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)

Last updated: June 17, 2024
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Skin Wounds

Pressure Ulcer

Treatment

N/A

Clinical Study ID

NCT04750213
P20-251
  • Ages > 15
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with Pyoderma Gangrenosum (PG).

  • Have been prescribed Humira for PG treatment within 14 days.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 60
Study Start date:
February 12, 2021
Estimated Completion Date:
August 31, 2025

Connect with a study center

  • Nagoya City University Hospital /ID# 233778

    Nagoya shi, Aichi 467-8602
    Japan

    Active - Recruiting

  • NHO Nagoya Medical Center /ID# 246013

    Nagoya-shi, Aichi 460-0001
    Japan

    Active - Recruiting

  • Akita University Hospital /ID# 242706

    Akita-shi, Akita 010-8543
    Japan

    Active - Recruiting

  • Japanese Red Cross Fukuoka Hospital /ID# 244051

    Fukuoka-shi, Fukuoka 815-8555
    Japan

    Active - Recruiting

  • Kyushu University Hospital /ID# 247492

    Fukuoka-shi, Fukuoka 812-8582
    Japan

    Active - Recruiting

  • Kurume University Hospital /ID# 246502

    Kurume-shi, Fukuoka 830-0011
    Japan

    Active - Recruiting

  • Central Japan International Medical Center /ID# 239391

    Minokamo-shi, Gifu 505-8510
    Japan

    Active - Recruiting

  • Gunma University Hospital /ID# 239390

    Maebashi-shi, Gunma 371-8511
    Japan

    Active - Recruiting

  • Hokkaido University Hospital /ID# 252567

    Sapporo-shi, Hokkaido 060-8648
    Japan

    Active - Recruiting

  • Sapporo Medical University Hospital /ID# 241180

    Sapporo-shi, Hokkaido 060-8543
    Japan

    Active - Recruiting

  • Kansai Rosai Hospital /ID# 246592

    Amagasaki-shi, Hyogo 660-8511
    Japan

    Active - Recruiting

  • Kobe University Hospital /ID# 249396

    Kobe, Hyogo 650-0017
    Japan

    Active - Recruiting

  • Kobe University Hospital /ID# 249396

    Kobe-shi, Hyogo 650-0017
    Japan

    Active - Recruiting

  • Nishi-Kobe Medical Center /ID# 244224

    Kobe-shi, Hyogo 651-2273
    Japan

    Completed

  • Ishikawa Prefectural Central Hospital /ID# 239089

    Kanazawa-shi, Ishikawa 920-8530
    Japan

    Active - Recruiting

  • Kanazawa University Hospital /ID# 248730

    Kanazawa-shi, Ishikawa 920-8641
    Japan

    Active - Recruiting

  • Kagawa Prefectural Central Hospital /ID# 250193

    Takamatsu-shi, Kagawa 760-0065
    Japan

    Active - Recruiting

  • Takamatsu Red Cross Hospital /ID# 240576

    Takamatsu-shi, Kagawa 760-0017
    Japan

    Active - Recruiting

  • Teikyo University Mizonokuchi Hospital /ID# 244693

    Kawasaki, Kanagawa 213-8507
    Japan

    Active - Recruiting

  • Teikyo University Hospital, Mizonokuchi /ID# 244693

    Kawasaki City, Kanagawa 213-0002
    Japan

    Site Not Available

  • Yokohama Minami Kyousai Hosp /ID# 252892

    Yokohama-shi, Kanagawa 236-0037
    Japan

    Active - Recruiting

  • Yokohama Municipal Citizen's Hospital /ID# 233779

    Yokohama-shi, Kanagawa 221-0855
    Japan

    Active - Recruiting

  • Kumamoto University Hospital /ID# 244050

    Kumamoto shi, Kumamoto 8608556
    Japan

    Active - Recruiting

  • Mie University Hospital /ID# 238747

    Tsu-shi, Mie 514-8507
    Japan

    Active - Recruiting

  • Tohoku Medical and Pharmaceuti /ID# 230270

    Sendai-shi, Miyagi 983-0005
    Japan

    Active - Recruiting

  • Tohoku University Hospital /ID# 252113

    Sendai-shi, Miyagi 9808574
    Japan

    Active - Recruiting

  • University of Miyazaki Hospital /ID# 241179

    Miyazaki-shi, Miyazaki 889-1692
    Japan

    Active - Recruiting

  • Shinshu University Hospital /ID# 230272

    Matsumoto-shi, Nagano 390-8621
    Japan

    Active - Recruiting

  • Nara Medical University Hospital /ID# 241880

    Kashihara-shi, Nara 634-8522
    Japan

    Active - Recruiting

  • Okayama University Hospital /ID# 238746

    Okayama-shi, Okayama 700-8558
    Japan

    Site Not Available

  • Naha City Hospital /ID# 240818

    Naha, Okinawa 902-0061
    Japan

    Active - Recruiting

  • Naha City Hospital /ID# 240818

    Naha-shi, Okinawa 902-8511
    Japan

    Site Not Available

  • University of the Ryukyus Hospital /ID# 252114

    Nakagami-gun, Okinawa 903-0215
    Japan

    Active - Recruiting

  • Okinawa Kyodo Hospital /ID# 241739

    那覇市, Okinawa 900-0024
    Japan

    Active - Recruiting

  • Kansai Medical University Hospital /ID# 228783

    Hirakata-shi, Osaka 573-1191
    Japan

    Active - Recruiting

  • Japanese Red Cross Osaka Hospital /ID# 228782

    Osaka-shi, Osaka 543-8555
    Japan

    Active - Recruiting

  • Kindai University Hospital /ID# 252568

    Osakasayama-shi, Osaka 589-8511
    Japan

    Active - Recruiting

  • Dokkyo Medical University Saitama Medical Center /ID# 248731

    Koshigaya, Saitama 343-0845
    Japan

    Active - Recruiting

  • Dokkyo Medical University Saitama Medical Center /ID# 248731

    Koshigaya-shi, Saitama 343-8555
    Japan

    Site Not Available

  • Hamamatsu University Hospital /ID# 240817

    Hamamatsu-shi, Shizuoka 431-3192
    Japan

    Active - Recruiting

  • Chutoen General Medical Center /Id# 228780

    Kakegawa-shi, Shizuoka 436-0040
    Japan

    Active - Recruiting

  • Shizuoka Saiseikai Genaral Hospital /ID# 239088

    Shizuoka-shi, Shizuoka 422-8527
    Japan

    Active - Recruiting

  • The University of Tokyo Hospital /ID# 250194

    Bunkyo-ku, Tokyo 113-8655
    Japan

    Active - Recruiting

  • Teikyo University Hospital /ID# 239389

    Itabashi-ku, Tokyo 173-8606
    Japan

    Site Not Available

  • The Jikei University Hospital /ID# 252112

    Minato-ku, Tokyo 105-8471
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital /ID# 233780

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Active - Recruiting

  • Yamanashi Kosei Hospital /ID# 242168

    Yamanashi City, Yamanashi 405-0033
    Japan

    Active - Recruiting

  • Fukuchiyama City Hospital /ID# 246593

    Fukuchiyama-shi, 620-8505
    Japan

    Active - Recruiting

  • Okayama University Hospital /ID# 238746

    Okayama, 700-8558
    Japan

    Active - Recruiting

  • Takatsuki General Hospital /ID# 244694

    Osaka,
    Japan

    Active - Recruiting

  • Hokkaido Medical Center /ID# 251657

    Sapporo-shi, 063-0005
    Japan

    Active - Recruiting

  • Teikyo University /ID# 239389

    Tokyo, 173-8605
    Japan

    Active - Recruiting

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