|
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-UMIN000015462 |
|
Date of registration:
|
17/10/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Clinical study on drug holiday with regulated rheumatoid arthritis activity after treatment with tofacitinib (Xanadu study)
|
|
Scientific title:
|
Clinical study on drug holiday with regulated rheumatoid arthritis activity after treatment with tofacitinib (Xanadu study) - Clinical study on rheumatoid arthritis treated with tofacitinib |
|
Date of first enrolment:
|
2014/10/01 |
|
Target sample size:
|
400 |
|
Recruitment status: |
Complete: follow-up complete |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017779 |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel Randomized
|
|
Phase:
|
Not selected
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Yoshiya Tanaka |
|
Address:
|
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
Japan |
|
Telephone:
|
093-603-1611 |
|
Email:
|
tanaka@med.uoeh-u.ac.jp |
|
Affiliation:
|
School of Medicine, University of Occupational and Environmental Health, Japan First Department of Internal Medicine |
|
|
Name:
|
Satoshi Kubo |
|
Address:
|
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
Japan |
|
Telephone:
|
093-603-1611 |
|
Email:
|
kubosato@med.uoeh-u.ac.jp |
|
Affiliation:
|
School of Medicine, University of Occupational and Environmental Health, Japan First Department of Internal Medicine |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Exclusion criteria: Patients judged as inadequate by the subinvestigator
Age minimum:
18years-old
Age maximum:
Not applicable
Gender:
Male and Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Rheumatoid arthritis
|
|
Intervention(s)
|
Continue current treatment
Tofacitinib discontinuation
MTX discontinuation
|
|
Primary Outcome(s)
|
|
SDAI remission, low disease activity rate DS28 remission rate, low disease activity rate
|
|
Secondary Outcome(s)
|
|
RF, MMP-3, CRP, ACPA, HAQ, Sharp score, adverse events
|
|
Source(s) of Monetary Support
|
|
none
|
|
Ethics review
|
Status: YES
Approval date: 01/05/2014
Contact:
|
|