A Study Assessing the Efficacy and Safety of Adalimumab in Active Ulcer(s) of Pyoderma Gangrenosum in Participants in Japan
NCT ID: NCT03311464
Last Updated: 2021-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
22 participants
INTERVENTIONAL
2017-10-27
2020-04-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm A
Participants receiving adalimumab for Pyoderma Gangrenosum active ulcer(s).
adalimumab
Study drug will be administered subcutaneously.
Interventions
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adalimumab
Study drug will be administered subcutaneously.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Nagoya City University Hospital /ID# 164510
Nagoya, Aichi-ken, Japan
Juntendo University Urayasu Hospital /ID# 164422
Urayasu Shi, Chiba, Japan
Fukuoka University Hospital /ID# 164416
Fukuoka, Fukuoka, Japan
Fukushima Medical University Hospital /ID# 164358
Fukushima, Fukushima, Japan
Gunma University Hospital /ID# 164464
Maebashi, Gunma, Japan
Asahikawa Medical University Hospital /ID# 164589
Asahikawa-shi, Hokkaido, Japan
Showa University Fujigaoka Hospital /ID# 164406
Yokohama, Kanagawa, Japan
Mie University Hospital /ID# 164389
Tsu, Mie-ken, Japan
Tohoku University Hospital /ID# 164360
Sendai, Miyagi, Japan
Shinshu University Hospital /ID# 164852
Matsumoto-shi, Nagano, Japan
Nagasaki University Hospital /ID# 167604
Nagasaki, Nagasaki, Japan
University of the Ryukyus Hospital /ID# 164981
Nakagami-gun, Okinawa, Japan
Hamamatsu University Hospital /ID# 165890
Hamamatsu, Shizuoka, Japan
Tokushima University Hospital /ID# 164359
Tokushima, Tokushima, Japan
Teikyo University Hospital /ID# 165665
Itabashi-ku, Tokyo, Japan
Tokyo Medical University Hospital /ID# 165810
Shinjuku-ku, Tokyo, 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
Hokkaido University Hospital /ID# 164419
Sapporo, , Japan
Countries
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Related Links
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clinical study report synopsis
Other Identifiers
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M16-119
Identifier Type: -
Identifier Source: org_study_id
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