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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)

Recruiting
15 years of age
Both
Phase N/A

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Overview

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

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.

Study details

Pyoderma Gangrenosum

NCT04750213

AbbVie

22 June 2024

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