A Phase 3 interventional study of adalimumab in Pyoderma Gangrenosum, sponsored by AbbVie. Completed at 20 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-09.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
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).
36 studies on the registry are indexed under Pyoderma Gangrenosum; 7 are open to participants now.
This study's enrollment of 22 is above the median of 10 across 26 interventional studies indexed under Pyoderma Gangrenosum.
Browse Pyoderma Gangrenosum studies →AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receiving adalimumab for Pyoderma Gangrenosum active ulcer(s).
Drug: adalimumab
Study drug will be administered subcutaneously.
Also known as: Humira®
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.
Time frame: Week 26
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.
Time frame: Week 6 and Week 26
Mean time to occurrence of new PG ulcers
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 6 and Week 26
Changes from Baseline in total ulcer area
The change in total ulcer area is assessed.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 26
Percentage change in target Pyoderma Gangrenosum (PG) ulcer area
The percentage change in target PG ulcer area is assessed.
Time frame: 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.
Time frame: 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.
Time frame: Week 6 and Week 26
Changes from baseline in the proportion of participants taking analgesics
Proportion of participants taking analgesics is assessed.
Time frame: Week 6 and Week 26
Velocities of healing
This is assessed from baseline.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Week 26
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access criteria: 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.
Data sharing details ↗ · www.abbvie.com
Ran from Oct 2017 to primary completion in Aug 2019, 21 months.
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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Adalimumab