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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016543
Receipt No. 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

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Basic information
Public title Evaluation of the Usefulness of Adalimumab in Patients with Psoriatic arthritis
Acronym Evaluation of the Usefulness of Adalimumab for Psoriatic arthritis
Scientific Title Evaluation of the Usefulness of Adalimumab in Patients with Psoriatic arthritis
Scientific Title:Acronym 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
1st name
Middle name
Last name Akimichi Morita
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Geriatric and Environmental Dermatology
Zip code
Address Mizuho-ku, Nagoya 467-8601
TEL 052-853-8261
Email amorita@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsumi Shimuzu
Organization EPS Corporation
Division name CRO Business Division, Clinical Information Business Department
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 10 Month 06 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000019177

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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