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
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
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
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
