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)

NCT04750213 | Completed

• 1 other identifier: P20-251
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 46

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.

Conditions

Pyoderma Gangrenosum

Keywords

Pyoderma Gangrenosum; Humira; Adalimumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Incidence Percentage of Serious Infection Reported as ADR

  Up to 52 weeks

• Incidence Percentage of each ADR (Besides Infection)

  Up to 52 weeks

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

  Up to Week 52

• Change in PGA [Target] Grade

  Up to Week 52

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

  Up to Week 52

Study Arms (1)

Participants Receiving Humira (Adalimumab)

Participants receiving Adalimumab for Pyoderma Gangrenosum (PG).

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients

You may qualify if:

• Diagnosed with Pyoderma Gangrenosum (PG).
• Have been prescribed Humira for PG treatment within 14 days.

You may not qualify if:

• \- Have Pyoderma Gangrenosum (PG) in previous treatment with Humira.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (46)

NHO Nagoya Medical Center /ID# 246013

Nagoya, Aichi-ken, 460-0001, Japan

Location

Nagoya City University Hospital /ID# 233778

Nagoya, Aichi-ken, 467-8602, Japan

Location

Akita University Hospital /ID# 242706

Akita, Akita, 010-8543, Japan

Location

Kyushu University Hospital /ID# 247492

Fukuoka, Fukuoka, 812-8582, Japan

Location

Japanese Red Cross Fukuoka Hospital /ID# 244051

Fukuoka, Fukuoka, 815-8555, Japan

Location

Kurume University Hospital /ID# 246502

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Central Japan International Medical Center /ID# 239391

Minokamo-shi, Gifu, 505-8510, Japan

Location

Gunma University Hospital /ID# 239390

Maebashi, Gunma, 371-8511, Japan

Location

Sapporo Medical University Hospital /ID# 241180

Sapporo, Hokkaido, 060-8543, Japan

Location

Hokkaido University Hospital /ID# 252567

Sapporo, Hokkaido, 060-8648, Japan

Location

Hokkaido Medical Center /ID# 251657

Sapporo, Hokkaido, 063-0005, Japan

Location

Kansai Rosai Hospital /ID# 246592

Amagasaki-shi, Hyōgo, 660-8511, Japan

Location

Kobe University Hospital /ID# 249396

Kobe, Hyōgo, 650-0017, Japan

Location

Nishi-Kobe Medical Center /ID# 244224

Kobe, Hyōgo, 651-2273, Japan

Location

Ishikawa Prefectural Central Hospital /ID# 239089

Kanazawa, Ishikawa-ken, 920-8530, Japan

Location

Kanazawa University Hospital /ID# 248730

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Takamatsu Red Cross Hospital /ID# 240576

Takamatsu, Kagawa-ken, 760-0017, Japan

Location

Kagawa Prefectural Central Hospital /ID# 250193

Takamatsu, Kagawa-ken, 760-0065, Japan

Location

Teikyo University Mizonokuchi Hospital /ID# 244693

Kawasaki, Kanagawa, 213-8507, Japan

Location

Yokohama Municipal Citizen's Hospital /ID# 233779

Yokohama, Kanagawa, 221-0855, Japan

Location

Yokohama Minami Kyousai Hosp /ID# 252892

Yokohama, Kanagawa, 236-0037, Japan

Location

Kumamoto University Hospital /ID# 244050

Kumamoto, Kumamoto, 8608556, Japan

Location

Fukuchiyama City Hospital /ID# 246593

Fukuchiyama-shi, Kyoto, 620-8505, Japan

Location

Mie University Hospital /ID# 238747

Tsu, Mie-ken, 514-8507, Japan

Location

Tohoku University Hospital /ID# 252113

Sendai, Miyagi, 9808574, Japan

Location

Tohoku Medical and Pharmaceuti /ID# 230270

Sendai, Miyagi, 983-0005, Japan

Location

University of Miyazaki Hospital /ID# 241179

Miyazaki, Miyazaki, 889-1692, Japan

Location

Shinshu University Hospital /ID# 230272

Matsumoto-shi, Nagano, 390-8621, Japan

Location

Nara Medical University Hospital /ID# 241880

Kashihara-shi, Nara, 634-8522, Japan

Location

Okayama University Hospital /ID# 238746

Okayama, Okayama-ken, 700-8558, Japan

Location

Okinawa Kyodo Hospital /ID# 241739

Naha, Okinawa, 900-0024, Japan

Location

Naha City Hospital /ID# 240818

Naha, Okinawa, 902-0061, Japan

Location

University of the Ryukyus Hospital /ID# 252114

Nakagami-gun, Okinawa, 903-0215, Japan

Location

Kansai Medical University Hospital /ID# 228783

Hirakata-shi, Osaka, 573-1191, Japan

Location

Japanese Red Cross Osaka Hospital /ID# 228782

Osaka, Osaka, 543-8555, Japan

Location

Kindai University Hospital /ID# 252568

Osakasayama-shi, Osaka, 589-8511, Japan

Location

Dokkyo Medical University Saitama Medical Center /ID# 248731

Koshigaya, Saitama, 343-0845, Japan

Location

Hamamatsu University Hospital /ID# 240817

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Chutoen General Medical Center /Id# 228780

Kakegawa-shi, Shizuoka, 436-0040, Japan

Location

Shizuoka Saiseikai Genaral Hospital /ID# 239088

Shizuoka, Shizuoka, 422-8527, Japan

Location

The University of Tokyo Hospital /ID# 250194

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

The Jikei University Hospital /ID# 252112

Minato-ku, Tokyo, 105-8471, Japan

Location

Tokyo Medical University Hospital /ID# 233780

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Yamanashi Kosei Hospital /ID# 242168

Yamanashi, Yamanashi, 405-0033, Japan

Location

Takatsuki General Hospital /ID# 244694

Osaka, Japan

Location

Teikyo University Hospital /ID# 239389

Tokyo, 173-8605, Japan

Location

Related Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

MeSH Terms

Conditions

Pyoderma Gangrenosum

Condition Hierarchy (Ancestors)

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

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 11, 2021
• Study Start: February 12, 2021
• Primary Completion: November 11, 2024
• Study Completion: November 11, 2024
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

JP (46)