Pyoderma Gangrenosum
Conditions
Keywords
Pyoderma Gangrenosum, Humira, Adalimumab
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Percentage of all the Infection Reported as Adverse Drug Reaction (ADR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence Percentage of each ADR (Besides Infection) | Up to 52 weeks | An 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. |
| Change in Physician's Global Assessment (PGA) [Global] Grade | Up to Week 52 | PGA will be used for overall assessment of efficacy. |
| Change in PGA [Target] Grade | Up to Week 52 | PGA will be used for assessment of efficacy of target lesions. |
| Change in Investigator Inflammation Assessment (IIA) Score from Start of Dosing | Up to Week 52 | IIA will be used for assessment of efficacy of target lesions. |
| Incidence Percentage of Serious Infection Reported as ADR | Up to 52 weeks | An 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. |
| Percentage of Participants with Recurrence | Up to Week 52 | Recurrence of PG. |
| Time to Recurrence (Day) | Up to Week 52 | Recurrence of PG. |
| Percentage of PG Subtype at Recurrence | Up to Week 52 | Recurrence of PG. PG subtypes include (ulcerative (including peristomal), bullous, pustular, vegetative). |
| Pain Improvement Assessed with VRS | Week 26 to Week 52 | Pain improvement will be assessed using a VRS scale 0-3 with a lower score indicating less pain. |
| Change in Verbal Rating Scale (VRS) Category | Up to Week 52 | Pain improvement will be assessed using a VRS scale 0-3 with a lower score indicating less pain. |
Countries
Japan
Outcome results
None listed