A Study Assessing the Efficacy and Safety of Adalimumab in Active Ulcer(s) of Pyoderma Gangrenosum in Participants in Japan
- Registration Number
- NCT03311464
- Lead Sponsor
- AbbVie
- Brief Summary
This study is designed to investigate the efficacy, safety and pharmacokinetics of adalimumab in subjects in Japan with active ulcer(s) due to Pyoderma Gangrenosum (PG).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
- Participant must be able and willing to provide written informed consent. If the participant is < 20 years old, a parent or legal guardian must be willing to give written informed consent
- Participants must have a diagnosis of ulcerative (classic) PG made by the Investigator
- Participants must have demonstrated an inadequate response to conventional PG therapy or in the opinion of the Investigator they are not a suitable candidate for conventional PG treatment.
- Participants with pustular, bullous/atypical, or vegetative variants of PG
- Participants with clinical evidence of ulceration that is non-PG related, vasculitis, thrombosisprone conditions, or monoclonal gammopathy
- Participants with a histopathological finding that is consistent with a diagnosis other than PG
- Participants receiving a therapeutic dose of prednisolone
- Participants with prior exposure to adalimumab or previous participation in an adalimumab clinical study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm A adalimumab Participants receiving adalimumab for Pyoderma Gangrenosum active ulcer(s).
- Primary Outcome Measures
Name Time Method Proportion of participants who have achieved target Pyoderma Gangrenosum Area Reduction (PGAR) Week 26 The participants will be assessed whether they meet target PGAR at Week 26 based on PGAR score.
- Secondary Outcome Measures
Name Time Method Proportion of participants achieving Physician's Global Assessment (PGA) 0 or 1 Week 6 and Week 26 The Investigator assesses the global improvement of all ulcers including the target ulcer according to the scales at the specified visits.
Change from Baseline in Dermatology Life Quality Index (DLQI) Week 6 and Week 26 The DLQI will be used to assess the symptoms and the impact of skin problems on quality of life.
Mean time to healing as defined by PGAR Up to Week 26 The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.
Proportion of participants with inflammation reduction as assessed on an Investigator Inflammation Assessment (IIA) Score Up to Week 26 The Investigator assesses the inflammation status of the target ulcer at the specified visits according to the scales.
Mean time to occurrence of a new PG ulcer(s) Up to Week 52 Mean time to occurrence of a new PG ulcer(s) is assessed.
Mean time to occurrence of new PG ulcers Up to Week 26 A new PG ulcer is defined as not present at Baseline and not caused by the epithelial bridging of an existing ulcer at Baseline. The time after Baseline when the new lesion was observed will be recorded.
Changes from baseline in the proportion of participants taking analgesics Week 6 and Week 26 Proportion of participants taking analgesics is assessed.
Change from Baseline in total number of active ulcers Week 26 The number of all active PG ulcers will be counted at the specified visits.
Changes from Baseline in total ulcer area Week 6 and Week 26 The change in total ulcer area is assessed.
Mean time to healing of target ulcer Up to Week 52 The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.
Proportion of participants achieving ulcer healing as assessed by PGAR Week 6 The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.
Mean time to relapse of the target PG ulcer Up to Week 26 The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.
Proportion of participants who have achieved target PGAR Up to Week 26 The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.
Percentage change in target Pyoderma Gangrenosum (PG) ulcer area Up to Week 26 The percentage change in target PG ulcer area is assessed.
Proportion of participants achieving PGA 0 of all PG ulcers Week 52 The Investigator assesses the global improvement of all ulcers including the target ulcer according to the scales at the specified visits.
Proportion of participants achieving healing per PGAR for the target ulcer Week 52 The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline.
Proportion of participants achieving PGA 0 Week 6 and Week 26 The Investigator assesses the global improvement of all ulcers including the target ulcer according to the scales at the specified visits.
Change from Baseline in Pain as measured by Numerical Rating Scale (NRS) Week 6 and Week 26 The Numerical Rating Scale of Pain sheet will be filled out in the office by participants at the designated visits.
Velocities of healing Up to Week 26 This is assessed from baseline.
Trial Locations
- Locations (20)
Nagoya City University Hospital /ID# 164510
🇯🇵Nagoya-shi, Aichi, Japan
Juntendo University Urayasu Hospital /ID# 164422
🇯🇵Urayasu Shi, Chiba, Japan
Fukuoka University Hospital /ID# 164416
🇯🇵Fukuoka-shi, Fukuoka, Japan
Asahikawa Medical University Hospital /ID# 164589
🇯🇵Asahikawa-shi, Hokkaido, Japan
Showa University Fujigaoka Hospital /ID# 164406
🇯🇵Yokohama-shi, Kanagawa, Japan
Fukushima Medical University Hospital /ID# 164358
🇯🇵Fukushima-shi, Fukushima, Japan
Mie University Hospital /ID# 164389
🇯🇵Tsu-shi, Mie, Japan
Tohoku University Hospital /ID# 164360
🇯🇵Sendai-shi, Miyagi, Japan
Shinshu University Hospital /ID# 164852
🇯🇵Matsumoto-shi, Nagano, Japan
Nagasaki University Hospital /ID# 167604
🇯🇵Nagasaki-shi, Nagasaki, Japan
University of the Ryukyus Hospital /ID# 164981
🇯🇵Nakagami-gun, Okinawa, Japan
Hamamatsu University Hospital /ID# 165890
🇯🇵Hamamatsu-shi, Shizuoka, Japan
Tokushima University Hospital /ID# 164359
🇯🇵Tokushima-shi, Tokushima, Japan
Teikyo University Hospital /ID# 165665
🇯🇵Itabashi-ku, Tokyo, Japan
Tokyo Medical University Hospital /ID# 165810
🇯🇵Shinjuku-ku, Tokyo, Japan
Hokkaido University Hospital /ID# 164419
🇯🇵Sapporo, Japan
Keio University Hospital /ID# 165680
🇯🇵Shinjuku-ku, Tokyo, Japan
Yamaguchi University Hospital /ID# 164562
🇯🇵Ube-shi, Yamaguchi, Japan
Kansai Medical Univ Hosp /ID# 165802
🇯🇵Hirakata-shi, Osaka, Japan
Gunma University Hospital /ID# 164464
🇯🇵Maebashi-shi, Gunma, Japan