UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009535 |
|---|---|
| Receipt number | R000011195 |
| Scientific Title | Suppress the joint destruction in clinical remission patients who have active synovitis of ultrasonographic assessment by increasing the dose of methotrexate |
| Date of disclosure of the study information | 2012/12/12 |
| Last modified on | 2020/03/16 19:10:38 |
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Basic information
Public title
Suppress the joint destruction in clinical remission patients who have active synovitis of ultrasonographic assessment by increasing the dose of methotrexate
Acronym
SCRUM study
Scientific Title
Suppress the joint destruction in clinical remission patients who have active synovitis of ultrasonographic assessment by increasing the dose of methotrexate
Scientific Title:Acronym
SCRUM study
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we predict the progression of joint destruction by using the (US) ultrasound joint and analyze whether the joint destruction is suppressed by increasing methotrexate (MTX) in clinical remission with rheumatoid arthritis (RA) patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the change of X-ray from baseline in the van der Heijde-Sharp score at week 52
Key secondary outcomes
the change of X-ray from baseline in the van der Heijde-Sharp score at week 24
the change of power doppler signal from baseline in the van der Heijde-Sharp score at week 24and 52
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We randomly assigned patients who have the positive joint of power Doppler signal by ultrasonography even in clinical remission to increase or stable the dose of MTX and observation .
MTX increase group was increased to 16mg, it will continue to increase as much as possible.
Interventions/Control_2
We randomly assigned patients who have the positive joint of power Doppler signal by ultrasonography even in clinical remission to increase or stable the dose of MTX and observation .
MTX increase group was increased to 16mg, it will continue to increase as much as possible.
Interventions/Control_3
We observe the patients if there is no positive joint power Doppler signal.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
RA patients fulfiling the American Rheumatology Association criteria 1987 and ACR/EULAR classification cliteria 2010.
The patients who have stable remission and 28-joint disease activity score CRP (DAS28-CRP) <2.6 for at least 3 months.
Key exclusion criteria
Patients who can not use oral MTX due to side effects.
Patients with other diseases that can affect the infllamation state.
Patients who was deemed inappropriate by test doctor to participate in this study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Okano |
Organization
Osaka City University Medical School
Division name
Orthopedic Surgery
Zip code
545-8585
Address
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL
0666453851
ma1sa3ru@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Okano |
Organization
Osaka City University Medical School
Division name
Orthopedic Surgery
Zip code
545-8585
Address
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL
0666453851
Homepage URL
ma1sa3ru@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Medical School
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Osaka City University Medical School
Address
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
Tel
06-6645-3851
ma1sa3ru@med.osaka-cu.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
| 2012 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
http://www.med.osaka-cu.ac.jp/orthoped/research/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.med.osaka-cu.ac.jp/orthoped/research/
Number of participants that the trial has enrolled
134
Results
Clinical remission according to composite indexes allowed the presence of subclinical active synovitis that might induce structural joint damages. Subclinical active synovitis should be controlled by additional treatment and this results in the prevention of the joint damage progression. Evaluation of subclinical active synovitis by using high resolution US should be important even in patients achieving clinical remission and it should be treated more intensively if active synovitis is positive.
Results date posted
| 2020 | Year | 03 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with RA in clinical remission defined as DAS (Disease activity score) 28-CRP<2.6.
Participant flow
Provide informed consent directly to the selected patients and have them give their consent in a written consent form.
Adverse events
Adverse events such as liver injury occurred in 15 patients, and the study was discontinued in this 15 patients
Outcome measures
DAS28/US/mTSS
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 12 | Day |
Last modified on
| 2020 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011195
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