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 Type
OBSERVATIONAL
Enrollment
60
NHO Nagoya Medical Center /ID# 246013
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital /ID# 233778
Nagoya, Aichi-ken, Japan
Akita University Hospital /ID# 242706
Akita, Akita, Japan
Kyushu University Hospital /ID# 247492
Fukuoka, Fukuoka, Japan
Japanese Red Cross Fukuoka Hospital /ID# 244051
Fukuoka, Fukuoka, Japan
Kurume University Hospital /ID# 246502
Kurume-shi, Fukuoka, Japan
Central Japan International Medical Center /ID# 239391
Minokamo-shi, Gifu, Japan
Gunma University Hospital /ID# 239390
Maebashi, Gunma, Japan
Sapporo Medical University Hospital /ID# 241180
Sapporo, Hokkaido, Japan
Hokkaido University Hospital /ID# 252567
Sapporo, Hokkaido, Japan
...and 36 more locations
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
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