UMIN-CTR Clinical Trial

Basic information
Public title	Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritis
Acronym	Study of ultrasound detected residual synovitis in rheumatoid arthritis
Scientific Title	Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritis
Scientific Title:Acronym	Study of ultrasound detected residual synovitis in rheumatoid arthritis
Region	Japan

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

Objectives
Narrative objectives1	To study pathology of local synovitis in rheumatoid arthritis treated with combination of anti-rheumatic therapy and denosumab. We use ultrasonography, magnetic resonance imaging and X-ray of finger joints to observe local synovitis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Joint ultrasonography and clinical assessments are examined at the baseline, 8th, 16th, 24 and 52nd week. Magnetic resonance imaging of finger joints and X-ray are performed at the baseline, 24th and 52nd week.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Combination of anti-rheumatic therapy and denosumab
Interventions/Control_2	Anti-rheumatic therapy alone
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient who are satisfied the criteria below: 1) Patients who are satisfied American College of Rheumatology (ACR) 1987 RA classification criteria and/or 2010 ACR/Eulopean League Against Rheumatism (EULAR) classification criteria 2) Patients diagnosed as active state of RA according to clinical information 3) Patients who need to start or adjust anti-rheumatic therapy 4) Patients are informed of this protocol and consented to participated
Key exclusion criteria	Patients who fulfill one of the following criteria must be excluded: 1) Patients who have apparent infection 2) Female patients who are during pregnancy or lactation 3) Patients who are judged to be inappropriate by investigator
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Fukae
Organization	Hokkaido Medical Center for Rheumatic Diseases
Division name	Center for Rheumatic Diseases
Zip code	063-0811
Address	1-45, 3-chome, Kotoni-1jo, Nishi-ku, Sapporo, Hokkaido
TEL	011-611-1371
Email	jun.fukae@ryumachi-jp.com

Public contact
Name of contact person	1st name Jun Middle name Last name Fukae
Organization	Hokkaido Medical Center for Rheumatic Diseases
Division name	Center for Rheumatic Diseases
Zip code	063-0811
Address	1-45, 3-chome, Kotoni-1jo, Nishi-ku, Sapporo, Hokkaido
TEL	011-611-1371
Homepage URL
Email	jun.fukae@ryumachi-jp.com

Sponsor
Institute	Hokkaido Medical Center for Rheumatic Diseases
Institute
Department

Funding Source
Organization	Hokkaido Medical Center for Rheumatic Diseases
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	Ethics committees of Hokkaido Medical Center for Rheumatic Diseases
Address	1-45 3-Chome, 1-Jo, Kotoni, Nishi-ku, Sapporo 063-0811, Japan.
Tel	011-611-1371
Email	jun.fukae@ryumachi-jp.com

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	北海道内科リウマチ科病院（札幌市）

Other administrative information
Date of disclosure of the study information	2017 Year 08 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	Terminated
Date of protocol fixation	2017 Year 07 Month 24 Day
Date of IRB	2017 Year 07 Month 01 Day
Anticipated trial start date	2017 Year 07 Month 26 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	Objective: To study the pathology of synovitis of finger joint in patients with RA Design: prospective interventional study Sampling: Patients were examined by joint imaging assessments through study

Management information
Registered date	2017 Year 07 Month 26 Day
Last modified on	2020 Year 01 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032475