A Multicenter, Large-sample Case Registry Study to Evaluate Patient-reported Outcome and Medication Patterns With Vunakizumab for Inflammatory Skin Diseases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 10,000
- Primary Endpoint
- Change from baseline in DLQI scores over 52 weeks
Study Overview
Brief Summary
This is a national multi-center, large sample size case registration clinical study. The registry population was patients with inflammatory skin diseases who were receiving treatment with vunakizumab. All outpatient and inpatient patients with inflammatory skin diseases who were receiving vunakizumab were eligible for enrollment. Patients' usual care was not affected by participation in the study. We only collected data in routine clinical practice.
The study had an enrollment period of 5 years or 10,000 patients were recruited early, whichever occurred first. All patients must provide written informed consent form before data collection, and each patient will be followed for 1 year to observe clinical progression.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •aged ≥ years；
- •had adiagnosis of inflammatory skin disease；
- •Is receiving or plans to receive vunakizumab for treatment;
- •Patients provided written informed consent form.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change from baseline in DLQI scores over 52 weeks
Time Frame: Weeks 0 to 52
DLQI: Dermatology Life Quality Index, range from 0 to 30, with higher scores indicating greater impact on quality of life
Secondary Outcomes
- Change from baseline in BSA over 52 weeks(Weeks 0 to 52)
- Patterns of administration of vunakizumab for the treatment of different inflammatory skin diseases(Weeks 0 to 52)
- Change from baseline in IGA over 52 weeks(Weeks 0 to 52)