UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028376 |
|---|---|
| Receipt number | 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 | 2020/01/27 15:31:41 |
* 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
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
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
jun.fukae@ryumachi-jp.com
Sponsor or person
Institute
Hokkaido Medical Center for Rheumatic Diseases
Institute
Department
Personal name
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
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
Value
https://center6.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 |
