UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027719 |
|---|---|
| Receipt number | R000031756 |
| Scientific Title | Effect of tapering methotrexate in rheumatoid arthritis patients after add-on iguratimod therapy. |
| Date of disclosure of the study information | 2017/06/12 |
| Last modified on | 2017/06/11 22:30:52 |
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Basic information
Public title
Effect of tapering methotrexate in rheumatoid arthritis patients after add-on iguratimod therapy.
Acronym
Effect of tapering MTX in RA patinents after add-on IGU theraoy.
Scientific Title
Effect of tapering methotrexate in rheumatoid arthritis patients after add-on iguratimod therapy.
Scientific Title:Acronym
Effect of tapering MTX in RA patinents after add-on IGU theraoy.
Region
| Japan |
Condition
Condition
rheumatoid arthritis/remission
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to examine the effect of tapering MTX in RA patients after add-on iguratimod therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
rate of sustaining remission after 36 weeks
Key secondary outcomes
ultrasound findings (power Doppler score, Grey scale score)
SF-36, HAQ, dose of MTX
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
add-on iguratimod
tapering MTX
Interventions/Control_2
continuing the treatment
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
sustaining DAS28ESR remission more than 6 months
Key exclusion criteria
add-on another csDMARDs or bDMARDs within 8 weeks.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuzo Yoshida |
Organization
Osama medical college
Division name
Department of Internal Medicine (4)
Zip code
Address
2-7 Daigakumachi, Takatsuki city, Osaka 569-8686, Japan
TEL
+81-72-683-1221
in1307@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuzo Yoshida |
Organization
Osaka Medical College
Division name
Department of Internal Medicine (4)
Zip code
Address
2-7 Daigakumachi, Takatsuki city, Osaka 569-8686, Japan
TEL
+81-72-683-1221
Homepage URL
in1307@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
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
Address
Tel
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
| 2017 | Year | 06 | Month | 12 | 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
| 2017 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 11 | Day |
Last modified on
| 2017 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031756
