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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036838
Receipt No. R000041940
Scientific Title Observational study to examine the changes in bone metabolism and bone erosion after discontinuation of denosumab in patients with rheumatoid arthritis.
Date of disclosure of the study information 2019/06/03
Last modified on 2019/05/29

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Basic information
Public title Observational study to examine the changes in bone metabolism and bone erosion after discontinuation of denosumab in patients with rheumatoid arthritis.
Acronym Observational study to examine the changes in bone metabolism and bone erosion after discontinuation of denosumab in patients with rheumatoid arthritis.
Scientific Title Observational study to examine the changes in bone metabolism and bone erosion after discontinuation of denosumab in patients with rheumatoid arthritis.
Scientific Title:Acronym Observational study to examine the changes in bone metabolism and bone erosion after discontinuation of denosumab in patients with rheumatoid arthritis.
Region
Japan

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

Objectives
Narrative objectives1 To examine the changes in bone metabolism and bone erosion after discontinuation of denosumab in patients who participated in the phase III study of denosumab for rheumatoid arthritis (DESIRALBLE).
Basic objectives2 Others
Basic objectives -Others To examine the changes in bone mineral density at 2 years after discontinuation of denosumab.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Percent change in lumbar spine bone mineral density
Key secondary outcomes Changes in bone erosion score
Changes in bone turnover marker (CTX-I)

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients who can give voluntary written informed consent.
2)Among patients who participated in the Phase III clinical study of denosumab for rheumatoid arthritis (DESIRABLE), those who were still involved in DESIRABLE at its completion (July 3, 2017).
3) Outpatients who are visiting the same institution as they visited in DESIRABLE.
Key exclusion criteria 1)Patients without informed consent.
2)Patients who are diagnosed with osteoporosis by the time of informed consent in this study.
3)Patients who have received denosumab other than during the phase III study (DESIRABLE).
4)Patients who received bisphosphonates after the date of completion of the DESIRABLE (July 3, 2017).
5)Women who are pregnant or possibly pregnant.
6)Other patients who the investigator considers to be ineligible.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Hisashi
Middle name
Last name Nakagaki
Organization Daiichi Sankyo Co., Ltd.
Division name Medical Science Department
Zip code 103-8426
Address 3-5-1, Nihonbashi-honcho, Chuo-ku, Tokyo
TEL 03-6225-1555
Email nakagaki.hisashi.sh@daiichisankyo.co.jp

Public contact
Name of contact person
1st name Hideaki
Middle name
Last name Sainomoto
Organization Daiichi Sankyo RD Novare Co., Ltd
Division name Clinical Development
Zip code 140-8710
Address 1-2-58, Hiromachi, Shinagawa-ku, Tokyo ,Japan
TEL 03-5436-8542
Homepage URL
Email sainomoto.hideaki.mb@rdn.daiichisankyo.co.jp

Sponsor
Institute Daiichi Sankyo Co., Ltd.
Institute
Department

Funding Source
Organization Daiichi Sankyo Co., Ltd.
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 Clinical research promotion network japan
Address 1-4-9,Itachibori, Nishi-ku, Osaka, Japan
Tel 06-4393-8403
Email osaka@sct-net.org

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 06 Month 03 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 Preinitiation
Date of protocol fixation
2019 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 05 Month 24 Day
Last modified on
2019 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041940

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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