Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Participants receiving adalimumab for Pyoderma Gangrenosum active ulcer(s). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Drug | Study drug will be administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who have achieved target Pyoderma Gangrenosum Area Reduction (PGAR) | The participants will be assessed whether they meet target PGAR at Week 26 based on PGAR score. | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving Physician's Global Assessment (PGA) 0 or 1 | The Investigator assesses the global improvement of all ulcers including the target ulcer according to the scales at the specified visits. | Week 6 and Week 26 |
| Mean time to occurrence of new PG ulcers |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya City University Hospital /ID# 164510 | Nagoya | Aichi-ken | 467-8602 | Japan | ||
| Juntendo University Urayasu Hospital /ID# 164422 |
Not provided
| Label | URL |
|---|---|
| clinical study report synopsis | View source |
Not provided
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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. |
| Up to Week 26 |
| Change from Baseline in total number of active ulcers | The number of all active PG ulcers will be counted at the specified visits. | Week 26 |
| Change from Baseline in Dermatology Life Quality Index (DLQI) | The DLQI will be used to assess the symptoms and the impact of skin problems on quality of life. | Week 6 and Week 26 |
| Changes from Baseline in total ulcer area | The change in total ulcer area is assessed. | Week 6 and Week 26 |
| Proportion of participants with inflammation reduction as assessed on an Investigator Inflammation Assessment (IIA) Score | The Investigator assesses the inflammation status of the target ulcer at the specified visits according to the scales. | Up to Week 26 |
| Mean time to occurrence of a new PG ulcer(s) | Mean time to occurrence of a new PG ulcer(s) is assessed. | Up to Week 52 |
| Mean time to healing of target ulcer | The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline. | Up to Week 52 |
| Proportion of participants achieving healing per PGAR for the target ulcer | The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline. | Week 52 |
| Proportion of participants who have achieved target PGAR | The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline. | Up to Week 26 |
| Percentage change in target Pyoderma Gangrenosum (PG) ulcer area | The percentage change in target PG ulcer area is assessed. | Up to Week 26 |
| Proportion of participants achieving PGA 0 | The Investigator assesses the global improvement of all ulcers including the target ulcer according to the scales at the specified visits. | Week 6 and Week 26 |
| Change from Baseline in Pain as measured by Numerical Rating Scale (NRS) | The Numerical Rating Scale of Pain sheet will be filled out in the office by participants at the designated visits. | Week 6 and Week 26 |
| Changes from baseline in the proportion of participants taking analgesics | Proportion of participants taking analgesics is assessed. | Week 6 and Week 26 |
| Velocities of healing | This is assessed from baseline. | Up to Week 26 |
| Proportion of participants achieving ulcer healing as assessed by PGAR | The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline. | Week 6 |
| Proportion of participants achieving PGA 0 of all PG ulcers | The Investigator assesses the global improvement of all ulcers including the target ulcer according to the scales at the specified visits. | Week 52 |
| Mean time to relapse of the target PG ulcer | The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline. | Up to Week 26 |
| Mean time to healing as defined by PGAR | The PG Area Reduction (PGAR) is calculated as the percentage area change in the target PG ulcer from Baseline. | Up to Week 26 |
| Urayasu Shi |
| Chiba |
| 279-0021 |
| Japan |
| Fukuoka University Hospital /ID# 164416 | Fukuoka | Fukuoka | 814-0180 | Japan |
| Fukushima Medical University Hospital /ID# 164358 | Fukushima | Fukushima | 960-1295 | Japan |
| Gunma University Hospital /ID# 164464 | Maebashi | Gunma | 371-8511 | Japan |
| Asahikawa Medical University Hospital /ID# 164589 | Asahikawa-shi | Hokkaido | 078-8510 | Japan |
| Showa University Fujigaoka Hospital /ID# 164406 | Yokohama | Kanagawa | 227-0043 | Japan |
| Mie University Hospital /ID# 164389 | Tsu | Mie-ken | 514-8507 | Japan |
| Tohoku University Hospital /ID# 164360 | Sendai | Miyagi | 980-8574 | Japan |
| Shinshu University Hospital /ID# 164852 | Matsumoto-shi | Nagano | 〒390-8621 | Japan |
| Nagasaki University Hospital /ID# 167604 | Nagasaki | Nagasaki | 852-8501 | Japan |
| University of the Ryukyus Hospital /ID# 164981 | Nakagami-gun | Okinawa | 903-0215 | Japan |
| Hamamatsu University Hospital /ID# 165890 | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Tokushima University Hospital /ID# 164359 | Tokushima | Tokushima | 770-8503 | Japan |
| Teikyo University Hospital /ID# 165665 | Itabashi-ku | Tokyo | 173-8605 | Japan |
| Tokyo Medical University Hospital /ID# 165810 | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Keio University Hospital /ID# 165680 | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Yamaguchi University Hospital /ID# 164562 | Ube-shi | Yamaguchi | 7558505 | Japan |
| Kansai Medical Univ Hosp /ID# 165802 | Hirakata-shi, Osaka | 573-1191 | Japan |
| Hokkaido University Hospital /ID# 164419 | Sapporo | 060-8648 | Japan |
| ID | Term |
|---|---|
| D017511 | Pyoderma Gangrenosum |
| D014456 | Ulcer |
| ID | Term |
|---|---|
| D011711 | Pyoderma |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |
| D012883 | Skin Ulcer |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided