Unique ID issued by UMIN | UMIN000016543 |
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Receipt number | R000019177 |
Scientific Title | Evaluation of the Usefulness of Adalimumab in Patients with Psoriatic arthritis |
Date of disclosure of the study information | 2015/02/17 |
Last modified on | 2018/08/20 09:19:44 |
Evaluation of the Usefulness of Adalimumab in Patients with Psoriatic arthritis
Evaluation of the Usefulness of Adalimumab for Psoriatic arthritis
Evaluation of the Usefulness of Adalimumab in Patients with Psoriatic arthritis
Evaluation of the Usefulness of Adalimumab for Psoriatic arthritis
Japan |
psoriatic arthritis
Clinical immunology | Dermatology |
Others
NO
To evaluating the influence of adalimumab (administered subcutaneously every other week for 24 weeks) on the articular symptoms, skin symptoms and QOL of Japanese patients with psoriatic arthritis and at comparing the results of evaluation with the efficacy data collected overseas in ADEPT Study. The study is additionally designed to conduct exploratory analysis of the efficacy of adalimumab using diagnostic imaging (MRI), PASDAS, etc. and correlation of adalimumab efficacy with changes in platelet markers.
Safety,Efficacy
Confirmatory
ACR20 response rate (at Week 12)
ACR20 response rate (at Week 24), ACR50/70 response rate (at Weeks 12 and 24)
Change in HAQ, change in DAS28CRP, change in BASDAI (at Weeks 12 and 24)
PASI50/75/90 response rate, change in PASI, change in PGA (at Weeks 12 and 24)
Change in SF-36, change in DLQI (at Weeks 12 and 24)
CRP, anti-CCP antibody, SAA, change in MMP-3 (at Weeks 12 and 24)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
adalimumab
20 | years-old | <= |
Not applicable |
Male and Female
(1) Patients having been informed sufficiently as to the objectives and design of the study and having issued written consent to the study at their own discretion
(2) Patients aged 20 or older on the date of consent acquisition
(3) Patients diagnosed as having psoriatic arthritis in accordance with CASPAR criteria
(4) Patients poorly responding to treatment with NSAIDs
(5) In cases being treated with NSAIDs, DMARDs or oral corticosteroids, patients having received the treatment at a stable dose level until 4 weeks before the start of this study
(1) Patients with other active skin disease possibly disturbing evaluation of psoriasis-related skin symptoms
(2) Patients having received intraarticular or intratendinous injection of steroid with 4 weeks before the start of this study
(3) Patients having received biological preparations during the period specified below:
Infliximab: within 8 weeks before the start of this study
Ustekinumab: within 12 weeks before the start of this study
Other biological preparations (including drugs on clinical trial): within 24 weeks before the start of this study
(4) Patients receiving ultraviolet ray therapy or using ciclosporin or etretinate at the start of this study of this study
(5) Patients with serious infection (sepsis, etc.)
(6) Patients with active tuberculosis
(7) Patients with a history of hypersensitivity to any component of the study drug
(8) Patients with demyelinating disease (multiple sclerosis, etc.) or its history
(9) Patients with congestive heart failure
(10) Other patients judged by the investigator or the like as inappropriate for this study
50
1st name | |
Middle name | |
Last name | Akimichi Morita |
Nagoya City University Graduate School of Medical Sciences
Department of Geriatric and Environmental Dermatology
Mizuho-ku, Nagoya 467-8601
052-853-8261
amorita@med.nagoya-cu.ac.jp
1st name | |
Middle name | |
Last name | Tatsumi Shimuzu |
EPS Corporation
CRO Business Division, Clinical Information Business Department
Horiuchi Building, 3-25-9 Meieki, Nakamura-ku, Nagoya City, Aichi Prefecture, 450-0002
052-581-8887
prj-pcsg@eps.co.jp
Nagoya City University Graduate School of Medical Sciences, Department of Geriatric and Environmental Dermatology
Eisai Co., Ltd.
Profit organization
Japan
NO
2015 | Year | 02 | Month | 17 | Day |
Unpublished
Completed
2014 | Year | 10 | Month | 06 | Day |
2015 | Year | 02 | Month | 17 | Day |
2015 | Year | 02 | Month | 14 | Day |
2018 | Year | 08 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019177
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