Unique ID issued by UMIN | UMIN000014856 |
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Receipt number | R000016852 |
Scientific Title | Research for establishment and validation of therapeutic guideline aiming at "treatment holiday" in rheumatoid arthritis |
Date of disclosure of the study information | 2014/09/01 |
Last modified on | 2022/02/16 09:27:09 |
Research for establishment and validation of therapeutic guideline aiming at "treatment holiday" in rheumatoid arthritis
FREE-J study
Research for establishment and validation of therapeutic guideline aiming at "treatment holiday" in rheumatoid arthritis
FREE-J study
Japan |
rheumatoid arthritis
Clinical immunology |
Others
YES
To construct evidences for establishing a therapeutic guideline aiming at "drug holiday" in rheumatoid arthritis
Safety,Efficacy
Confirmatory
Pragmatic
Phase IV
DAS28(ESR) remission rate at 1 year after discontinuing biological DMARD
Observational
18 | years-old | <= |
Not applicable |
Male and Female
(1) Patient diagnosed as having rheumatoid arthritis according to ACR 1987 revised classification criteria for rheumatoid arthritis or ACR/EULAR 2010 revised classification criteria for rheumatoid arthritis.
(2) Patient maintained stable DAS28(ESR) remission at least 2 consecutive visits under treatment with biological DMARD and concomitant MTX (8mg/week).
(3) Patient;18 year-old with written informed consent for participating in the study.
(1) Patient with contraindication to MTX.
(2) Patient with contraindication to biological DMARD.
(3) Patient with any other reasons for inadequate to participate in this study, judege by attending rheumatologist.
500
1st name | Yoshiya |
Middle name | |
Last name | Tanaka |
University of Occupational and Environmental Health, Japan
The First Department of Internal Medicine
807-8555
1-1 Iseigaoka, Yahatanishi, Kitakyushu, 807-8555 Japan
+81-93-603-1611
tanaka@med.uoeh-u.ac.jp
1st name | Ayako |
Middle name | |
Last name | Yamaguchi |
University of Occupational and Environmental Health, Japan
The First Department of Internal Medicine
807-8555
1-1 Iseigaoka, Yahatanishi, Kitakyushu, 807-8555 Japan
+81-93-603-1611
ayasuzu@med.uoeh-u.ac.jp
University of Occupational and Environmental Health, Japan
self funding
Self funding
The First Department of Internal Medicine
1-1 Iseigaoka, Yahatanishi, Kitakyushu, 807-8555 Japan
+81-93-603-1611
ayasuzu@med.uoeh-u.ac.jp
NO
2014 | Year | 09 | Month | 01 | Day |
Partially published
436
Main results already published
2014 | Year | 06 | Month | 21 | Day |
2015 | Year | 06 | Month | 09 | Day |
2014 | Year | 12 | Month | 01 | Day |
2020 | Year | 06 | Month | 01 | Day |
2020 | Year | 10 | Month | 01 | Day |
2020 | Year | 10 | Month | 01 | Day |
If a patient with rheumatoid arthritis achieve DAS28 remission at two consequent visit, one can choose one out of five treatments below, then will be observed for two years.
1) Continue both MTX and bDMARD withouot reduction
2) Reduce MTX to a half dose
3) Withdraw MTX
4) Reduce bDMARD to a half dose
5) Withdraw bDMARD
2014 | Year | 08 | Month | 13 | Day |
2022 | Year | 02 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016852
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