UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the Usefulness of Adalimumab in Patients with Psoriatic arthritis
Title of the study (Brief title)	Evaluation of the Usefulness of Adalimumab for Psoriatic arthritis
Region	Japan

Condition
Condition	psoriatic arthritis
Classification by specialty	Clinical immunology Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ACR20 response rate (at Week 12)
Key secondary outcomes	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)

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	adalimumab
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(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
Key exclusion criteria	(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
Target sample size	50

Research contact person
Name of lead principal investigator	Akimichi Morita
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Geriatric and Environmental Dermatology
Address	Mizuho-ku, Nagoya 467-8601
TEL	052-853-8261
Email	amorita@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Tatsumi Shimuzu
Organization	EPS Corporation
Division name	CRO Business Division, Clinical Information Business Department
Address	Horiuchi Building, 3-25-9 Meieki, Nakamura-ku, Nagoya City, Aichi Prefecture, 450-0002
TEL	052-581-8887
Homepage URL
Email	prj-pcsg@eps.co.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences, Department of Geriatric and Environmental Dermatology
Institute
Department

Funding Source
Organization	Eisai Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 06 Day
Anticipated trial start date	2015 Year 02 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 02 Month 14 Day
Last modified on	2018 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019177