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)

January 13, 2023 updated by: AbbVie

Post-marketing Observational Study for 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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Fukuchiyama-shi, Japan, 620-8505
        • Recruiting
        • Fukuchiyama City Hospital /ID# 246593
      • Osaka, Japan
        • Recruiting
        • Takatsuki General Hospital /ID# 244694
      • Sapporo-shi, Japan, 063-0005
        • Recruiting
        • Hokkaido Medical Center /ID# 251657
    • Aichi
      • Nagoya shi, Aichi, Japan, 467-8602
        • Recruiting
        • Nagoya City University Hospital /ID# 233778
      • Nagoya-shi, Aichi, Japan, 460-0001
        • Recruiting
        • NHO Nagoya Medical Center /ID# 246013
    • Akita
      • Akita-shi, Akita, Japan, 010-8543
        • Recruiting
        • Akita University Hospital /ID# 242706
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital /ID# 247492
      • Fukuoka-shi, Fukuoka, Japan, 815-8555
        • Recruiting
        • Japanese Red Cross Fukuoka Hospital /ID# 244051
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital /ID# 246502
    • Gifu
      • Minokamo-shi, Gifu, Japan, 505-8510
        • Recruiting
        • Central Japan International Medical Center /ID# 239391
    • Gunma
      • Maebashi-shi, Gunma, Japan, 371-8511
        • Recruiting
        • Gunma University Hospital /ID# 239390
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 060-8543
        • Recruiting
        • Sapporo Medical University Hospital /ID# 241180
      • Sapporo-shi, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital /ID# 252567
    • Hyogo
      • Amagasaki-shi, Hyogo, Japan, 660-8511
        • Recruiting
        • Kansai Rosai Hospital /ID# 246592
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Recruiting
        • Kobe University Hospital /ID# 249396
      • Kobe-shi, Hyogo, Japan, 651-2273
        • Completed
        • Nishi-Kobe Medical Center /ID# 244224
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 920-8530
        • Recruiting
        • Ishikawa Prefectural Central Hospital /ID# 239089
      • Kanazawa-shi, Ishikawa, Japan, 920-8641
        • Recruiting
        • Kanazawa University Hospital /ID# 248730
    • Kagawa
      • Takamatsu-shi, Kagawa, Japan, 760-0017
        • Recruiting
        • Takamatsu Red Cross Hospital /ID# 240576
      • Takamatsu-shi, Kagawa, Japan, 760-0065
        • Recruiting
        • Kagawa Prefectural Central Hospital /ID# 250193
    • Kanagawa
      • Kawasaki City, Kanagawa, Japan, 213-0002
        • Recruiting
        • Teikyo University Hospital, Mizonokuchi /ID# 244693
      • Yokohama-shi, Kanagawa, Japan, 221-0855
        • Recruiting
        • Yokohama Municipal Citizen's Hospital /ID# 233779
    • Kumamoto
      • Kumamoto shi, Kumamoto, Japan, 8608556
        • Recruiting
        • Kumamoto University Hospital /ID# 244050
    • Mie
      • Tsu-shi, Mie, Japan, 514-8507
        • Recruiting
        • Mie University Hospital /ID# 238747
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 9808574
        • Recruiting
        • Tohoku University Hospital /ID# 252113
      • Sendai-shi, Miyagi, Japan, 983-0005
        • Recruiting
        • Tohoku Medical and Pharmaceuti /ID# 230270
    • Miyazaki
      • Miyazaki-shi, Miyazaki, Japan, 889-1692
        • Recruiting
        • University of Miyazaki Hospital /ID# 241179
    • Nagano
      • Matsumoto-shi, Nagano, Japan, 390-8621
        • Recruiting
        • Shinshu University Hospital /ID# 230272
    • Nara
      • Kashihara-shi, Nara, Japan, 634-8522
        • Recruiting
        • Nara Medical University Hospital /ID# 241880
    • Okayama
      • Okayama-shi, Okayama, Japan, 700-8558
        • Recruiting
        • Okayama University Hospital /ID# 238746
    • Okinawa
      • Naha-shi, Okinawa, Japan, 902-8511
        • Recruiting
        • Naha City Hospital /ID# 240818
      • Nakagami-gun, Okinawa, Japan, 903-0215
        • Recruiting
        • University of the Ryukyus Hospital /ID# 252114
      • 那覇市, Okinawa, Japan, 900-0024
        • Recruiting
        • Okinawa Kyodo Hospital /ID# 241739
    • Osaka
      • Hirakata-shi, Osaka, Japan, 573-1191
        • Recruiting
        • Kansai Medical University Hospital /ID# 228783
      • Osaka-shi, Osaka, Japan, 543-8555
        • Recruiting
        • Japanese Red Cross Osaka Hospital /ID# 228782
      • Osakasayama-shi, Osaka, Japan, 589-8511
        • Recruiting
        • Kindai University Hospital /ID# 252568
    • Saitama
      • Koshigaya-shi, Saitama, Japan, 343-8555
        • Recruiting
        • Dokkyo Medical University Saitama Medical Center /ID# 248731
    • Shizuoka
      • Hamamatsu-shi, Shizuoka, Japan, 431-3192
        • Recruiting
        • Hamamatsu University Hospital /ID# 240817
      • Kakegawa-shi, Shizuoka, Japan, 436-0040
        • Recruiting
        • Chutoen General Medical Center /ID# 228780
      • Shizuoka-shi, Shizuoka, Japan, 422-8527
        • Recruiting
        • Shizuoka Saiseikai Genaral Hospital /ID# 239088
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8655
        • Recruiting
        • The University of Tokyo Hospital /ID# 250194
      • Itabashi-ku, Tokyo, Japan, 173-8606
        • Recruiting
        • Teikyo University Hospital /ID# 239389
      • Minato-ku, Tokyo, Japan, 105-8471
        • Recruiting
        • The Jikei University Hospital /ID# 252112
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital /ID# 233780
    • Yamanashi
      • Yamanashi City, Yamanashi, Japan, 405-0033
        • Recruiting
        • Yamanashi Kosei Hospital /ID# 242168

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Participants Receiving Humira (Adalimumab)
Participants receiving Adalimumab for Pyoderma Gangrenosum (PG).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 52 weeks
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.
Up to 52 weeks
Change in Physician's Global Assessment (PGA) [Global] Grade
Time Frame: Up to Week 52
PGA will be used for overall assessment of efficacy.
Up to Week 52
Change in PGA [Target] Grade
Time Frame: Up to Week 52
PGA will be used for assessment of efficacy of target lesions.
Up to Week 52
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.
Up to Week 52
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.
Up to Week 52
Percentage of Participants with Recurrence
Time Frame: Up to Week 52
Recurrence of PG.
Up to Week 52
Time to Recurrence (Day)
Time Frame: Up to Week 52
Recurrence of PG.
Up to Week 52
Percentage of PG Subtype at Recurrence
Time Frame: Up to Week 52
Recurrence of PG. PG subtypes include (ulcerative (including peristomal), bullous, pustular, vegetative).
Up to Week 52
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.
Week 26 to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2021

Primary Completion (Anticipated)

August 31, 2025

Study Completion (Anticipated)

August 31, 2025

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 10, 2021

First Posted (Actual)

February 11, 2021

Study Record Updates

Last Update Posted (Estimate)

January 16, 2023

Last Update Submitted That Met QC Criteria

January 13, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P20-251

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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