UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002175 |
|---|---|
| Receipt number | 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 10:59:55 |
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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
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
oribe-riuma@iris.ocn.ne.jp
Sponsor or person
Institute
POEM study group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002676
