Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
JPRN |
Last refreshed on:
|
17 October 2023 |
Main ID: |
JPRN-UMIN000012613 |
Date of registration:
|
20/12/2013 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Reduction or withdrawal of etanercept after remission with etanerceptin patients with rheumatoid arthritis patients.
|
Scientific title:
|
Reduction or withdrawal of etanercept after remission with etanerceptin patients with rheumatoid arthritis patients. - Reduction of etanercept after remission in RA patients. |
Date of first enrolment:
|
2012/01/01 |
Target sample size:
|
30 |
Recruitment status: |
Complete: follow-up complete |
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014747 |
Study type:
|
Interventional |
Study design:
|
Single arm Non-randomized
|
Phase:
|
Not selected
|
|
Countries of recruitment
|
Japan
| | | | | | | |
Contacts
|
Name:
|
Mikio Nakajima |
Address:
|
Daigakumachi 2-7, Takatsuki, OSAKA
Japan |
Telephone:
|
072-683-1221 |
Email:
|
ort054@poh.osaka-med.ac.jp |
Affiliation:
|
Osaka Medical College Dept. of orthopedic surgery |
|
Name:
|
Mikio Nakajima |
Address:
|
Daigakumachi 2-7, Takatsuki, OSAKA
Japan |
Telephone:
|
072-683-1221 |
Email:
|
ort054@poh.osaka-med.ac.jp |
Affiliation:
|
Osaka Medical College Dept. of orthopedic surgery |
| |
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: patients withoout remission stage(DAS28 under 2.6) after etanercept50mg/wk or25mg twice/wk
Age minimum:
20years-old
Age maximum:
70years-old
Gender:
Male and Female
|
Health Condition(s) or Problem(s) studied
|
rheumatoid arthritis
|
Intervention(s)
|
etanercept50mg/wk or25mg twice/wk reduction of etanercept to 25mg/wk arfter 3 months from remission
|
Primary Outcome(s)
|
activity score of rheumatoid arthritis: DAS(Disease Activity Score),swollen joint count, tender joint cont, ESR, patient VAS, CRP
|
Source(s) of Monetary Support
|
Dept. of orthopedic surgery, Osaka Medical College
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
Results
|
Results available:
|
Yes |
Date Posted:
|
|
Date Completed:
|
30/09/2013 |
URL:
|
|
|
|