UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013362 |
|---|---|
| Receipt number | R000015590 |
| Scientific Title | Examination of the remission maintenance effect by low dose etanercept after clinical remission in the rheumatoid arthritis. |
| Date of disclosure of the study information | 2014/03/06 |
| Last modified on | 2015/11/26 14:58:01 |
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Basic information
Public title
Examination of the remission maintenance effect by low dose etanercept after clinical remission in the rheumatoid arthritis.
Acronym
PRESERVATION OF REMISSION MAINTAENANCE BY LOW DOSE ETANERCEPT
Scientific Title
Examination of the remission maintenance effect by low dose etanercept after clinical remission in the rheumatoid arthritis.
Scientific Title:Acronym
PRESERVATION OF REMISSION MAINTAENANCE BY LOW DOSE ETANERCEPT
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect inspection of low dose etanercept in the remission maintenance therapy in the rheumaotoid arthritis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Remission maintenance rate
(DAS28,SDAI,CDAI)
SJC,TJC,CRP,MMP-3,RF,ESR
Key secondary outcomes
Funtional remission rate (HAQ,EQ5D)
Radiographic remission rate(mTSS)
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Methotrexate
Interventions/Control_2
Etanercept
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
The patient of rheumatoid arthritis who is treated by etanercept and who have achieved clinical remission over 6 months.
Key exclusion criteria
Patient with a history of the use of the preparation biological by temporary registration.
The patient who does not correspond to adaptation of the biologics.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Hagiwara |
Organization
Takarazuka city hospital
Division name
Department of Rheumatology
Zip code
Address
Takarazuka city
TEL
0797-87-5624
college@katzenauge.sakura.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takafumi Hagiwara |
Organization
Takarazuka city hospital
Division name
Departmentn of Rheumatology
Zip code
Address
Takarazuka city
TEL
0797(87)1161
Homepage URL
college@katzenauge.sakura.ne.jp
Sponsor or person
Institute
Takarazuka city hospital
Institute
Department
Personal name
Funding Source
Organization
Takarazuka city hospital
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 03 | Month | 06 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
| 2015 | Year | 11 | Month | 26 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 06 | Day |
Last modified on
| 2015 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015590
