UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012613 |
|---|---|
| Receipt number | R000014747 |
| Scientific Title | Reduction or withdrawal of etanercept after remission with etanerceptin patients with rheumatoid arthritis patients. |
| Date of disclosure of the study information | 2013/12/20 |
| Last modified on | 2013/12/17 21:46:43 |
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Basic information
Public title
Reduction or withdrawal of etanercept after remission with etanerceptin patients with rheumatoid arthritis patients.
Acronym
Reduction of etanercept after remission in RA patients.
Scientific Title
Reduction or withdrawal of etanercept after remission with etanerceptin patients with rheumatoid arthritis patients.
Scientific Title:Acronym
Reduction of etanercept after remission in RA patients.
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to assess whether remission would be sustained with reduced doses or withdrawal of etanercept in patients with rheumatoid arthritis after clinical remission. Additionally, investigation of optimum use of biologics also was the aim of this study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
activity score of rheumatoid arthritis: DAS(Disease Activity Score),swollen joint count, tender joint cont, ESR, patient VAS, CRP
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
etanercept50mg/wk or25mg twice/wk
reduction of etanercept to 25mg/wk arfter 3 months from remission
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients within remission stage(DAS28 under 2.6) after etanercept50mg/wk or25mg twice/wk
Key exclusion criteria
patients withoout remission stage(DAS28 under 2.6) after etanercept50mg/wk or25mg twice/wk
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikio Nakajima |
Organization
Osaka Medical College
Division name
Dept. of orthopedic surgery
Zip code
Address
Daigakumachi 2-7, Takatsuki, OSAKA
TEL
072-683-1221
ort054@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mikio Nakajima |
Organization
Osaka Medical College
Division name
Dept. of orthopedic surgery
Zip code
Address
Daigakumachi 2-7, Takatsuki, OSAKA
TEL
072-683-1221
Homepage URL
ort054@poh.osaka-med.ac.jp
Sponsor or person
Institute
Dept. of orthopedic surgery, Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Dept. of orthopedic surgery, Osaka Medical College
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 12 | Month | 20 | 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
| 2011 | Year | 10 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 17 | Day |
Last modified on
| 2013 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014747
