UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016298 |
|---|---|
| Receipt number | R000018909 |
| Scientific Title | Non-interventional retrospective observation study for pretretment prediction of rheumatoid arthritis patients' response to anti-cytokine therapy using serum cytokine / chemkine / soluble receptor biomarkers |
| Date of disclosure of the study information | 2015/01/21 |
| Last modified on | 2015/01/23 16:15:23 |
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Basic information
Public title
Non-interventional retrospective observation study for pretretment prediction of rheumatoid arthritis patients' response to anti-cytokine therapy using serum cytokine / chemkine / soluble receptor biomarkers
Acronym
Retrospective observation study for prediction of response in RA before anti-cytokine therapy
Scientific Title
Non-interventional retrospective observation study for pretretment prediction of rheumatoid arthritis patients' response to anti-cytokine therapy using serum cytokine / chemkine / soluble receptor biomarkers
Scientific Title:Acronym
Retrospective observation study for prediction of response in RA before anti-cytokine therapy
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Selection of biomarkers in pretreatment serum which predicts the therapeutic response
Basic objectives2
Others
Basic objectives -Others
Personal response to the therapy is able to predict using the selected biomarkers
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
A patient can select an effective therapeutic reagent indivisually
Key secondary outcomes
A patient predicts the clinical response before therapy using pretreatment biomarkes in serum
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Rheumatoid arthritis (RA) who failed prior methotrexate treatment.
They are treated with Tocilizumab or Etanercept over 16 weeks
Key exclusion criteria
RA patients treated with Tocilizumab or Etanercept within 16 weeks
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Yoshizaki |
Organization
Osaka University
Division name
Graduate School of Engineering
Zip code
Address
6-2-3 Furuedai, Suita, Osaka
TEL
06-6872-7460
kyoshi@chem.eng.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuyuki Yoshizaki |
Organization
Osaka University
Division name
Graduate School of Engineering
Zip code
Address
6-2-3 Furuedai, Suita, Osaka
TEL
06-6872-7460
Homepage URL
kyoshi@chem.eng.osaka-u.ac.jp
Sponsor or person
Institute
Graduate School of Engineering,Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東広島記念病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 21 | 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
In this observational and non-interventional retrospective cohort study, we measured 31 cytokines/chemokines/soluble receptors in 138 RA patients pre-treatment serum. Patients (naive and non-naive to anti-cytokine therapy) were administered tocilizumab or etanercept therapy, between 2008 and 2013, and using this data, we selected and identified biomarkers that correlated with patients symptom levels (DAS28CRP score) 16 weeks after their treatment began using multiple linear regression analysis and biomarkers that correlated with patients final outcome using multiple logistic analysis. The results revealed that sgp130 and other seven factors serum levels before tocilizumab therapy were potential biomarkers to predict naive patients week 16 DAS-CRP score. On the other hand, sgp130 and other two factors were predictive biomarkers for non-naive patients. Additionally, logIL-9 and other two factors were found to be less reliable biomarkers to predict the week 16 DAS28-CRP score in naive patients treated with etanercept.
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
Completed
Date of protocol fixation
| 2009 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 20 | Day |
Last follow-up date
| 2012 | Year | 08 | Month | 18 | Day |
Date of closure to data entry
| 2012 | Year | 12 | Month | 11 | Day |
Date trial data considered complete
| 2013 | Year | 06 | Month | 26 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 01 | Day |
Other
Other related information
Since this study is confirmed as a non-interventional retrospective observation study and the prediction markers for therapeutic response are detected, the study title, correlation of pre-treatment cytokine profile of the RA patient and the therapeutic response to biologics, at the judgment of the ethical committee is changed to the title at UMIN registration.
We discovered highly reliable biomarkers in RA serum that could predict their week 16 DAS28-CRP score and clinical outcome before they underwent tocilizumab therapy. Although less reliable than those for tocilizumab, we identified a few possible biomarkers for etanercept therapy. The predictive biomarkers for these two therapies differ which means their suitability will vary for individual patients. Most of the predictive biomarkers identified for tocilizumab, especially sgp130, are involved in RA pathogenesis, which further suggests that they are highly reliable.
Management information
Registered date
| 2015 | Year | 01 | Month | 21 | Day |
Last modified on
| 2015 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018909
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