Post-marketing Observational Study for Humira in Participants Diagnosed With Pyoderma Gangrenosum (PG)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 46
- Primary Endpoint
- Incidence Percentage of all the Infection Reported as Adverse Drug Reaction (ADR)
Study Overview
Brief Summary
Pyoderma Gangrenosum (PG) is a rapidly progressive disease and presents as painful, single or multiple lesions, with several clinical variants, in different locations, with a nonspecific histology, which makes the diagnosis challenging and often delayed. The main objective of this study is to estimate the incidence proportion of all the infection reported as adverse drug reaction (ADR) of Humira with PG participants.
Humira is the only drug approved for the treatment of Pyoderma Gangrenosum (PG) in Japan. Approximately 60 adult participants with PG at approximately 60 sites in Japan.
Participants will receive injectable Humira (Adalimumab) as prescribed by the physician prior to enrolling in this study.
There may be a higher burden for participants in this study compared to standard of care. Participants will attend regular visits per routine clinical practice. The effect of the treatment will be checked by medical assessments, checking for side effects, and by verbal interview.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with Pyoderma Gangrenosum (PG).
- •Have been prescribed Humira for PG treatment within 14 days.
Exclusion Criteria
- •Have Pyoderma Gangrenosum (PG) in previous treatment with Humira.
Outcomes
Primary Outcomes
Incidence Percentage of all the Infection Reported as Adverse Drug Reaction (ADR)
Time Frame: Up to 52 weeks
An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.
Secondary Outcomes
- Change in Verbal Rating Scale (VRS) Category(Up to Week 52)
- Incidence Percentage of Serious Infection Reported as ADR(Up to 52 weeks)
- Change in Investigator Inflammation Assessment (IIA) Score from Start of Dosing(Up to Week 52)
- Time to Recurrence (Day)(Up to Week 52)
- Pain Improvement Assessed with VRS(Week 26 to Week 52)
- Incidence Percentage of each ADR (Besides Infection)(Up to 52 weeks)
- Percentage of Participants with Recurrence(Up to Week 52)
- Change in PGA [Target] Grade(Up to Week 52)
- Percentage of PG Subtype at Recurrence(Up to Week 52)
- Change in Physician's Global Assessment (PGA) [Global] Grade(Up to Week 52)