UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023153 |
|---|---|
| Receipt number | R000026692 |
| Scientific Title | Evaluation of clinical disease activity, work productivity, and psychological influence of biologics for rheumatoid arthritis or psoriatic arthritis |
| Date of disclosure of the study information | 2016/07/14 |
| Last modified on | 2019/01/19 17:24:33 |
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Basic information
Public title
Evaluation of clinical disease activity, work productivity, and psychological influence of biologics for rheumatoid arthritis or psoriatic arthritis
Acronym
Evaluation of clinical disease activity, work productivity, and psychological influence of biologics for rheumatoid arthritis or psoriatic arthritis
Scientific Title
Evaluation of clinical disease activity, work productivity, and psychological influence of biologics for rheumatoid arthritis or psoriatic arthritis
Scientific Title:Acronym
Evaluation of clinical disease activity, work productivity, and psychological influence of biologics for rheumatoid arthritis or psoriatic arthritis
Region
| Japan |
Condition
Condition
Rheumatoid arthritis, Psoriatic arthritis
Classification by specialty
| Clinical immunology | Dermatology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of clinical disease activity, work productivity, and psychological influence of biologics for rheumatoid arthritis or psoriatic arthritis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in variable parameters of biologics for rheumatoid arthritis or psoriatic arthritis.
Clinical disease activity to be assessed using DAS-ESR, DAS-CRP, SDAI, CDAI.
Work productivity to be assessed using WPAI.
Psychological influence to be assessed using WHO-5
Key secondary outcomes
Correlation between clinical disease activity and work productivity and psychological influence of biologics for rheumatoid arthritis or psoriatic arthritis
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with rheumatoid arthritis or psoriatic arthritis who are treated with a first biologic or a switching biologic
2) Patients must be able to sign the informed consent.
Key exclusion criteria
1) Patients who refuse to participate this study
2) Patients for whom the physicians do not think suitable for this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroko Kanda |
Organization
University of Tokyo
Division name
Department of Immunotherapy Management, Graduate School of Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
hkanda-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroko Kanda |
Organization
University of Tokyo
Division name
Department of Immunotherapy Management, Graduate School of Medicine
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
hkanda-tky@umin.ac.jp
Sponsor or person
Institute
Department of Immunotherapy Management, Graduate School of Medicine, University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Other
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 | 07 | Month | 14 | 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 | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
| 2019 | Year | 01 | Month | 19 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 02 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
We are analying the results.
Management information
Registered date
| 2016 | Year | 07 | Month | 13 | Day |
Last modified on
| 2019 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026692
