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NCT04750213 Clinical Trial

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 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04750213
Other study ID # P20-251
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 12, 2021
Est. completion date August 31, 2025

Study information
Verified date June 2024
Source AbbVie
Contact AbbVie GK Clinical Trial Registration Desk
Phone +81-3-4577-1111
Email abbvie_jpn_info_clingov@abbvie.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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Study Design

Related Conditions & MeSH terms

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Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence Percentage of all the Infection Reported as Adverse Drug Reaction (ADR) 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. Up to 52 weeks
Secondary Incidence Percentage of Serious Infection Reported as ADR 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. Up to 52 weeks
Secondary Incidence Percentage of each ADR (Besides Infection) 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. Up to 52 weeks
Secondary Change in Physician's Global Assessment (PGA) [Global] Grade PGA will be used for overall assessment of efficacy. Up to Week 52
Secondary Change in PGA [Target] Grade PGA will be used for assessment of efficacy of target lesions. Up to Week 52
Secondary Change in Investigator Inflammation Assessment (IIA) Score from Start of Dosing IIA will be used for assessment of efficacy of target lesions. Up to Week 52
Secondary Change in Verbal Rating Scale (VRS) Category Pain improvement will be assessed using a VRS scale 0-3 with a lower score indicating less pain. Up to Week 52
Secondary Percentage of Participants with Recurrence Recurrence of PG. Up to Week 52
Secondary Time to Recurrence (Day) Recurrence of PG. Up to Week 52
Secondary Percentage of PG Subtype at Recurrence Recurrence of PG. PG subtypes include (ulcerative (including peristomal), bullous, pustular, vegetative). Up to Week 52
Secondary Pain Improvement Assessed with VRS Pain improvement will be assessed using a VRS scale 0-3 with a lower score indicating less pain. Week 26 to Week 52
See also
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Completed NCT00791557 - Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease N/A
Terminated NCT02318914 - A 2-Year, Open-Label, Safety Extension Study of Gevokizumab in Subjects With Pyoderma Gangrenosum Phase 3
Terminated NCT02315417 - An Efficacy and Safety Study of Gevokizumab in Treating Active Ulcers of Pyoderma Gangrenosum Phase 3
Completed NCT03137160 - An Open-Label, Proof-of-Concept Study of Ixekizumab in the Treatment of Pyoderma Gangrenosum Phase 2
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Not yet recruiting NCT04792957 - JAK-STAT Signaling Pathway in Pyoderma Gangrenosum
Not yet recruiting NCT05821374 - Deucravacitinib in PG Early Phase 1
Terminated NCT03072953 - Efficacy and Safety of APD334 in Patients With Pyoderma Gangrenosum Phase 2
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Withdrawn NCT00690846 - Study to Determine the Safety and Efficacy of Adalimumab in the Treatment of Pyoderma Gangrenosum Phase 2
Completed NCT01965613 - A Phase II Open Label Study of Xilonix in Subjects With Pyoderma Gangrenosum Phase 2
Recruiting NCT01952275 - Observational Study of the Genetic Architecture of Neutrophil-Mediated Inflammatory Skin Diseases N/A

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