UMIN-CTR Clinical Trial

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
Last 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
1st 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