Unique ID issued by UMIN | UMIN000022623 |
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Receipt number | 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 13:50:51 |
Disease registry in Japanese adult patients with moderate-to-severe atopic dermatitis
Japan AD Registry (ADDRESS-J)
Disease registry in Japanese adult patients with moderate-to-severe atopic dermatitis
Japan AD Registry (ADDRESS-J)
Japan |
Atopic dermatitis
Dermatology |
Others
NO
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.
Others
Prospective, non-interventional, observational study
Others
Explanatory
Not applicable
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.
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
Observational
20 | years-old | <= |
60 | years-old | > |
Male and Female
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.
1. Treatment with an investigational drug within 8 weeks before the baseline visit
2. Presence of skin comorbidities that may interfere with study assessments
300
1st name | Norito |
Middle name | |
Last name | Katoh |
Kyoto Prefectural University of Medicine
Department of Dermatology
602-8566
465 Kajii-cho, Kawaramachi Hirokoji, Kamigyo-ku, Kyoto-fu, Japan
075-251-5586
nkatoh@koto.kpu-m.ac.jp
1st name | for clinical study |
Middle name | |
Last name | Public contact |
Sanofi K.K.
Medical Affairs
163-1488
Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan
03-6301-4575
Sanofi_Medical@sanofi.com
Sanofi K.K.
Sanofi K.K.
Profit organization
Japan
Institutional Review Board, Kyoto Prefectural University of Medicine
465 Kajii-cho, Kawaramachi Hirokoji, Kamigyo-ku, Kyoto-fu 602-8566, Japan
075-251-5337
rinri@koto.kpu-m.ac.jp
NO
京都府立医科大学附属病院(京都府)、ほか
2016 | Year | 06 | Month | 08 | Day |
Partially published
300
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.
2019 | Year | 06 | Month | 10 | Day |
Completed
2016 | Year | 04 | Month | 28 | Day |
2016 | Year | 07 | Month | 12 | Day |
2016 | Year | 07 | Month | 29 | Day |
2019 | Year | 07 | Month | 31 | Day |
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
2016 | Year | 06 | Month | 06 | Day |
2019 | Year | 08 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025749
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