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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035583
Receipt No. 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 2019/01/18

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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
Email 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
Email kobayashi.makiko.vj@daiichisankyo.co.jp

Sponsor
Institute Daiichi Sankyo Co.,LTD, Medical Science Department
Institute
Department

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
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
2019 Year 01 Month 18 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 No longer recruiting
Date of protocol fixation
2018 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 03 Day
Last follow-up date
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
2019 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.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


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