Assessing the effects of Humira in adults with Pyoderma Gangrenosum
Post-marketing Observational Study for Humira in Participants Diagnosed With Pyoderma Gangrenosum (PG)
This study is testing how well Humira works and what side effects it might cause in adults with Pyoderma Gangrenosum.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | Adalimumab |
| Locations | 46 sites (Nagoya shi, Aichi and 45 other locations) |
| Trial ID | NCT04750213 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the incidence of adverse events and changes in disease state among adult patients diagnosed with Pyoderma Gangrenosum (PG) who are being treated with Humira (Adalimumab). Approximately 60 participants will be monitored across 60 sites in Japan, receiving Humira as prescribed by their physicians. Regular medical assessments and interviews will be conducted to track side effects and treatment efficacy. The study focuses on understanding the safety profile of Humira in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults diagnosed with Pyoderma Gangrenosum who have been prescribed Humira within the last 14 days.
Not a fit: Patients who have previously been treated with Humira for Pyoderma Gangrenosum will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of Humira for treating Pyoderma Gangrenosum, potentially improving patient outcomes.
How similar studies have performed: While Humira is the only approved treatment for Pyoderma Gangrenosum in Japan, this study's focus on adverse events is relatively novel and has not been extensively tested in similar contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nagoya shi, Aichi and 45 other locations
- Nagoya City University Hospital /ID# 233778 — Nagoya shi, Aichi, Japan (Recruiting)
- NHO Nagoya Medical Center /ID# 246013 — Nagoya-shi, Aichi, Japan (Recruiting)
- Akita University Hospital /ID# 242706 — Akita-shi, Akita, Japan (Recruiting)
- Kyushu University Hospital /ID# 247492 — Fukuoka-shi, Fukuoka, Japan (Recruiting)
- Japanese Red Cross Fukuoka Hospital /ID# 244051 — Fukuoka-shi, Fukuoka, Japan (Recruiting)
- Kurume University Hospital /ID# 246502 — Kurume-shi, Fukuoka, Japan (Recruiting)
- Central Japan International Medical Center /ID# 239391 — Minokamo-shi, Gifu, Japan (Recruiting)
- Gunma University Hospital /ID# 239390 — Maebashi-shi, Gunma, Japan (Recruiting)
- Sapporo Medical University Hospital /ID# 241180 — Sapporo-shi, Hokkaido, Japan (Recruiting)
- Hokkaido University Hospital /ID# 252567 — Sapporo-shi, Hokkaido, Japan (Recruiting)
- Kansai Rosai Hospital /ID# 246592 — Amagasaki-shi, Hyogo, Japan (Recruiting)
- Nishi-Kobe Medical Center /ID# 244224 — Kobe-shi, Hyogo, Japan (Completed)
- Kobe University Hospital /ID# 249396 — Kobe, Hyogo, Japan (Recruiting)
- Ishikawa Prefectural Central Hospital /ID# 239089 — Kanazawa-shi, Ishikawa, Japan (Recruiting)
- Kanazawa University Hospital /ID# 248730 — Kanazawa-shi, Ishikawa, Japan (Recruiting)
- Takamatsu Red Cross Hospital /ID# 240576 — Takamatsu-shi, Kagawa, Japan (Recruiting)
- Kagawa Prefectural Central Hospital /ID# 250193 — Takamatsu-shi, Kagawa, Japan (Recruiting)
- Teikyo University Mizonokuchi Hospital /ID# 244693 — Kawasaki, Kanagawa, Japan (Recruiting)
- Yokohama Municipal Citizen's Hospital /ID# 233779 — Yokohama-shi, Kanagawa, Japan (Recruiting)
- Yokohama Minami Kyousai Hosp /ID# 252892 — Yokohama-shi, Kanagawa, Japan (Recruiting)
- Kumamoto University Hospital /ID# 244050 — Kumamoto shi, Kumamoto, Japan (Recruiting)
- Mie University Hospital /ID# 238747 — Tsu-shi, Mie, Japan (Recruiting)
- Tohoku University Hospital /ID# 252113 — Sendai-shi, Miyagi, Japan (Recruiting)
- Tohoku Medical and Pharmaceuti /ID# 230270 — Sendai-shi, Miyagi, Japan (Recruiting)
- University of Miyazaki Hospital /ID# 241179 — Miyazaki-shi, Miyazaki, Japan (Recruiting)
- Shinshu University Hospital /ID# 230272 — Matsumoto-shi, Nagano, Japan (Recruiting)
- Nara Medical University Hospital /ID# 241880 — Kashihara-shi, Nara, Japan (Recruiting)
- Naha City Hospital /ID# 240818 — Naha, Okinawa, Japan (Recruiting)
- University of the Ryukyus Hospital /ID# 252114 — Nakagami-gun, Okinawa, Japan (Recruiting)
- Okinawa Kyodo Hospital /ID# 241739 — 那覇市, Okinawa, Japan (Recruiting)
- Kansai Medical University Hospital /ID# 228783 — Hirakata-shi, Osaka, Japan (Recruiting)
- Japanese Red Cross Osaka Hospital /ID# 228782 — Osaka-shi, Osaka, Japan (Recruiting)
- Kindai University Hospital /ID# 252568 — Osakasayama-shi, Osaka, Japan (Recruiting)
- Dokkyo Medical University Saitama Medical Center /ID# 248731 — Koshigaya, Saitama, Japan (Recruiting)
- Hamamatsu University Hospital /ID# 240817 — Hamamatsu-shi, Shizuoka, Japan (Recruiting)
- Chutoen General Medical Center /Id# 228780 — Kakegawa-shi, Shizuoka, Japan (Recruiting)
- Shizuoka Saiseikai Genaral Hospital /ID# 239088 — Shizuoka-shi, Shizuoka, Japan (Recruiting)
- The University of Tokyo Hospital /ID# 250194 — Bunkyo-ku, Tokyo, Japan (Recruiting)
- The Jikei University Hospital /ID# 252112 — Minato-ku, Tokyo, Japan (Recruiting)
- Tokyo Medical University Hospital /ID# 233780 — Shinjuku-ku, Tokyo, Japan (Recruiting)
- Yamanashi Kosei Hospital /ID# 242168 — Yamanashi City, Yamanashi, Japan (Recruiting)
- Fukuchiyama City Hospital /ID# 246593 — Fukuchiyama-shi, Japan (Recruiting)
- Okayama University Hospital /ID# 238746 — Okayama, Japan (Recruiting)
- Takatsuki General Hospital /ID# 244694 — Osaka, Japan (Recruiting)
- Hokkaido Medical Center /ID# 251657 — Sapporo-shi, Japan (Recruiting)
- Teikyo University /ID# 239389 — Tokyo, Japan (Recruiting)
Study contacts
- Study coordinator: AbbVie GK Clinical Trial Registration Desk
- Email: abbvie_jpn_info_clingov@abbvie.com
- Phone: +81-3-4577-1111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.