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
- RECRUITING
- 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)
Kumamoto University Hospital /ID# 244050
๐ฏ๐ตKumamoto shi, Kumamoto, Japan
Okinawa Kyodo Hospital /ID# 241739
๐ฏ๐ต้ฃ่ฆๅธ, Okinawa, Japan
Japanese Red Cross Osaka Hospital /ID# 228782
๐ฏ๐ตOsaka-shi, Osaka, Japan
Fukuchiyama City Hospital /ID# 246593
๐ฏ๐ตFukuchiyama-shi, Japan
Okayama University Hospital /ID# 238746
๐ฏ๐ตOkayama, Japan
Hokkaido Medical Center /ID# 251657
๐ฏ๐ตSapporo-shi, Japan
Kurume University Hospital /ID# 246502
๐ฏ๐ตKurume-shi, Fukuoka, Japan
Kyushu University Hospital /ID# 247492
๐ฏ๐ตFukuoka-shi, Fukuoka, Japan
Sapporo Medical University Hospital /ID# 241180
๐ฏ๐ตSapporo-shi, Hokkaido, Japan
Kansai Rosai Hospital /ID# 246592
๐ฏ๐ตAmagasaki-shi, Hyogo, Japan
Nagoya City University Hospital /ID# 233778
๐ฏ๐ตNagoya shi, Aichi, Japan
NHO Nagoya Medical Center /ID# 246013
๐ฏ๐ตNagoya-shi, Aichi, Japan
Hokkaido University Hospital /ID# 252567
๐ฏ๐ตSapporo-shi, Hokkaido, Japan
Akita University Hospital /ID# 242706
๐ฏ๐ตAkita-shi, Akita, Japan
Nara Medical University Hospital /ID# 241880
๐ฏ๐ตKashihara-shi, Nara, Japan
Hamamatsu University Hospital /ID# 240817
๐ฏ๐ตHamamatsu-shi, Shizuoka, Japan
Teikyo University /ID# 239389
๐ฏ๐ตTokyo, Japan
Yamanashi Kosei Hospital /ID# 242168
๐ฏ๐ตYamanashi City, Yamanashi, Japan
Ishikawa Prefectural Central Hospital /ID# 239089
๐ฏ๐ตKanazawa-shi, Ishikawa, Japan
Naha City Hospital /ID# 240818
๐ฏ๐ตNaha, Okinawa, Japan
Kansai Medical University Hospital /ID# 228783
๐ฏ๐ตHirakata-shi, Osaka, Japan
Tokyo Medical University Hospital /ID# 233780
๐ฏ๐ตShinjuku-ku, Tokyo, Japan
Kanazawa University Hospital /ID# 248730
๐ฏ๐ตKanazawa-shi, Ishikawa, Japan
Kagawa Prefectural Central Hospital /ID# 250193
๐ฏ๐ตTakamatsu-shi, Kagawa, Japan
Yokohama Municipal Citizen's Hospital /ID# 233779
๐ฏ๐ตYokohama-shi, Kanagawa, Japan
Kindai University Hospital /ID# 252568
๐ฏ๐ตOsakasayama-shi, Osaka, Japan
Takatsuki General Hospital /ID# 244694
๐ฏ๐ตOsaka, Japan
The Jikei University Hospital /ID# 252112
๐ฏ๐ตMinato-ku, Tokyo, Japan
Teikyo University Mizonokuchi Hospital /ID# 244693
๐ฏ๐ตKawasaki, Kanagawa, Japan
University of Miyazaki Hospital /ID# 241179
๐ฏ๐ตMiyazaki-shi, Miyazaki, Japan
Japanese Red Cross Fukuoka Hospital /ID# 244051
๐ฏ๐ตFukuoka-shi, Fukuoka, Japan
Central Japan International Medical Center /ID# 239391
๐ฏ๐ตMinokamo-shi, Gifu, Japan
Gunma University Hospital /ID# 239390
๐ฏ๐ตMaebashi-shi, Gunma, Japan
Nishi-Kobe Medical Center /ID# 244224
๐ฏ๐ตKobe-shi, Hyogo, Japan
Kobe University Hospital /ID# 249396
๐ฏ๐ตKobe, Hyogo, Japan
Takamatsu Red Cross Hospital /ID# 240576
๐ฏ๐ตTakamatsu-shi, Kagawa, Japan
Yokohama Minami Kyousai Hosp /ID# 252892
๐ฏ๐ตYokohama-shi, Kanagawa, Japan
Mie University Hospital /ID# 238747
๐ฏ๐ตTsu-shi, Mie, Japan
Tohoku Medical and Pharmaceuti /ID# 230270
๐ฏ๐ตSendai-shi, Miyagi, Japan
Tohoku University Hospital /ID# 252113
๐ฏ๐ตSendai-shi, Miyagi, Japan
Shinshu University Hospital /ID# 230272
๐ฏ๐ตMatsumoto-shi, Nagano, Japan
University of the Ryukyus Hospital /ID# 252114
๐ฏ๐ตNakagami-gun, Okinawa, Japan
Dokkyo Medical University Saitama Medical Center /ID# 248731
๐ฏ๐ตKoshigaya, Saitama, Japan
The University of Tokyo Hospital /ID# 250194
๐ฏ๐ตBunkyo-ku, Tokyo, Japan
Chutoen General Medical Center /Id# 228780
๐ฏ๐ตKakegawa-shi, Shizuoka, Japan
Shizuoka Saiseikai Genaral Hospital /ID# 239088
๐ฏ๐ตShizuoka-shi, Shizuoka, Japan