A Study to Assess Adverse Events and Change in Disease State in Adult Participants Being Treated With Humira in Participants Diagnosed With Pyoderma Gangrenosum (PG)

Study Overview
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Brief Summary
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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.

Official Title
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Post-marketing Observational Study for Humira in Participants Diagnosed With Pyoderma Gangrenosum (PG)

Conditions
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Pyoderma Gangrenosum

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants Receiving Humira (Adalimumab)<br>Participants receiving Adalimumab for Pyoderma Gangrenosum (PG). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Percentage of all the Infection Reported as Adverse Drug Reaction (ADR) | 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. | Up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Percentage of Serious Infection Reported as ADR | 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. | Up to 52 weeks | 
| Incidence Percentage of each ADR (Besides Infection) | 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. | Up to 52 weeks | 
| Change in Physician's Global Assessment (PGA) [Global] Grade | PGA will be used for overall assessment of efficacy. | Up to Week 52 | 
| Change in PGA [Target] Grade | PGA will be used for assessment of efficacy of target lesions. | Up to Week 52 | 
| Change in Investigator Inflammation Assessment (IIA) Score from Start of Dosing | IIA will be used for assessment of efficacy of target lesions. | Up to Week 52 | 
| Change in Verbal Rating Scale (VRS) Category | Pain improvement will be assessed using a VRS scale 0-3 with a lower score indicating less pain. | Up to Week 52 | 
| Percentage of Participants with Recurrence | Recurrence of PG. | Up to Week 52 | 
| Time to Recurrence (Day) | Recurrence of PG. | Up to Week 52 | 
| Percentage of PG Subtype at Recurrence | Recurrence of PG. PG subtypes include (ulcerative (including peristomal), bullous, pustular, vegetative). | Up to Week 52 | 
| Pain Improvement Assessed with VRS | Pain improvement will be assessed using a VRS scale 0-3 with a lower score indicating less pain. | Week 26 to Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Humira, Pyoderma Gangrenosum, Adalimumab