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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Receiving Humira (Adalimumab) | Participants receiving Adalimumab for Pyoderma Gangrenosum (PG). |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
- Have Pyoderma Gangrenosum (PG) in previous treatment with Humira.
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Patients
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NHO Nagoya Medical Center /ID# 246013 | Nagoya | Aichi-ken | 460-0001 | Japan | ||
| Nagoya City University Hospital /ID# 233778 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42107018 | Derived | Yamamoto T, Tanizaki H, Yamasaki K, Matsubara N, Nakayama M, Iwashita E, Yamanaka K. Safety and Effectiveness of Adalimumab for the Treatment of Pyoderma Gangrenosum: A 52-Week Real-World Prospective Observational Study. Dermatol Ther (Heidelb). 2026 Jun;16(6):3167-3188. doi: 10.1007/s13555-026-01772-4. Epub 2026 May 10. |
| Label | URL |
|---|---|
| This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses. | View source |
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| 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 |
| Nagoya |
| Aichi-ken |
| 467-8602 |
| Japan |
| Akita University Hospital /ID# 242706 | Akita | Akita | 010-8543 | Japan |
| Kyushu University Hospital /ID# 247492 | Fukuoka | Fukuoka | 812-8582 | Japan |
| Japanese Red Cross Fukuoka Hospital /ID# 244051 | Fukuoka | Fukuoka | 815-8555 | Japan |
| Kurume University Hospital /ID# 246502 | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Central Japan International Medical Center /ID# 239391 | Minokamo-shi | Gifu | 505-8510 | Japan |
| Gunma University Hospital /ID# 239390 | Maebashi | Gunma | 371-8511 | Japan |
| Sapporo Medical University Hospital /ID# 241180 | Sapporo | Hokkaido | 060-8543 | Japan |
| Hokkaido University Hospital /ID# 252567 | Sapporo | Hokkaido | 060-8648 | Japan |
| Hokkaido Medical Center /ID# 251657 | Sapporo | Hokkaido | 063-0005 | Japan |
| Kansai Rosai Hospital /ID# 246592 | Amagasaki-shi | Hyōgo | 660-8511 | Japan |
| Kobe University Hospital /ID# 249396 | Kobe | Hyōgo | 650-0017 | Japan |
| Nishi-Kobe Medical Center /ID# 244224 | Kobe | Hyōgo | 651-2273 | Japan |
| Ishikawa Prefectural Central Hospital /ID# 239089 | Kanazawa | Ishikawa-ken | 920-8530 | Japan |
| Kanazawa University Hospital /ID# 248730 | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Takamatsu Red Cross Hospital /ID# 240576 | Takamatsu | Kagawa-ken | 760-0017 | Japan |
| Kagawa Prefectural Central Hospital /ID# 250193 | Takamatsu | Kagawa-ken | 760-0065 | Japan |
| Teikyo University Mizonokuchi Hospital /ID# 244693 | Kawasaki | Kanagawa | 213-8507 | Japan |
| Yokohama Municipal Citizen's Hospital /ID# 233779 | Yokohama | Kanagawa | 221-0855 | Japan |
| Yokohama Minami Kyousai Hosp /ID# 252892 | Yokohama | Kanagawa | 236-0037 | Japan |
| Kumamoto University Hospital /ID# 244050 | Kumamoto | Kumamoto | 8608556 | Japan |
| Fukuchiyama City Hospital /ID# 246593 | Fukuchiyama-shi | Kyoto | 620-8505 | Japan |
| Mie University Hospital /ID# 238747 | Tsu | Mie-ken | 514-8507 | Japan |
| Tohoku University Hospital /ID# 252113 | Sendai | Miyagi | 9808574 | Japan |
| Tohoku Medical and Pharmaceuti /ID# 230270 | Sendai | Miyagi | 983-0005 | Japan |
| University of Miyazaki Hospital /ID# 241179 | Miyazaki | Miyazaki | 889-1692 | Japan |
| Shinshu University Hospital /ID# 230272 | Matsumoto-shi | Nagano | 390-8621 | Japan |
| Nara Medical University Hospital /ID# 241880 | Kashihara-shi | Nara | 634-8522 | Japan |
| Okayama University Hospital /ID# 238746 | Okayama | Okayama-ken | 700-8558 | Japan |
| Okinawa Kyodo Hospital /ID# 241739 | Naha | Okinawa | 900-0024 | Japan |
| Naha City Hospital /ID# 240818 | Naha | Okinawa | 902-0061 | Japan |
| University of the Ryukyus Hospital /ID# 252114 | Nakagami-gun | Okinawa | 903-0215 | Japan |
| Kansai Medical University Hospital /ID# 228783 | Hirakata-shi | Osaka | 573-1191 | Japan |
| Japanese Red Cross Osaka Hospital /ID# 228782 | Osaka | Osaka | 543-8555 | Japan |
| Kindai University Hospital /ID# 252568 | Osakasayama-shi | Osaka | 589-8511 | Japan |
| Dokkyo Medical University Saitama Medical Center /ID# 248731 | Koshigaya | Saitama | 343-0845 | Japan |
| Hamamatsu University Hospital /ID# 240817 | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Chutoen General Medical Center /Id# 228780 | Kakegawa-shi | Shizuoka | 436-0040 | Japan |
| Shizuoka Saiseikai Genaral Hospital /ID# 239088 | Shizuoka | Shizuoka | 422-8527 | Japan |
| The University of Tokyo Hospital /ID# 250194 | Bunkyo-ku | Tokyo | 113-8655 | Japan |
| The Jikei University Hospital /ID# 252112 | Minato-ku | Tokyo | 105-8471 | Japan |
| Tokyo Medical University Hospital /ID# 233780 | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Yamanashi Kosei Hospital /ID# 242168 | Yamanashi | Yamanashi | 405-0033 | Japan |
| Takatsuki General Hospital /ID# 244694 | Osaka | Japan |
| Teikyo University Hospital /ID# 239389 | Tokyo | 173-8605 | Japan |
| ID | Term |
|---|---|
| D017511 | Pyoderma Gangrenosum |
| ID | Term |
|---|---|
| D011711 | Pyoderma |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |
| D012883 | Skin Ulcer |
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