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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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date August 31, 2025
Est. primary completion date August 31, 2025
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Japan Okinawa Kyodo Hospital /ID# 241739 ??? Okinawa
Japan Akita University Hospital /ID# 242706 Akita-shi Akita
Japan Kansai Rosai Hospital /ID# 246592 Amagasaki-shi Hyogo
Japan The University of Tokyo Hospital /ID# 250194 Bunkyo-ku Tokyo
Japan Fukuchiyama City Hospital /ID# 246593 Fukuchiyama-shi
Japan Japanese Red Cross Fukuoka Hospital /ID# 244051 Fukuoka-shi Fukuoka
Japan Kyushu University Hospital /ID# 247492 Fukuoka-shi Fukuoka
Japan Hamamatsu University Hospital /ID# 240817 Hamamatsu-shi Shizuoka
Japan Kansai Medical University Hospital /ID# 228783 Hirakata-shi Osaka
Japan Chutoen General Medical Center /Id# 228780 Kakegawa-shi Shizuoka
Japan Ishikawa Prefectural Central Hospital /ID# 239089 Kanazawa-shi Ishikawa
Japan Kanazawa University Hospital /ID# 248730 Kanazawa-shi Ishikawa
Japan Nara Medical University Hospital /ID# 241880 Kashihara-shi Nara
Japan Teikyo University Mizonokuchi Hospital /ID# 244693 Kawasaki Kanagawa
Japan Kobe University Hospital /ID# 249396 Kobe Hyogo
Japan Nishi-Kobe Medical Center /ID# 244224 Kobe-shi Hyogo
Japan Dokkyo Medical University Saitama Medical Center /ID# 248731 Koshigaya Saitama
Japan Kumamoto University Hospital /ID# 244050 Kumamoto shi Kumamoto
Japan Kurume University Hospital /ID# 246502 Kurume-shi Fukuoka
Japan Gunma University Hospital /ID# 239390 Maebashi-shi Gunma
Japan Shinshu University Hospital /ID# 230272 Matsumoto-shi Nagano
Japan The Jikei University Hospital /ID# 252112 Minato-ku Tokyo
Japan Central Japan International Medical Center /ID# 239391 Minokamo-shi Gifu
Japan University of Miyazaki Hospital /ID# 241179 Miyazaki-shi Miyazaki
Japan Nagoya City University Hospital /ID# 233778 Nagoya shi Aichi
Japan NHO Nagoya Medical Center /ID# 246013 Nagoya-shi Aichi
Japan Naha City Hospital /ID# 240818 Naha Okinawa
Japan University of the Ryukyus Hospital /ID# 252114 Nakagami-gun Okinawa
Japan Okayama University Hospital /ID# 238746 Okayama
Japan Takatsuki General Hospital /ID# 244694 Osaka
Japan Japanese Red Cross Osaka Hospital /ID# 228782 Osaka-shi Osaka
Japan Kindai University Hospital /ID# 252568 Osakasayama-shi Osaka
Japan Hokkaido Medical Center /ID# 251657 Sapporo-shi
Japan Hokkaido University Hospital /ID# 252567 Sapporo-shi Hokkaido
Japan Sapporo Medical University Hospital /ID# 241180 Sapporo-shi Hokkaido
Japan Tohoku Medical and Pharmaceuti /ID# 230270 Sendai-shi Miyagi
Japan Tohoku University Hospital /ID# 252113 Sendai-shi Miyagi
Japan Tokyo Medical University Hospital /ID# 233780 Shinjuku-ku Tokyo
Japan Shizuoka Saiseikai Genaral Hospital /ID# 239088 Shizuoka-shi Shizuoka
Japan Kagawa Prefectural Central Hospital /ID# 250193 Takamatsu-shi Kagawa
Japan Takamatsu Red Cross Hospital /ID# 240576 Takamatsu-shi Kagawa
Japan Teikyo University /ID# 239389 Tokyo
Japan Mie University Hospital /ID# 238747 Tsu-shi Mie
Japan Yamanashi Kosei Hospital /ID# 242168 Yamanashi City Yamanashi
Japan Yokohama Minami Kyousai Hosp /ID# 252892 Yokohama-shi Kanagawa
Japan Yokohama Municipal Citizen's Hospital /ID# 233779 Yokohama-shi Kanagawa

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
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