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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)

NCT04750213 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-07-17

No results posted yet for this 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.

Conditions

  • Pyoderma Gangrenosum

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-12
Primary Completion
2024-11-11
Completion
2024-11-11

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04750213 on ClinicalTrials.gov