UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010315 |
|---|---|
| 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 |
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Basic information
Public title
Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessment
Acronym
PROUD study
Scientific Title
Prediction of the recurrence after adalimumab discontinuation by using ultrasound assessment
Scientific Title:Acronym
PROUD study
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
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
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
In patients with clinical remission by adalimumab (DAS28-CRP <2.6) maintained over 24 weeks, to stop the Adalimumab.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Okano |
Organization
Osaka City University Medical School
Division name
Orthopedic Surgery
Zip code
545-8585
Address
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL
0666453851
ma1sa3ru@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Okano |
Organization
Osaka City University Medical School
Division name
Orthopedic Surgery
Zip code
545-8585
Address
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL
0666453851
Homepage URL
ma1sa3ru@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Medical School
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Metabolism, Endocrinology, and Molecular Medicine. Osaka City University Graduate School of Medicine.
The center for rheumatic diseases. Nara Medical University.
Rheumatology. Kitano Hospital.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City University
Address
1-4-3 Asahimachi, Abeno-ku
Tel
06-6645-3851
ma1sa3ru@med.osaka-cu.ac.jp
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 | 03 | Month | 26 | Day |
Related information
URL releasing protocol
http://www.med.osaka-cu.ac.jp/orthoped/research/
Publication of results
Unpublished
Result
URL related to results and publications
http://www.med.osaka-cu.ac.jp/orthoped/research/
Number of participants that the trial has enrolled
53
Results
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.
Results date posted
| 2020 | Year | 03 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
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.
Participant flow
Provide informed consent directly to the selected patients and have them give their consent in a written consent form.
Adverse events
This was a trial to discontinue the drug and no specific adverse events were reported.
Outcome measures
DAS28/CRP/ESR/USGS score/USPD score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2012 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 26 | Day |
Last modified on
| 2020 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012074
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