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)
- Conditions
- Pyoderma Gangrenosum
- Registration Number
- NCT04750213
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Diagnosed with Pyoderma Gangrenosum (PG).
- Have been prescribed Humira for PG treatment within 14 days.
- Have Pyoderma Gangrenosum (PG) in previous treatment with Humira.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
Time to Recurrence (Day) Up to Week 52 Recurrence of PG.
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.
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.
Percentage of Participants with Recurrence Up to Week 52 Recurrence of PG.
Change in PGA [Target] Grade Up to Week 52 PGA will be used for assessment of efficacy of target lesions.
Percentage of PG Subtype at Recurrence Up to Week 52 Recurrence of PG. PG subtypes include (ulcerative (including peristomal), bullous, pustular, vegetative).
Change in Physician's Global Assessment (PGA) [Global] Grade Up to Week 52 PGA will be used for overall assessment of efficacy.
Trial Locations
- Locations (46)
Nagoya City University Hospital /ID# 233778
🇯🇵Nagoya shi, Aichi, Japan
NHO Nagoya Medical Center /ID# 246013
🇯🇵Nagoya-shi, Aichi, Japan
Akita University Hospital /ID# 242706
🇯🇵Akita-shi, Akita, Japan
Kyushu University Hospital /ID# 247492
🇯🇵Fukuoka-shi, Fukuoka, Japan
Japanese Red Cross Fukuoka Hospital /ID# 244051
🇯🇵Fukuoka-shi, 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-shi, Gunma, Japan
Hokkaido University Hospital /ID# 252567
🇯🇵Sapporo-shi, Hokkaido, Japan
Hokkaido Medical Center /ID# 251657
🇯🇵Sapporo-shi, Hokkaido, Japan
Scroll for more (36 remaining)Nagoya City University Hospital /ID# 233778🇯🇵Nagoya shi, Aichi, Japan