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Japanese

April. 27, 2026

June. 03, 2026

jRCT1030260092

Atopic deRMAtitis DiseAse registry of ADult and adolescent patients initiating or switching systemic treatments (ARMADA-AD) (ARMADA-AD)

Atopic deRMAtitis DiseAse registry of ADult and adolescent patients initiating or switching systemic treatments (ARMADA-AD) (ARMADA-AD)

Sugiyama Shigeru

Sanofi K.K.

Tokyo opera city tower,3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo

+81-3-6301-3000

Sanofi_ARMADA_Japan@iqvia.com

Shimomoto Waka

IQVIA Services Japan G.K.

Keikyu Dai-ichi Bldg 4-10-18, Takanawa, Minato-k u, Tokyo

+81-90-8655-6223

waka.shimomoto@iqvia.com

Recruiting

April. 27, 2026

1000

Observational

non-randomized controlled trial

open(masking not used)

no treatment control/standard of care control

single assignment

other

- Patients aged >=12 years at the time of consent
- Confirmed diagnosis of AD, of any severity, according to the Investigators assessment as aligned with International Classification of Diseases 10th revision (ICD-10) code of L20
- Prescribed and scheduled to initiate any systemic treatment for AD (including but not limited to biologics, oral JAK inhibitors, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil)
- Signed informed consent for registry participation by the patient or parent-legal representative and assent by the patient appropriate to the patients age, including willingness to participate in long-term follow-up

- Concurrent participation in an interventional clinical trial that administers an investigational drug that modifies patient care
- Insufficient understanding of the study by the patient and-or parent/guardian

12age old over
No limit

Both

Atopic Dermatitis

D003876

To describe the utilization patterns of systemic therapy for atopic dermatitis (AD) from baseline and over the follow-up period
To describe clinical outcomes of treatment with systemic therapy for AD measured using clinical reported outcomes (ClinROs) and patient-reported outcomes (PROs) from baseline and over the follow-up period

To describe participant sociodemographic and clinical characteristics at baseline
To describe quality of life, depression, productivity, and treatment satisfaction while being treated with systemic therapy for AD using PROs from baseline and over follow-up
To describe health care resource utilization from baseline and over the follow-up period
To evaluate selected comorbid atopic and non-atopic conditions at baseline and over the follow-up period
To describe concomitant medication use for AD and selected comorbidities at baseline and over follow-up
Describe the incidence of AEs and serious adverse events (SAE) while on systemic treatment
Describe the occurrence of AEs and SAEs over the follow-up period

Sanofi Aventis Recherche & Developpement
Non-Profit Organization MINS Institutional Review Board
20-9-401, Mita 5cho-me, Minato-ku, Tokyo

+81-3-6416-1868

npo-mins@j-irb.com
Approval

Oct. 16, 2025

Yes

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

NCT07290803
ClinicalTrials.gov

History of Changes

No Publication date
2 June. 03, 2026 (this page) Changes
1 April. 27, 2026 Detail