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)

Study Identifier
P20-251
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete

Study Details

Medical Condition
  • Dermatology - Other
  • Study Drug
    N/A
    Phase
    N/A
    Sex
    Female & Male
    Age
    15+ years

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    NHO Nagoya Medical Center /ID# 246013
    Nagoya, Aichi-ken, Japan, 460-0001
    Status
    Not applicable
    Location
    Nagoya City University Hospital /ID# 233778
    Nagoya, Aichi-ken, Japan, 467-8602
    Status
    Not applicable
    Location
    Akita University Hospital /ID# 242706
    Akita, Akita, Japan, 010-8543
    Status
    Not applicable
    Location
    Kyushu University Hospital /ID# 247492
    Fukuoka, Fukuoka, Japan, 812-8582
    Status
    Not applicable
    Location
    Japanese Red Cross Fukuoka Hospital /ID# 244051
    Fukuoka, Fukuoka, Japan, 815-8555
    Status
    Not applicable
    Location
    Kurume University Hospital /ID# 246502
    Kurume-shi, Fukuoka, Japan, 830-0011
    Status
    Not applicable
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