UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035583 |
|---|---|
| Receipt number | R000040501 |
| Scientific Title | Factor analysis of bone erosion progression in rheumatoid arthritis patients receiving csDMARDs - Analysis using data from the placebo groups of the DRIVE and DESIRABLE studies - |
| Date of disclosure of the study information | 2019/01/18 |
| Last modified on | 2020/01/20 06:37:00 |
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Basic information
Public title
Factor analysis of bone erosion progression in rheumatoid arthritis patients receiving csDMARDs
- Analysis using data from the placebo groups of the DRIVE and DESIRABLE studies -
Acronym
Factor analysis of bone erosion progression in rheumatoid arthritis patients receiving csDMARDs
Scientific Title
Factor analysis of bone erosion progression in rheumatoid arthritis patients receiving csDMARDs
- Analysis using data from the placebo groups of the DRIVE and DESIRABLE studies -
Scientific Title:Acronym
Factor analysis of bone erosion progression in rheumatoid arthritis patients receiving csDMARDs
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To characterize patients with high risk of bone erosion progression by factor analysis of bone erosion progression in rheumatoid arthritis patients receiving csDMARDs
Basic objectives2
Others
Basic objectives -Others
Disease progression
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Odds ratio, 95% CI, and P value (univariate and multivariate model) of each factor for the presence/ absence of progression of Erosion score (ES) at 12 months (progression is defined as change in ES >0.5).
Key secondary outcomes
-Odds ratio, 95% CI, and P value (univariate and multivariate model) of each factor for the presence/ absence of progression of JSN score at 12 months (progression is defined as change in JSN >0.5).
-Odds ratio, 95% CI, and P value (univariate and multivariate model) of each factor for the presence/ absence of progression of TSS score at 12 months (progression is defined as change in TSS >0.5).
Base
Study type
Others,meta-analysis etc
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
Patients who were randomized to the placebo group in the DRIVE and DESIRABLE studies
Key exclusion criteria
1) Patients who did not received investigational medication once even after randomization.
2) Patients who did not have an available X-ray score at baseline and at least one time point after administration.
Target sample size
306
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Nakagaki |
Organization
Daiichi Sankyo Co.,LTD
Division name
Medical Science Department
Zip code
Address
3-5-1,Nihonbashi Honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1046
nakagaki.hisashi.sh@daiichisankyo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makiko Kobayashi |
Organization
Daiichi Sankyo Co.,LTD
Division name
Medical Science Department, Oncology & Pain Group
Zip code
Address
3-5-1,Nihonbashi Honcho, Chuo-ku, Tokyo, Japan
TEL
03-6225-1046
Homepage URL
kobayashi.makiko.vj@daiichisankyo.co.jp
Sponsor or person
Institute
Daiichi Sankyo Co.,LTD, Medical Science Department
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2019 | Year | 01 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/full/10.1080/14397595.2019.1703484
Number of participants that the trial has enrolled
306
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
| 2018 | Year | 10 | Month | 03 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
n/a
Management information
Registered date
| 2019 | Year | 01 | Month | 18 | Day |
Last modified on
| 2020 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040501
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
