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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028875
Receipt No. 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 2017/08/29

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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
Middle name
Last name Kou Katayama
Organization ASAHIKAWA Medical University
Division name Orthopedics
Zip code
Address 1-1 Midorigaoka 2 jo 1 chome Asahikawa
TEL 0166-65-2111
Email kou@kata-rheum.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kou Katayama
Organization Katayama Seikeigeka Rheumatism Clinic
Division name Rheumatology
Zip code
Address 5-17 Toyooka 13 jo 4 chome Asahikawa
TEL 0166-39-1155
Homepage URL
Email kou@kata-rheum.or.jp

Sponsor
Institute Asahikawa medical University
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2017 Year 08 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
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
2017 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032911

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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