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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023510
Receipt No. R000027080
Scientific Title Loop PsA Cross-sectional observational study evaluating clinical specialty setting as determinant of management of patients with psoriatic arthritis
Date of disclosure of the study information 2016/08/05
Last modified on 2017/11/14

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Basic information
Public title Loop PsA
Cross-sectional observational study evaluating clinical specialty setting as determinant of management of patients with psoriatic arthritis
Acronym Loop_PsA
Scientific Title Loop PsA
Cross-sectional observational study evaluating clinical specialty setting as determinant of management of patients with psoriatic arthritis
Scientific Title:Acronym Loop_PsA
Region
Japan Asia(except Japan) South America
Europe

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

Objectives
Narrative objectives1 To evaluate the association between the clinical specialty setting and time from inflammatory musculoskeletal symptom onset to PsA diagnose and to different management steps in patients with a confirmed PsA diagnosis
Basic objectives2 Others
Basic objectives -Others Research on the factor influencing management of PsA
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ・Time from inflammatory musculoskeletal symptom onset to PsA diagnosis
・Time from PsA diagnosis to first csDMARD
・Time from PsA diagnosis to first bDMARD
・Time from first csDMARD to first bDMARD
Key secondary outcomes PsA disease activity
・Joint disease activity (TJC/SJC, enthesitis count and dactylitis count, axial involvement by ASDAS)
・Skin disease activity (PGA, BSA, psoriatic nails count)

Disease burden
・Physical function (HAQ-DI score)
・Quality of life (SF12v2.0 score)
・Work productivity (WPAI scores)
・DLQI score

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ・Diagnosed with suspected or established PsA
・Female or male
・Age of 18 years or older
・Signed a patient authorization form to use and disclose personal health information (or informed consent, where applicable)
・Able to read and understand patients questionnaires in provided language
Key exclusion criteria No formal Exclusion criteria exist
Target sample size 1200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Adachi
Organization Abbvie GK
Division name Medical
Zip code
Address 3-5-27, Minato-ku, Tokyo
TEL 03-4577-1234
Email susumu.adachi@abbvie.com

Public contact
Name of contact person
1st name
Middle name
Last name Sarina Kurimoto
Organization Abbvie GK
Division name Medical
Zip code
Address 3-5-27, Minato-ku, Tokyo
TEL 03-4577-1234
Homepage URL
Email sarina.kurimoto@abbvie.com

Sponsor
Institute Abbvie GK
Institute
Department

Funding Source
Organization Abbvie GK
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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
2016 Year 08 Month 05 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
2015 Year 11 Month 06 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 15 Day
Last follow-up date
2017 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The prospective clinical study for specialty assessments of psoriatic arthritis

Management information
Registered date
2016 Year 08 Month 05 Day
Last modified on
2017 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027080

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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