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)

NCT ID: NCT04750213

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-02-12
• Study Completion Date: 2024-11-11

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.

Conditions

Pyoderma Gangrenosum

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants Receiving Humira (Adalimumab)

Participants receiving Adalimumab for Pyoderma Gangrenosum (PG).

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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

Hokkaido Medical Center /ID# 251657

Sapporo, Hokkaido, Japan

Kansai Rosai Hospital /ID# 246592

Amagasaki-shi, Hyōgo, Japan

Kobe University Hospital /ID# 249396

Kobe, Hyōgo, Japan

Nishi-Kobe Medical Center /ID# 244224

Kobe, Hyōgo, Japan

Ishikawa Prefectural Central Hospital /ID# 239089

Kanazawa, Ishikawa-ken, Japan

Kanazawa University Hospital /ID# 248730

Kanazawa, Ishikawa-ken, Japan

Takamatsu Red Cross Hospital /ID# 240576

Takamatsu, Kagawa-ken, Japan

Kagawa Prefectural Central Hospital /ID# 250193

Takamatsu, Kagawa-ken, Japan

Teikyo University Mizonokuchi Hospital /ID# 244693

Kawasaki, Kanagawa, Japan

Yokohama Municipal Citizen's Hospital /ID# 233779

Yokohama, Kanagawa, Japan

Yokohama Minami Kyousai Hosp /ID# 252892

Yokohama, Kanagawa, Japan

Kumamoto University Hospital /ID# 244050

Kumamoto, Kumamoto, Japan

Fukuchiyama City Hospital /ID# 246593

Fukuchiyama-shi, Kyoto, Japan

Mie University Hospital /ID# 238747

Tsu, Mie-ken, Japan

Tohoku University Hospital /ID# 252113

Sendai, Miyagi, Japan

Tohoku Medical and Pharmaceuti /ID# 230270

Sendai, Miyagi, Japan

University of Miyazaki Hospital /ID# 241179

Miyazaki, Miyazaki, Japan

Shinshu University Hospital /ID# 230272

Matsumoto-shi, Nagano, Japan

Nara Medical University Hospital /ID# 241880

Kashihara-shi, Nara, Japan

Okayama University Hospital /ID# 238746

Okayama, Okayama-ken, Japan

Okinawa Kyodo Hospital /ID# 241739

Naha, Okinawa, Japan

Naha City Hospital /ID# 240818

Naha, Okinawa, Japan

University of the Ryukyus Hospital /ID# 252114

Nakagami-gun, Okinawa, Japan

Kansai Medical University Hospital /ID# 228783

Hirakata-shi, Osaka, Japan

Japanese Red Cross Osaka Hospital /ID# 228782

Osaka, Osaka, Japan

Kindai University Hospital /ID# 252568

Osakasayama-shi, Osaka, Japan

Dokkyo Medical University Saitama Medical Center /ID# 248731

Koshigaya, Saitama, Japan

Hamamatsu University Hospital /ID# 240817

Hamamatsu, Shizuoka, Japan

Chutoen General Medical Center /Id# 228780

Kakegawa-shi, Shizuoka, Japan

Shizuoka Saiseikai Genaral Hospital /ID# 239088

Shizuoka, Shizuoka, Japan

The University of Tokyo Hospital /ID# 250194

Bunkyo-ku, Tokyo, Japan

The Jikei University Hospital /ID# 252112

Minato-ku, Tokyo, Japan

Tokyo Medical University Hospital /ID# 233780

Shinjuku-ku, Tokyo, Japan

Yamanashi Kosei Hospital /ID# 242168

Yamanashi, Yamanashi, Japan

Takatsuki General Hospital /ID# 244694

Osaka, , Japan

Teikyo University Hospital /ID# 239389

Tokyo, , Japan

Countries

Japan

Related Links

https://www.rxabbvie.com

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

Other Identifiers

P20-251

Identifier Type: -

Identifier Source: org_study_id