Medication-9 [Time Frame: Week 12, 48]
Patient Global Assessment [Time Frame: Week 12, 48]

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administer subcutaneously 210 mg as brodalumab in the first dose, followed by doses at 1 week later, 2 weeks later, and once every 2 weeks thereafter.
In this study, the research duration will be 48 weeks

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Patients with plaque psoriasis who aged 18 years or older at the time of informed concent.
2)Patients who have given written informed consect to participate.
3)Patients who are judged to be able to inject oneself with brodalumab by the investigator or subinvestigator at the time of informed concent.
4)Patients who responded inadequately to phototherapies or other existing systemic therapies (except biologics) and who have skin eruptions over 10% or more of the body surface area at enrollment.
5)Patients who were carefully deemed by the investigator or subinvestigator not to continue the treatment protocol with prior biologic(s).

Key exclusion criteria

1)Patients with psoriatic erythroderma, pustular psoriasis and guttate psoriasis at the time of informed concent.
2)Patients with a severe infection or active tuberculosis at the time of informed concent.
3)Patients who are judged by the investigator or subinvestigator to be unsuitable for participation in this study.
4)Patients with joint symptoms at enrollment.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Shinichi
Middle name
Last name Imafuku

Organization

Fukuoka University Hospital

Division name

Department of Dermatology

Zip code

814-0180

Address

7-45-1 Nanakuma, Jonan-ku, Fukuoka

TEL

092-801-1011

Email

dermatologist@mac.com


Public contact

Name of contact person

1st name Kenji
Middle name
Last name Kaneko

Organization

Kyowa Hakko Kirin Co., Ltd

Division name

Medical Affairs

Zip code

100-0004

Address

1-9-2 Otemachi, Chiyoda-ku, Tokyo

TEL

03-5205-7200

Homepage URL


Email

ma.cre@kyowa-kirin.co.jp


Sponsor or person

Institute

Kyowa Hakko Kirin Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

Kyowa Hakko Kirin 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

Institutional Review Board of Nippon Medical School Foundation

Address

Tokyo 1-1-5 Sendagi, Bunkyo-ku, Tokyo

Tel

03-5802-8202

Email

officetokutei@nms.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

jRCTs031180037

Org. issuing International ID_1

jRCT

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 06 Month 16 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

74

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

Terminated

Date of protocol fixation

2017 Year 06 Month 15 Day

Date of IRB

2017 Year 10 Month 02 Day

Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date

2020 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Transfer to jRCT


Management information

Registered date

2017 Year 06 Month 16 Day

Last modified on

2020 Year 05 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031837


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name