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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002175
Receipt No. R000002676
Scientific Title Comparison of the clinical responses by the dosage of once or triple a week of MTX in patients with rheumatoid Arthritis
Date of disclosure of the study information 2009/07/10
Last modified on 2011/05/09

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Basic information
Public title Comparison of the clinical responses by the dosage of once or triple a week of MTX in patients with rheumatoid Arthritis
Acronym POEM study
Scientific Title Comparison of the clinical responses by the dosage of once or triple a week of MTX in patients with rheumatoid Arthritis
Scientific Title:Acronym POEM study
Region
Japan

Condition
Condition Rheumatoid Arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of the dosage of MTX a week
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes DAS28(CRP)
Key secondary outcomes EULAR Criteria
Patient's Judgement

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 MTX, once a week
Interventions/Control_2 MTX, triple a week
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
16 years-old <
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Rheumatoid Arthritis
Key exclusion criteria Disqualified in patients with rheumatoid arthritis who judged by a doctor
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motoriro Oribe
Organization Oribe Rheumatism Clinic
Division name Rheumatology
Zip code
Address 1-8-15, Higasioomichi, Oita-city, Oita, Japan
TEL 097-513-7123
Email

Public contact
Name of contact person
1st name
Middle name
Last name Motoriro Oribe
Organization Oribe Rheumatism Clinic
Division name Rheumatology
Zip code
Address 1-8-15, Higasioomichi, Oita-city, Oita, Japan
TEL 097-513-7123
Homepage URL
Email oribe-riuma@iris.ocn.ne.jp

Sponsor
Institute POEM study group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 07 Month 10 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 No longer recruiting
Date of protocol fixation
2009 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 06 Month 01 Day
Date trial data considered complete
2011 Year 07 Month 01 Day
Date analysis concluded
2011 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 07 Month 09 Day
Last modified on
2011 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002676

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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