UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036601 |
|---|---|
| Receipt number | R000041693 |
| Scientific Title | ShorT spAce or incRease dosage of Biologics for rheumatoid arthritis patients with subclinical synOvitis detected by ultrAsound suppRess joint Destruction |
| Date of disclosure of the study information | 2019/05/07 |
| Last modified on | 2024/04/30 17:02:01 |
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Basic information
Public title
ShorT spAce or incRease dosage of Biologics for rheumatoid arthritis patients with subclinical synOvitis detected by ultrAsound suppRess joint Destruction
Acronym
STARBOARD study
Scientific Title
ShorT spAce or incRease dosage of Biologics for rheumatoid arthritis patients with subclinical synOvitis detected by ultrAsound suppRess joint Destruction
Scientific Title:Acronym
STARBOARD study
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is aimed to evaluate the efficacy on disease activity or joint destruction by strengthening treatment among RA patients treated by biologics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change in radiographical joint destruction or Power Doppler signal by ultrasound assessment
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
RA patients who fulfill ACR/EULAR criteria and come to see our institution
Patients using biologic agents including infliximab, golimumab and tocilizumab
Key exclusion criteria
Those who declined enrollment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Okano |
| Middle name | |
| Last name | Tadashi |
Organization
Osaka city university, School of medicine
Division name
Department of orthopedics
Zip code
545-8585
Address
1-4-3 Asahimachi, Abeno-ku Osaka city
TEL
0666453851
ma1sa3ru@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Okano |
| Middle name | |
| Last name | Tadashi |
Organization
Osaka city university, School of medicine
Division name
Department of orthopedics
Zip code
545-8585
Address
1-4-3 Asahimachi, Abeno-ku Osaka city
TEL
0666453851
Homepage URL
ma1sa3ru@yahoo.co.jp
Sponsor or person
Institute
Osaka city university, School of medicine
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka city university, School of medicine
Address
1-4-3 Asahimachi, Abeno-ku Osaka city
Tel
06-6645-3456
irb@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
| 2019 | Year | 05 | Month | 07 | Day |
Related information
URL releasing protocol
https://ard.bmj.com/content/81/Suppl_1/1294.2
Publication of results
Unpublished
Result
URL related to results and publications
https://ard.bmj.com/content/81/Suppl_1/1294.2
Number of participants that the trial has enrolled
40
Results
There were 9 patients in PD>2/ET+ group and 31 patients in PD<2 group. PD>2/ET+ group had significantly higher SDAI (p=0.027), MMP-3 (p=0.005), and PD (p<0.001) at baseline compared with PD<2 group, but their MMP-3 (p=0.019) and PD (p=0.042) were significantly decreased over 1 year. PD>2/ET+ group had joint destruction before ET (p=0.022), but it was suppressed after ET and there was no significance in change in mTSS compared with PD<2 group (p>0.99) (Figure 1).
Results date posted
| 2024 | Year | 04 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Forty RA patients treated with standard dose of infliximab, tocilizumab or golimumab
Participant flow
Forty RA patients treated with standard dose of infliximab, tocilizumab or golimumab were included in this study. Ultrasound examination was performed at the bilateral first to fifth metacarpophalangeal joints, first interphalangeal (IP) and second to fifth proximal interphalangeal joints, wrist joints (three parts of radial, medial and ulnar) and first to fifth metatarsophalangeal joints, by using HI VISION Ascendus with a multifrequency linear transducer (18-6 MHz). Residual synovitis was defined as Power Doppler score (PD) >2. In patients with residual synovitis, we recommended enhanced treatment. The patients were divided into 3 groups, PD>2/ET+ group (patients agreed enhanced treatment), PD>2/ET- group (patients rejected enhanced treatment), and PD<2 group.
Adverse events
N/A
Outcome measures
We assessed ultrasound (PD score), laboratory data (CRP, MMP-3), disease activity (Simplified Disease Activity Index; SDAI), physical function (Health Assessment Questionnaire; HAQ), and joint destruction (modified Total Sharp Score; mTSS) at baseline and 1-year follow-up.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will end after ultrasound and X-ray examination at a year after enrollment
Management information
Registered date
| 2019 | Year | 04 | Month | 25 | Day |
Last modified on
| 2024 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041693
