UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032316 |
|---|---|
| Receipt number | R000036857 |
| Scientific Title | Serum predictive cytokine validation in Rheumatoid Arthritis to withdraw Orencia by using ultrasound analysis |
| Date of disclosure of the study information | 2018/04/19 |
| Last modified on | 2023/04/23 15:08:26 |
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Basic information
Public title
Serum predictive cytokine validation in Rheumatoid Arthritis to withdraw Orencia by using ultrasound analysis
Acronym
SOROBAN study
Scientific Title
Serum predictive cytokine validation in Rheumatoid Arthritis to withdraw Orencia by using ultrasound analysis
Scientific Title:Acronym
SOROBAN study
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is intended to validate the therapeutic efficacy and safety of Abatacept (ABT) to RA patients who do not achieve the power Doppler remission of Ultrasound (Ultrasound Image remission <USIR>) during the first treatment of DMARDs for 3 months. Additionally, the possibility of withdrawal of ABT treatment is also examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The remission rate of DAS, SDAI, CDAI, Boolean, mHAQ and USIR at Week 24
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients aged >=18 years old at the time of informed consent
2)Patients who met the 2010 ACR/EULAR criteria
3)Previously untreated with JAK inhibitor or Biologics at the time of informed consent
4)Treatment naive early RA patients (duration<6 months) who do not achieve USIR during the first treatment of DMARDs for 3 months.
5)Patient who can fully understand the protocol and voluntarily consent in writing to participate in this study.(In the case of patients under 20 years old, we also obtain consent from parents)
Key exclusion criteria
1) Current complication of malignant tumor
2) severe infection including active tuberculosis
3) ongoing or history of demyelinating disease
4) congestive heart disease
5) previous treatment with glucocorticoid, DMARDs and biologics
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kenta |
| Middle name | |
| Last name | Misaki |
Organization
Kita-Harima Medical Center
Division name
Rheumatology
Zip code
675-1392
Address
926-250 Ichiba-cho, Ono city, Hyogo pref. JAPAN
TEL
0794-88-8800
kenta_misaki@kitahari-mc.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Misaki |
Organization
Kita-Harima Medical Center
Division name
Rheumatology
Zip code
675-1392
Address
926-250 Ichiba-cho, Ono city, Hyogo pref. JAPAN
TEL
0794-88-8800
Homepage URL
kenta_misaki@kitahari-mc.jp
Sponsor or person
Institute
Kita-Harima Medical Center
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co.,LTD. / Bristol-Myers Squibb Co.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kita-Harima Medical center
Address
as same above
Tel
0794-88-8800
kenta_misaki@kitahari-mc.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
| 2018 | Year | 04 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 04 | Month | 19 | Day |
Last modified on
| 2023 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036857
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
