Unique ID issued by UMIN | UMIN000010315 |
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Receipt number | R000012074 |
Scientific Title | Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessment |
Date of disclosure of the study information | 2013/03/26 |
Last modified on | 2020/03/16 16:21:41 |
Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessment
PROUD study
Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessment
PROUD study
Japan |
rheumatoid arthritis
Clinical immunology | Orthopedics |
Others
NO
In this study, we predict the factor of sustainment or recurrence after adalimumab discontinuation by using ultrasound assessment in clinical remission with rheumatoid arthritis (RA) patients.
Safety,Efficacy
Consider the possible state by results of ultrasound in the presence or absence of recurrence (DAS28-CRP <3.2) at week 24 after discontinuation of Adalimumab.
Consider the possible state by results of ultrasound in the presence or absence of recurrence (DAS28-CRP <3.2) at week 52 after discontinuation of Adalimumab.
the change of X-ray from baseline in the van der Heijde-Sharp score at week 24 and 52.
the change of ultrasound results from baseline at week 24and 52
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
In patients with clinical remission by adalimumab (DAS28-CRP <2.6) maintained over 24 weeks, to stop the Adalimumab.
20 | years-old | <= |
Not applicable |
Male and Female
RA patients fulling the American Rheumatology Association criteria 1987 and ACR/EULAR classification cliteria 2010.
The patients using adalimumab who have stable remission, as a 28-joint disease activity score CRP (DAS28-CRP) <2.6 for at least 24 weeks.
Patients with other diseases that can affect the infllamation state.
Patients using corticosteroids exceeding 5mg/day.
Patients who was deemed inappropriate by test doctor to participate in this study.
50
1st name | Tadashi |
Middle name | |
Last name | Okano |
Osaka City University Medical School
Orthopedic Surgery
545-8585
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
0666453851
ma1sa3ru@med.osaka-cu.ac.jp
1st name | Tadashi |
Middle name | |
Last name | Okano |
Osaka City University Medical School
Orthopedic Surgery
545-8585
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
0666453851
ma1sa3ru@med.osaka-cu.ac.jp
Osaka City University Medical School
Self funding
Self funding
Metabolism, Endocrinology, and Molecular Medicine. Osaka City University Graduate School of Medicine.
The center for rheumatic diseases. Nara Medical University.
Rheumatology. Kitano Hospital.
Osaka City University
1-4-3 Asahimachi, Abeno-ku
06-6645-3851
ma1sa3ru@med.osaka-cu.ac.jp
NO
2013 | Year | 03 | Month | 26 | Day |
http://www.med.osaka-cu.ac.jp/orthoped/research/
Unpublished
http://www.med.osaka-cu.ac.jp/orthoped/research/
53
As a result, baseline ultrasound data did not predict relapse on ADA withdrawal, but found that patients who had flared US findings three months later had a higher rate of subsequent relapse. From the results of this study, it was suggested that relapse could be predicted by changes of ultrasound findings in short time follow up.
2020 | Year | 03 | Month | 16 | Day |
Rheumatoid arthritis patients treated with Adalimumab (ADA) who have been in remission for more than 24 weeks (DAS28-CRP <2.6) and are scheduled to discontinue ADA.
Provide informed consent directly to the selected patients and have them give their consent in a written consent form.
This was a trial to discontinue the drug and no specific adverse events were reported.
DAS28/CRP/ESR/USGS score/USPD score
Completed
2012 | Year | 10 | Month | 01 | Day |
2012 | Year | 09 | Month | 03 | Day |
2012 | Year | 10 | Month | 01 | Day |
2018 | Year | 03 | Month | 31 | Day |
2013 | Year | 03 | Month | 26 | Day |
2020 | Year | 03 | Month | 16 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012074
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