UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028875 |
|---|---|
| Receipt number | R000032911 |
| Scientific Title | The Reduction or withdrawal of MTX in patients with Rheumatoid Arthritis who achieve low disease activity |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2023/09/06 16:15:52 |
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Basic information
Public title
The Reduction or withdrawal of MTX in patients with Rheumatoid Arthritis who achieve low disease activity
Acronym
The Reduction or withdrawal of MTX in patients with Rheumatoid Arthritis
Scientific Title
The Reduction or withdrawal of MTX in patients with Rheumatoid Arthritis who achieve low disease activity
Scientific Title:Acronym
The Reduction or withdrawal of MTX in patients with Rheumatoid Arthritis
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the bone and cartilage damage after reducee and cease MTX dose for RA patients whom were prescribing MTX and their disease activity less than the degree of low class is maintaining over 24 or more weeks (DAS28-CRP < 2.7)
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the bone and cartilage damage (total sharp Score) after one year
Key secondary outcomes
Disease activity Score(DAS)-CRP, DAS28-ESR, CDAI, SDAI and HAQ
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We assess the bone and cartilage damage after reduce and cease MTX dose for RA patients whom were prescribing MTX and their disease activity less than the degree of low class is maintaining over 24 or more weeks (DAS28-CRP < 2.7)
Key exclusion criteria
All participants underwent US examination using both greyscale and power Doppler (PD) technique. We exclude the Patients who have joint soft tissue inflammation over Grade 1 by PDUS method.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Kou |
| Middle name | |
| Last name | Katayama |
Organization
ASAHIKAWA Medical University
Division name
Orthopedics
Zip code
0788510
Address
1-1 Midorigaoka 2 jo 1 chome Asahikawa
TEL
0166-65-2111
kou@kata-rheum.or.jp
Public contact
Name of contact person
| 1st name | Kou |
| Middle name | |
| Last name | Katayama |
Organization
Katayama Seikeigeka Rheumatism Clinic
Division name
Rheumatology
Zip code
0788510
Address
5-17 Toyooka 13 jo 4 chome Asahikawa
TEL
0166-39-1155
Homepage URL
kou@kata-rheum.or.jp
Sponsor or person
Institute
Asahikawa medical University
Institute
Department
Personal name
Funding Source
Organization
Katayama Seikeigeka Rheumatism Clinic
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sapporo Rheumatology and immunology clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Katayama orthopedic rheumatology clinic
Address
Toyooka13-4-5-17,Asahikawa
Tel
0166-39-1155
kou@kata-rheum.or.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
17036
Org. issuing International ID_1
Asahikawa medical University
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 | 09 | 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
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We assess the bone and cartilage damage after reduce and cease MTX dose for RA patients whom were prescribing MTX and their disease activity less than the degree of low class is maintaining over 24 or more weeks (DAS28-CRP < 2.7)
Management information
Registered date
| 2017 | Year | 08 | Month | 29 | Day |
Last modified on
| 2023 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032911
