UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022623
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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Sanofi K.K.

Institute

Department

Personal name



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

Value
https://center6.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