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)

Pyoderma Gangrenosum Clinical Trial

Official title:

Post-marketing Observational Study for Humira in Participants Diagnosed With Pyoderma Gangrenosum (PG)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04750213
• Other study ID #: P20-251
• Status: Recruiting
• Start date: February 12, 2021
• Est. completion date: August 31, 2025

Study information

• Verified date: January 2023
• Source: AbbVie
• Contact: AbbVie GK Clinical Trial Registration Desk
• Phone: +81-3-4577-1111
• Email: abbvie_jpn_info_clingov[@]abbvie.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed with Pyoderma Gangrenosum (PG).
• Have been prescribed Humira for PG treatment within 14 days.

Exclusion Criteria:

• Have Pyoderma Gangrenosum (PG) in previous treatment with Humira.

Related Conditions & MeSH terms

• Pyoderma
• Pyoderma Gangrenosum

Locations

Country	Name	City	State
Japan	Okinawa Kyodo Hospital /ID# 241739	???	Okinawa
Japan	Akita University Hospital /ID# 242706	Akita-shi	Akita
Japan	Kansai Rosai Hospital /ID# 246592	Amagasaki-shi	Hyogo
Japan	The University of Tokyo Hospital /ID# 250194	Bunkyo-ku	Tokyo
Japan	Fukuchiyama City Hospital /ID# 246593	Fukuchiyama-shi
Japan	Japanese Red Cross Fukuoka Hospital /ID# 244051	Fukuoka-shi	Fukuoka
Japan	Kyushu University Hospital /ID# 247492	Fukuoka-shi	Fukuoka
Japan	Hamamatsu University Hospital /ID# 240817	Hamamatsu-shi	Shizuoka
Japan	Kansai Medical University Hospital /ID# 228783	Hirakata-shi	Osaka
Japan	Teikyo University Hospital /ID# 239389	Itabashi-ku	Tokyo
Japan	Chutoen General Medical Center /ID# 228780	Kakegawa-shi	Shizuoka
Japan	Ishikawa Prefectural Central Hospital /ID# 239089	Kanazawa-shi	Ishikawa
Japan	Kanazawa University Hospital /ID# 248730	Kanazawa-shi	Ishikawa
Japan	Nara Medical University Hospital /ID# 241880	Kashihara-shi	Nara
Japan	Teikyo University Hospital, Mizonokuchi /ID# 244693	Kawasaki City	Kanagawa
Japan	Kobe University Hospital /ID# 249396	Kobe-shi	Hyogo
Japan	Nishi-Kobe Medical Center /ID# 244224	Kobe-shi	Hyogo
Japan	Dokkyo Medical University Saitama Medical Center /ID# 248731	Koshigaya-shi	Saitama
Japan	Kumamoto University Hospital /ID# 244050	Kumamoto shi	Kumamoto
Japan	Kurume University Hospital /ID# 246502	Kurume-shi	Fukuoka
Japan	Gunma University Hospital /ID# 239390	Maebashi-shi	Gunma
Japan	Shinshu University Hospital /ID# 230272	Matsumoto-shi	Nagano
Japan	The Jikei University Hospital /ID# 252112	Minato-ku	Tokyo
Japan	Central Japan International Medical Center /ID# 239391	Minokamo-shi	Gifu
Japan	University of Miyazaki Hospital /ID# 241179	Miyazaki-shi	Miyazaki
Japan	Nagoya City University Hospital /ID# 233778	Nagoya shi	Aichi
Japan	NHO Nagoya Medical Center /ID# 246013	Nagoya-shi	Aichi
Japan	Naha City Hospital /ID# 240818	Naha-shi	Okinawa
Japan	University of the Ryukyus Hospital /ID# 252114	Nakagami-gun	Okinawa
Japan	Okayama University Hospital /ID# 238746	Okayama-shi	Okayama
Japan	Takatsuki General Hospital /ID# 244694	Osaka
Japan	Japanese Red Cross Osaka Hospital /ID# 228782	Osaka-shi	Osaka
Japan	Kindai University Hospital /ID# 252568	Osakasayama-shi	Osaka
Japan	Hokkaido Medical Center /ID# 251657	Sapporo-shi
Japan	Hokkaido University Hospital /ID# 252567	Sapporo-shi	Hokkaido
Japan	Sapporo Medical University Hospital /ID# 241180	Sapporo-shi	Hokkaido
Japan	Tohoku Medical and Pharmaceuti /ID# 230270	Sendai-shi	Miyagi
Japan	Tohoku University Hospital /ID# 252113	Sendai-shi	Miyagi
Japan	Tokyo Medical University Hospital /ID# 233780	Shinjuku-ku	Tokyo
Japan	Shizuoka Saiseikai Genaral Hospital /ID# 239088	Shizuoka-shi	Shizuoka
Japan	Kagawa Prefectural Central Hospital /ID# 250193	Takamatsu-shi	Kagawa
Japan	Takamatsu Red Cross Hospital /ID# 240576	Takamatsu-shi	Kagawa
Japan	Mie University Hospital /ID# 238747	Tsu-shi	Mie
Japan	Yamanashi Kosei Hospital /ID# 242168	Yamanashi City	Yamanashi
Japan	Yokohama Municipal Citizen's Hospital /ID# 233779	Yokohama-shi	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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
Secondary	Change in Physician's Global Assessment (PGA) [Global] Grade	PGA will be used for overall assessment of efficacy.	Up to Week 52
Secondary	Change in PGA [Target] Grade	PGA will be used for assessment of efficacy of target lesions.	Up to Week 52
Secondary	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
Secondary	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
Secondary	Percentage of Participants with Recurrence	Recurrence of PG.	Up to Week 52
Secondary	Time to Recurrence (Day)	Recurrence of PG.	Up to Week 52
Secondary	Percentage of PG Subtype at Recurrence	Recurrence of PG. PG subtypes include (ulcerative (including peristomal), bullous, pustular, vegetative).	Up to Week 52
Secondary	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

External Links

•   This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.