An observational study in Pyoderma Gangrenosum, sponsored by AbbVie. Completed at 46 sites in Japan. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2025-07-17.
Sponsored by AbbVie · Observational
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.
Patients
Exclusion Criteria:
- Have Pyoderma Gangrenosum (PG) in previous treatment with Humira.
Participants receiving Adalimumab for Pyoderma Gangrenosum (PG).
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.
Time frame: Up to 52 weeks
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.
Time frame: 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.
Time frame: Up to 52 weeks
Change in Physician's Global Assessment (PGA) [Global] Grade
PGA will be used for overall assessment of efficacy.
Time frame: Up to Week 52
Change in PGA [Target] Grade
PGA will be used for assessment of efficacy of target lesions.
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 52
Percentage of Participants with Recurrence
Recurrence of PG.
Time frame: Up to Week 52
Time to Recurrence (Day)
Recurrence of PG.
Time frame: Up to Week 52
Percentage of PG Subtype at Recurrence
Recurrence of PG. PG subtypes include (ulcerative (including peristomal), bullous, pustular, vegetative).
Time frame: 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.
Time frame: Week 26 to Week 52
Plan to share: Undecided
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AbbVie