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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010315
Receipt No. 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

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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
Email 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
Email ma1sa3ru@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Medical School
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012074

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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