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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027783
Receipt No. 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 2019/07/05

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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
Institute Kyowa Hakko Kirin Co., Ltd
Institute
Department

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

Management information
Registered date
2017 Year 06 Month 16 Day
Last modified on
2019 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.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


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