UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048463 |
|---|---|
| Receipt number | R000054919 |
| Scientific Title | A Prospective Study to Evaluate Effectiveness of Upadacitinib in Moderate to Severe AD with Prurigo Nodules in the Real World in Japan |
| Date of disclosure of the study information | 2022/07/28 |
| Last modified on | 2023/12/21 09:19:47 |
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Basic information
Public title
A Prospective Study to Evaluate Effectiveness of Upadacitinib in Moderate to Severe AD with Prurigo Nodules in the Real World in Japan
Acronym
ADMIRE
Scientific Title
A Prospective Study to Evaluate Effectiveness of Upadacitinib in Moderate to Severe AD with Prurigo Nodules in the Real World in Japan
Scientific Title:Acronym
ADMIRE
Region
| Japan |
Condition
Condition
atopic dermatitis
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
What is the effectiveness of Upadacitinib for moderate to severe atopic dermatitis patients with prurigo nodules in the real world setting in Japan?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of participants achieving WP-NRS with >= 4 point reduction at Week 12
Key secondary outcomes
-Percentage of achieving EASI 75/90/100, EASI <= 1/7, vIGA-AD 0/1 and WP-NRS 0/1/<= 3/ reduction >= 4(except week 12 -primary outcome), POEM <= 2/<= 7/reduction >= 4, (c)DLQI 0/1/<= 5/reduction >= 4, ADCT < 7/reduction >= 5, IGA-CPG activity0/1 and IGA CNPG stage0/1 at all applicable time points
-Absolute score and change from baseline at all applicable time points in EASI, vIGA-AD, BSA, WP-NRS, POEM, (c)DLQI, ADCT, PN skin lesions as measured by IGA-CPG activity and IGA CNPG stage, skin pain NRS, Epworth Sleepiness Scale, the number of prurigo lesions in representative area, healed prurigo lesions, TSQM and WPAI-AD
-Time to achieve EASI 75/90/100, vIGA-AD 0/1, IGA-CPG activity 0/1, IGA CNPG stage0/1, WP-NRS 0/1, skin pain NRS 0/1, (c)DLQI0/1, POEM <= 2, and ADCT < 7
-Time-weighted EASI score, vIGA-AD score, IGA-CPG activity, IGA CNPG stage, the number of lesions in representative area, WP-NRS score, skin pain NRS, (c)DLQI and percentage of achieving Time-weighted EASI 75, EASI 90, EASI 100, vIGA-AD 0/1, IGA-CPG activity0/1,IGA CNPG stage0/1,WP-NRS 0/1, skin pain NRS 0/1, (c)DLQI0/1, POEM <= 2 and ADCT < 7
-Upadacitinib utilization patterns
Modification of Upadacitinib or concomitant AD therapy and associated timing, reasons. This includes Upadacitinib dose change, temporary or permanent discontinuation, switching, add or remove TCS.
-Adverse event
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. Physician confirmed diagnosis of atopic dermatitis at baseline
2. Atopic dermatitis symptom onset >= 1 year prior to baseline
3.Initiation of Upadacitinib treatment for AD is indicated and prescribed per the label in Japan independently of study participation
4.Patients who are >=12 years old at baseline
5. Patients who are WP-NRS >=4 at baseline
6. Patients who have palpable prurigo nodules at baseline
7.Patients who are explained about this study and provided signed informed consent prior to treatment with Upadacitinib
Key exclusion criteria
1. Patients who had prior treatment with Upadacitinib
2.Patients who have contraindications to Upadacitinib
3. Patients who have chronic pruritus resulting from another condition (e.g.,neuropathic disorders) than AD, prurigo nodules
4. Patients who have prurigo nodules caused by medication, metal allergy, infection, insect bite
5. Patients who are currently participating in interventional research or participated within 30 days (not including another post-marketing observational study, or registry participation).
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masayo |
| Middle name | |
| Last name | Hashimoto |
Organization
AbbVie GK
Division name
Medical, Medical Affairs-Immunology,Dermatology
Zip code
108-6302
Address
3-1-21,Shibaura,Minato-ku,Tokyo,Japan
TEL
03-4577-1111
ADMIRE@a2healthcare.com
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Ishido |
Organization
AbbVie GK
Division name
Medical, Medical Affairs-Immunology, Dermatology
Zip code
108-6302
Address
3-1-21,Shibaura,Minato-ku,Tokyo,Japan
TEL
03-4577-1111
Homepage URL
ADMIRE@a2healthcare.com
Sponsor or person
Institute
AbbVie GK
Institute
Department
Personal name
Funding Source
Organization
AbbVie GK
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
Nagasaki University Hospital Clinical Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT05451316
Org. issuing International ID_1
ClinicalTraial.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 07 | Month | 28 | 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
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Upadacitinib has been shown efficacy and safety in multiple Phase 3 clinical trials, in patients with moderate to severe AD, however, no evaluation has been performed to differentiate between patients with Prurigo-type AD. The objective of this prospective observational study is to evaluate the effectiveness of Upadacitinib for Prurigo-type AD Japanese patients in real world.
Management information
Registered date
| 2022 | Year | 07 | Month | 26 | Day |
Last modified on
| 2023 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054919
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
