Skip to main content
OpenTrials
Completed

NCT Number: 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)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pyoderma Gangrenosum Pyoderma Skin Diseases Skin Diseases, Vascular Skin Ulcer Skin and Connective Tissue Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NHO Nagoya Medical Center /ID# 246013, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence Percentage of all the Infection Reported as Adverse Drug Reaction (ADR)

    Time frame: Up to 52 weeks

    An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.

Secondary outcomes

  1. Incidence Percentage of Serious Infection Reported as ADR

    Time frame: Up to 52 weeks

    An AE is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.

  2. Incidence Percentage of each ADR (Besides Infection)

    Time frame: Up to 52 weeks

    An AE is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction.

  3. Change in Physician's Global Assessment (PGA) [Global] Grade

    Time frame: Up to Week 52

    PGA will be used for overall assessment of efficacy.

  4. Change in PGA [Target] Grade

    Time frame: Up to Week 52

    PGA will be used for assessment of efficacy of target lesions.

  5. Change in Investigator Inflammation Assessment (IIA) Score from Start of Dosing

    Time frame: Up to Week 52

    IIA will be used for assessment of efficacy of target lesions.

  6. Change in Verbal Rating Scale (VRS) Category

    Time frame: Up to Week 52

    Pain improvement will be assessed using a VRS scale 0-3 with a lower score indicating less pain.

  7. Percentage of Participants with Recurrence

    Time frame: Up to Week 52

    Recurrence of PG.

  8. Time to Recurrence (Day)

    Time frame: Up to Week 52

    Recurrence of PG.

  9. Percentage of PG Subtype at Recurrence

    Time frame: Up to Week 52

    Recurrence of PG. PG subtypes include (ulcerative (including peristomal), bullous, pustular, vegetative).

  10. Pain Improvement Assessed with VRS

    Time frame: Week 26 to Week 52

    Pain improvement will be assessed using a VRS scale 0-3 with a lower score indicating less pain.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Feb 11, 2021
Registry last updated
Jul 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.