UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030575
Receipt No. R000034909
Scientific Title Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients. An open label randomized controlled trial by HR-pQCT.
Date of disclosure of the study information 2017/12/26
Last modified on 2019/06/18

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.
An open label randomized controlled trial by HR-pQCT.
Acronym Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.
An open label randomized controlled trial by HR-pQCT.
Scientific Title Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.
An open label randomized controlled trial by HR-pQCT.
Scientific Title:Acronym Comparative study of the inhibitory effect on bone erosion progression with Denosumab treatment and conventional treatment in rheumatoid arthritis patients.
An open label randomized controlled trial by HR-pQCT.
Region
Japan

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

Objectives
Narrative objectives1 To compare inhibitory effect on bone erosion progression in Denosumab treatment and conventional treatment in rheumatoid arthritis patients under treatment with csDMARDs.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Depth change from baseline of bone erosion by HR-pQCT measurement 6 months after starting administration.
Measurement part: second, third metacarpal bone
Key secondary outcomes Depth change from baseline of bone erosion by HR-pQCT measurement 12 months after starting administration.
Measurement part: second, third metacarpal bone

Depth change from baseline of bone erosion by HR-pQCT measurement.
Measurement part: wrist joint

Width and Volume change from baseline of bone erosion by HR-pQCT measurement.
Measurement part: second, third metacarpal bone and wrist joint

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients of the group that starts treatment of Denosumab will be treated with Denosumab at the time of visit on Month 0 and Month 6.
Interventions/Control_2 Patients of the group that continues conventional treatment will be not treated with Denosumab as a rule.
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 who can be visited hospital diagnosed as rheumatoid arthritis by Rheumatoid arthritis classification criteria of ACR (revised in 1987) or ACR / EULAR (2010)
2) Patients with low or moderate disease activity
3) Patients under treatment with csDMARDs.
4) Patients with progressive bone erosion in image examination (either X-ray, MRI or ultrasound)
5) Patients who are 20 years older at the time of obtaining informed consent and can consent to the document to participate by my own will
6) Male and Female
7) Outpatient only
Key exclusion criteria 1) Patients complicated of osteoporosis who have not been treated for osteoporosis
2) Patients under treatment with intravenous bisphosphonate formulation and parathyroid hormone formulation
3) Patients under treatment with Denosumab
4) Patients under treatment with Biological disease-modifying anti-rheumatic drug and JAK inhibitor
5) Patients taking adrenal cortex hormone drug in excess of 10 mg / day in terms of prednisolone
6) Patients with a history of hypersensitivity to the components of Desnomab
7) Patients with hypocalcemia
8) Patients who are or may be pregnant
9) Patients currently participating in trials or studies of other medicines or medical devices
10) Patients who are breastfeeding or who want pregnancy during the study period
11) Patients who jugged unsuitable for this study by the investigator
Target sample size 44

Research contact person
Name of lead principal investigator
1st name Atsushi
Middle name
Last name Kawakami
Organization Nagasaki University Hospital
Division name Department of Immunology and Rheumatology
Zip code 852-8501
Address 1-7-1 Sakamoto Nagasaki, Nagasaki
TEL 095-819-7200
Email atsushik@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Shigetoshi
Middle name
Last name Kageyama
Organization EP-CRSU Co., Ltd
Division name Business promotion department
Zip code 162-0814
Address Acropolis Tokyo Bldg. 3F 6-29 Shinogawamachi, Shinjuku-ku, Tokyo
TEL 03-6759-9900
Homepage URL
Email kageyama862@eps.co.jp

Sponsor
Institute Daiichi Sankyo Company, Limited
Institute
Department

Funding Source
Organization Daiichi Sankyo Company, Limited
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagasaki University Hospital Clinical Research Ethics Committee
Address 1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel 095-819-7229
Email gaibushikin@ml.nagasaki-u.ac.jp

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 長崎大学病院(長崎県)

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 26 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 Open public recruiting
Date of protocol fixation
2017 Year 12 Month 04 Day
Date of IRB
2018 Year 01 Month 16 Day
Anticipated trial start date
2018 Year 03 Month 31 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

Management information
Registered date
2017 Year 12 Month 26 Day
Last modified on
2019 Year 06 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034909

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.