UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054106 |
|---|---|
| Receipt number | R000061308 |
| Scientific Title | Retrospective Observational Study of Atopic Dermatitis Patient After Achieving Remission by Upadacitinib in Japanese Real-world Practice |
| Date of disclosure of the study information | 2024/04/12 |
| Last modified on | 2026/06/09 08:40:30 |
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Basic information
Public title
Retrospective observational study of patients with atopic dermatitis in remission with Upadacitinib.
Acronym
ROADMAP study
Scientific Title
Retrospective Observational Study of Atopic Dermatitis Patient After Achieving Remission by Upadacitinib in Japanese Real-world Practice
Scientific Title:Acronym
ROADMAP study
Region
| Japan |
Condition
Condition
Atopic Dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the actual treatment status of patients with atopic dermatitis who have achieved remission with Upadacitinib in real-life clinical practice and the course of treatment, including the duration of maintenance of remission.
Basic objectives2
Others
Basic objectives -Others
Collection of information on proper use of Upadacitinib.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Remission maintenance rate at 1 year after achieving remission with Upadacitinib
Key secondary outcomes
Upadacitinib for atopic dermatitis: the actual treatment of atopic dermatitis.
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) AD patients receiving upadacitinib for the treatment of AD
2) Patients aged 12 years or older at the start of treatment with Upadacitinib
3) Patients who achieved remission after treatment with Upadacitinib
4) Patients who can be followed up for at least 1 year after remission
Key exclusion criteria
1) Cases of use clearly off-label for Upadacitinib
2) Patients who have requested to refuse to participate in the study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | YUICHIRO |
| Middle name | |
| Last name | TSUNEMI |
Organization
Saitama Medical University Hospital
Division name
Department of Dermatology
Zip code
3500495
Address
38 Morohongo, Moroyama-cho, Iruma-gun, Saitama
TEL
049-276-1111
crt-info@ebc-m.com
Public contact
Name of contact person
| 1st name | RYOICHI |
| Middle name | |
| Last name | TAGUCHI |
Organization
EBC&M LLC
Division name
Clinical Division
Zip code
1050011
Address
Shibamatsuobiru 4F, 2-9-1 Shibakoen, Minato-ku, Tokyo-to
TEL
0364353833
Homepage URL
ryoichi_taguchi@ebc-m.com
Sponsor or person
Institute
Non-Profit Organization Health Institute Research of Skin
Institute
Department
Personal name
Funding Source
Organization
Non-Profit Organization Health Institute Research of Skin
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Abbvie LLC.
Name of secondary funder(s)
Abbvie LLC.
IRB Contact (For public release)
Organization
Nonprofit Organization Skin Health Research Organization
Address
Fukuda Bldg. 2F, 1-8-9 Uchikanda, Chiyoda-ku, Tokyo-to
Tel
03-3256-2575
shinsa@npo-hifu.net
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 12 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1111/1346-8138.70299
Publication of results
Unpublished
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1111/1346-8138.70299
Number of participants that the trial has enrolled
300
Results
75% of patients achieved UPA remission within 4 months. Over the next 48 weeks, 63.5% maintained it. The 48-week maintenance rates were 64.1% for on-label and 75.0% for spacing/reduction, versus 37.5% for discontinuation. At week 72, rates were 70.7%, 100%, and 60.0%, respectively. Longer on-label treatment before tapering lowered relapse risk.
Results date posted
| 2026 | Year | 06 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study included 219 patients aged $\ge$ 12 years with moderate-to-severe atopic dermatitis in Japan who achieved protocol-defined remission during upadacitinib (UPA) treatment. Remission was defined as an Investigator's Global Assessment (IGA) score of 0 or 1 at two separate routine clinical visits at least 4 weeks apart.
Participant flow
Of the 219 enrolled patients, 75% achieved remission within about 4 months of starting UPA. Over the subsequent 48 weeks, 127 out of 200 evaluable patients (63.5%) maintained remission. For the post-remission strategy analysis, 193 patients were evaluated (excluding 7 who switched to other systemic therapies): 145 patients in the on-label (continuous) group, 32 in the spacing/reduction group, and 16 in the discontinuation group. Among these, a cohort with $\ge$ 24 weeks of sustained remission entered the long-term flow for week-72 assessment, comprising 107 in the on-label group, 8 in the spacing/reduction group, and 5 in the discontinuation group.
Adverse events
The safety profile of UPA in this real-world study was consistent with findings from previous clinical trials. The most frequently reported adverse events were acne, herpes simplex, herpes zoster, and folliculitis. The majority of these events were mild and clinically manageable. In terms of severity, one case of herpes zoster required temporary interruption of UPA treatment for management, but no new or unexpected safety concerns were identified in this cohort.
Outcome measures
The primary endpoint was the maintenance rate of remission (IGA 0/1) over 48 weeks after achieving initial remission. Key secondary endpoints included the time to relapse, clinical outcomes after treatment modification, long-term remission maintenance rates at week 72 among patients who experienced $\ge$ 24 weeks of sustained remission, and safety assessments.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 02 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 29 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective observational study(no invasive)
Management information
Registered date
| 2024 | Year | 04 | Month | 10 | Day |
Last modified on
| 2026 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061308
