Clinical trial 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)
Official title: Post-marketing Observational Study for Humira in Participants Diagnosed With Pyoderma Gangrenosum (PG)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pyoderma Gangrenosum
Keywords: Pyoderma Gangrenosum
Humira
Adalimumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-02-11
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence Percentage of all the Infection Reported as Adverse Drug Reaction (ADR)
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Incidence Percentage of Serious Infection Reported as ADR
timeFrame: Up to 52 weeks
measure: Incidence Percentage of each ADR (Besides Infection)
timeFrame: Up to 52 weeks
measure: Change in Physician's Global Assessment (PGA) [Global] Grade
timeFrame: Up to Week 52
measure: Change in PGA [Target] Grade
timeFrame: Up to Week 52
measure: Change in Investigator Inflammation Assessment (IIA) Score from Start of Dosing
timeFrame: Up to Week 52
measure: Change in Verbal Rating Scale (VRS) Category
timeFrame: Up to Week 52
measure: Percentage of Participants with Recurrence
timeFrame: Up to Week 52
measure: Time to Recurrence (Day)
timeFrame: Up to Week 52
measure: Percentage of PG Subtype at Recurrence
timeFrame: Up to Week 52
measure: Pain Improvement Assessed with VRS
timeFrame: Week 26 to Week 52
Other outcomes:
Locations:
city: Nagoya shi
country: Japan
facility: Nagoya City University Hospital /ID# 233778
state: Aichi
city: Nagoya-shi
country: Japan
facility: NHO Nagoya Medical Center /ID# 246013
state: Aichi
city: Akita-shi
country: Japan
facility: Akita University Hospital /ID# 242706
state: Akita
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 247492
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Japanese Red Cross Fukuoka Hospital /ID# 244051
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital /ID# 246502
state: Fukuoka
city: Minokamo-shi
country: Japan
facility: Central Japan International Medical Center /ID# 239391
state: Gifu
city: Maebashi-shi
country: Japan
facility: Gunma University Hospital /ID# 239390
state: Gunma
city: Sapporo-shi
country: Japan
facility: Sapporo Medical University Hospital /ID# 241180
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital /ID# 252567
state: Hokkaido
city: Amagasaki-shi
country: Japan
facility: Kansai Rosai Hospital /ID# 246592
state: Hyogo
city: Kobe-shi
country: Japan
facility: Nishi-Kobe Medical Center /ID# 244224
state: Hyogo
city: Kobe
country: Japan
facility: Kobe University Hospital /ID# 249396
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Ishikawa Prefectural Central Hospital /ID# 239089
state: Ishikawa
city: Kanazawa-shi
country: Japan
facility: Kanazawa University Hospital /ID# 248730
state: Ishikawa
city: Takamatsu-shi
country: Japan
facility: Takamatsu Red Cross Hospital /ID# 240576
state: Kagawa
city: Takamatsu-shi
country: Japan
facility: Kagawa Prefectural Central Hospital /ID# 250193
state: Kagawa
city: Kawasaki
country: Japan
facility: Teikyo University Mizonokuchi Hospital /ID# 244693
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama Municipal Citizen's Hospital /ID# 233779
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama Minami Kyousai Hosp /ID# 252892
state: Kanagawa
city: Kumamoto shi
country: Japan
facility: Kumamoto University Hospital /ID# 244050
state: Kumamoto
city: Tsu-shi
country: Japan
facility: Mie University Hospital /ID# 238747
state: Mie
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital /ID# 252113
state: Miyagi
city: Sendai-shi
country: Japan
facility: Tohoku Medical and Pharmaceuti /ID# 230270
state: Miyagi
city: Miyazaki-shi
country: Japan
facility: University of Miyazaki Hospital /ID# 241179
state: Miyazaki
city: Matsumoto-shi
country: Japan
facility: Shinshu University Hospital /ID# 230272
state: Nagano
city: Kashihara-shi
country: Japan
facility: Nara Medical University Hospital /ID# 241880
state: Nara
city: Naha
country: Japan
facility: Naha City Hospital /ID# 240818
state: Okinawa
city: Nakagami-gun
country: Japan
facility: University of the Ryukyus Hospital /ID# 252114
state: Okinawa
city: 那覇市
country: Japan
facility: Okinawa Kyodo Hospital /ID# 241739
state: Okinawa
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital /ID# 228783
state: Osaka
city: Osaka-shi
country: Japan
facility: Japanese Red Cross Osaka Hospital /ID# 228782
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital /ID# 252568
state: Osaka
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center /ID# 248731
state: Saitama
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University Hospital /ID# 240817
state: Shizuoka
city: Kakegawa-shi
country: Japan
facility: Chutoen General Medical Center /Id# 228780
state: Shizuoka
city: Shizuoka-shi
country: Japan
facility: Shizuoka Saiseikai Genaral Hospital /ID# 239088
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital /ID# 250194
state: Tokyo
city: Minato-ku
country: Japan
facility: The Jikei University Hospital /ID# 252112
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 233780
state: Tokyo
city: Yamanashi City
country: Japan
facility: Yamanashi Kosei Hospital /ID# 242168
state: Yamanashi
city: Fukuchiyama-shi
country: Japan
facility: Fukuchiyama City Hospital /ID# 246593
city: Okayama
country: Japan
facility: Okayama University Hospital /ID# 238746
city: Osaka
country: Japan
facility: Takatsuki General Hospital /ID# 244694
city: Sapporo-shi
country: Japan
facility: Hokkaido Medical Center /ID# 251657
city: Tokyo
country: Japan
facility: Teikyo University /ID# 239389
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: