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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031019
Receipt No. R000035407
Scientific Title An uncontrolled intervention trial on the effect of denosumab on QOL in patients with rheumatoid arthritis
Date of disclosure of the study information 2018/03/01
Last modified on 2019/05/15

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Basic information
Public title An uncontrolled intervention trial on the effect of denosumab on QOL in patients with rheumatoid arthritis
Acronym An uncontrolled intervention trial on the effect of denosumab on QOL in patients with rheumatoid arthritis
Scientific Title An uncontrolled intervention trial on the effect of denosumab on QOL in patients with rheumatoid arthritis
Scientific Title:Acronym An uncontrolled intervention trial on the effect of denosumab on QOL in patients with rheumatoid arthritis
Region
Japan

Condition
Condition rheumatoid arthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of EQ-5D change at 42 months after administration from baseline.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The value of EQ-5D at 42 months after administration
Key secondary outcomes inflammatory cytokine, Bone mineral density, bone turnover marker, blood test data, disease activity, image evaluation, adverse event, the retention rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 PRALIA 60mg subcutaneous injection every 6 months for 36 months.
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 who are 20 years old or more at the time of consent acquisition.
(2)Patients with RA diagnosed according to 1987 ACR criteria or 2010 ACR / EULAR criteria for RA.
(3)Patients from which written informed consent to participate in this trial was obtained.
Key exclusion criteria (1)Patients with osteoporosis
(2)Serum Ca value < 8.0 mg / dL
(3)Patients who are treated with RANMARK.
(4)Moderate or higher renal failure
(5)gingivitis or receiving dental procedures.
(6)Dementia or mental disorder.
(7)drug hypersensitivity
(8)Pregnant women and patients who may be pregnant or breast-feeding patients
(9)Patients who participated in other clinical trials within 4 months
(10)Patients judged inappropriate for participation in this trial by the person in charge.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Shinya
Middle name
Last name Hayashi
Organization Kobe University Hospital
Division name Department of Orthopaedic Surgery
Zip code 650-0017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL 078-382-5985
Email s11793290@yahoo.co.jp

Public contact
Name of contact person
1st name Shinya
Middle name
Last name Hayashi
Organization Kobe University Hospital
Division name Department of Orthopaedic Surgery
Zip code 650-0017
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
TEL 078-382-5985
Homepage URL
Email s11793290@yahoo.co.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization Kobe University
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 Kobe University hospital clinical and translational research center
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, 650-0017, Japan
Tel 078-382-6669
Email chiken@med.kobe-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

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 01 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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 20 Day
Date of IRB
2018 Year 03 Month 26 Day
Anticipated trial start date
2018 Year 03 Month 26 Day
Last follow-up date
2024 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 26 Day
Last modified on
2019 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035407

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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