NCT04750213

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)

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2021-02-12
• Primary completion: 2024-11-11
• Completion: 2024-11-11
• First posted: 2021-02-11
• Last updated: 2025-07-17

Locations

46 sites across 1 country: Japan