UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023510 |
|---|---|
| Receipt number | 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 18:04:03 |
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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
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
sarina.kurimoto@abbvie.com
Sponsor or person
Institute
Abbvie GK
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027080
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
