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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028376
Receipt No. R000032475
Scientific Title Study of ultrasound detected residual synovitis treated with combination of anti-rheumatic therapy and denosumab in rheumatoid arthritis
Date of disclosure of the study information 2017/08/01
Last modified on 2017/07/26

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

Public contact
1st name of contact person
1st name
Middle name
Last name Jun Fukae
Organization Hokkaido Medical Center for Rheumatic Diseases
Division name Center for Rheumatic Diseases
Zip code
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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 26 Day
Last follow-up date
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
2017 Year 07 Month 26 Day


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

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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