Long-term Follow-up Study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Not applicable(observational study).
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Long-term Follow-up Study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis: 5-year Results From the K0104 Extension Study
Overview
A multi-center, open, long-term follow-up study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD inj. for Moderate to Severe Chronic Atopic Dermatitis: 5-year Results from the K0104 Extension Study
Interventions
- Other Not applicable(observational study)
Not applicable(observational study)
Primary outcome measures
- Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event) [Time frame: for 5 years]
Secondary outcome measures (12)
- Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50) [Time frame: for 5 years]
- Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75) [Time frame: for 5 years]
- Rate of change and Change in EASI from baseline [Time frame: for 5 years]
- Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1 [Time frame: for 5 years]
- Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher [Time frame: for 5 years]
- Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50) [Time frame: for 5 years]
- Rate of change and Change in SCORAD index from baseline at each visit [Time frame: for 5 years]
- Change and rate of change in Body Surface Area (BSA) [Time frame: for 5 years]
- Change and rate of change in total serum Immunoglobulin E (IgE) [Time frame: for 5 years]
- Change and rate of change DLQI [Time frame: for 5 years]
- Change and rate of change POEM [Time frame: for 5 years]
- Change and rate of change Peak Pruritus NRS [Time frame: for 5 years]
Eligibility criteria
Inclusion criteria
- Subject who enrolled K0104 Clinical Trial(parent study).
- Subjects who understand and voluntarily sign an informed consent form
Exclusion criteria
- Subjects who are expected to be unable to perform at least one follow-up during this study (K0104-E)
- Subjects who has received/administered clinical trial drugs or medical devices by participating in other clinical trials until the first visit of this trial (K0104-E) after the completion of K0104 clinical trial
- Subjects who are judged to be unsuitable for other researchers to participate in the research
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
South Korea · 1 center
- Dongguk University Medical Center — Ilsan
Identifiers
NCT: NCT04730024 · K0104-E