UMIN-CTR Clinical Trial

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

psoriatic arthritis

Classification by specialty

Clinical immunology

Dermatology

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Eisai Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

02

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

02

Month

14

Day

Last modified on

2018

Year

08

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019177