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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022623
Receipt No. R000025749
Scientific Title Disease registry in Japanese adult patients with moderate-to-severe atopic dermatitis
Date of disclosure of the study information 2016/06/08
Last modified on 2019/08/19

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Basic information
Public title Disease registry in Japanese adult patients with moderate-to-severe atopic dermatitis
Acronym Japan AD Registry (ADDRESS-J)
Scientific Title Disease registry in Japanese adult patients with moderate-to-severe atopic dermatitis
Scientific Title:Acronym Japan AD Registry (ADDRESS-J)
Region
Japan

Condition
Condition Atopic dermatitis
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To describe the disease profile of patients with moderate-to-severe atopic dermatitis (AD) and current treatment practices evaluating the real-world effectiveness and safety.
Basic objectives2 Others
Basic objectives -Others Prospective, non-interventional, observational study
Trial characteristics_1 Others
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Flare (frequency, numbers, and time to first flare from baseline visit) will be determined by totaling data every 3 months and during the 2-year observation period.
Key secondary outcomes Each of the following items: Every 3 months data point and at unscheduled visits
-Observed value, change and percent change in IGA score
-Observed value, change and percent change in EASI score
-Observed value, change and percent change in Pruritus NRS (on an 11-point scale between 0 and 10)
-Observed value and change in percentages of BSA involvement
-Condition of nodular prurigo:
(i) Present/absent (0: Absent, 1: Present)
(ii) Number (1: <10, 2: >=10 and <100, 3: >=100)
(iii) Maximum size of each prurigo (0: Generally <2 mm in diameter, 1: Generally >=2 mm and <4 mm in diameter, 2: Generally >=4 mm and <8 mm in diameter, 3: Generally >=8 mm)
-Measured value and change in TARC levels, blood eosinophil counts, IgE levels, and LDH levels

Proportion of treatment responders which are defined as below: Every 3 months data point
-IGA score of 0 or 1 (on a 5-point scale) and a reduction from baseline of >=2 points
-EASI-75 (>=75% reduction in EASI score from baseline) is achieved
-Improvement (reduction) in Pruritus NRS of >=4 points from baseline

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
20 years-old <=
Age-upper limit
60 years-old >
Gender Male and Female
Key inclusion criteria 1. Japanese patient who have had a diagnosis of AD according to the guideline entitled "Definition and diagnosis criteria for atopic dermatitis" (the Japanese Dermatological Association) at least 6 months before the baseline visit.
2. Investigator's Global Assessment (IGA) score of at least 3 at the baseline visits
3. Start any of the following treatments* at the baseline visit
(i) Newly start AD medications (topical/oral corticosteroids or topical/oral immunosuppressant) , including changes to the higher class of topical corticosteriods (TCS)]
(ii) Increase the dose of AD medication (topical/oral corticosteroids or topical/oral immunosuppressant ) which is currently being used
(iii) Thorough implementation of the standard care for AD medication (topical/oral corticosteroids or topical/oral immunosuppressant ): patient education**

* Ultraviolet irradiation or anti-histamine/anti-allergic drugs are excluded.
** Brief instructions on treatment usually provided on a routine outpatient basis will not be regarded as patient education.
Key exclusion criteria 1. Treatment with an investigational drug within 8 weeks before the baseline visit
2. Presence of skin comorbidities that may interfere with study assessments
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Norito
Middle name
Last name Katoh
Organization Kyoto Prefectural University of Medicine
Division name Department of Dermatology
Zip code 602-8566
Address 465 Kajii-cho, Kawaramachi Hirokoji, Kamigyo-ku, Kyoto-fu, Japan
TEL 075-251-5586
Email nkatoh@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name for clinical study
Middle name
Last name Public contact
Organization Sanofi K.K.
Division name Medical Affairs
Zip code 163-1488
Address Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL 03-6301-4575
Homepage URL
Email Sanofi_Medical@sanofi.com

Sponsor
Institute Sanofi K.K.
Institute
Department

Funding Source
Organization Sanofi K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board, Kyoto Prefectural University of Medicine
Address 465 Kajii-cho, Kawaramachi Hirokoji, Kamigyo-ku, Kyoto-fu 602-8566, Japan
Tel 075-251-5337
Email rinri@koto.kpu-m.ac.jp

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 京都府立医科大学附属病院(京都府)、ほか

Other administrative information
Date of disclosure of the study information
2016 Year 06 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 300
Results
Katoh et al. Current status of moderate-to-severe atopic dermatitis in the Japanese adult population: Rationale and design of a prospective registry study. JDA 2016, Kyoto.

Katoh et al. Current status of moderate-to-severe atopic dermatitis in Japan: Baseline characteristics of prospective registry study cohort. JDA 2018, Hiroshima.

Saeki et al. Current status of atopic dermatitis in Japan (ADDRESS-J): One-year interim analysis. JDA 2019, Nagoya.

3 more abstracts were presented.
Results date posted
2019 Year 06 Month 10 Day
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 Completed
Date of protocol fixation
2016 Year 04 Month 28 Day
Date of IRB
2016 Year 07 Month 12 Day
Anticipated trial start date
2016 Year 07 Month 29 Day
Last follow-up date
2019 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Safety

Adverse event (AE) whose causal relationship with AD treatment cannot be excluded, AE leading to any AD treatment discontinuation, Serious AE (SAE), Skin infection AE that needs additional treatment, Body weight, Clinical laboratory test

Management information
Registered date
2016 Year 06 Month 06 Day
Last modified on
2019 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025749

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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