UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012005 |
|---|---|
| Receipt number | R000014026 |
| Scientific Title | Identification of Bio-Markers Predicting the Therapeutic Effects of Tocilizumab in Rheumatoid Arthritis |
| Date of disclosure of the study information | 2013/10/09 |
| Last modified on | 2021/04/19 13:35:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Identification of Bio-Markers Predicting the Therapeutic Effects of Tocilizumab in Rheumatoid Arthritis
Acronym
Identification of Bio-Markers Predicting the Therapeutic Effects of Tocilizumab in Rheumatoid Arthritis
Scientific Title
Identification of Bio-Markers Predicting the Therapeutic Effects of Tocilizumab in Rheumatoid Arthritis
Scientific Title:Acronym
Identification of Bio-Markers Predicting the Therapeutic Effects of Tocilizumab in Rheumatoid Arthritis
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the relation between the change of serum biomarkers and the therapeutic effects of tocilizumab and identify new biomarkers predicting its effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The therapeutic effects 52 weeks after the initiation of tocilizumab
Key secondary outcomes
Biomarkers such as c-reactive protein, matrix metalloproteinase, cytokines before and after tocilizumab therapy
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients refractory to conventinal therapies for rheumatoid arthritis
Key exclusion criteria
Patients with interstitial pneumonia or renal dysfunction
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Makino |
Organization
Osaka Medical College
Division name
Department of Internal Medicine (I)
Zip code
569-8686
Address
Daigaku-machi 2-7, Takatsuki, Osaka
TEL
072-683-1221
t-takeuchi@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | Tohru |
| Middle name | |
| Last name | Takeuchi |
Organization
Osaka Medical College
Division name
Department of Internal Medicine (I)
Zip code
569-8686
Address
Daigaku-machi 2-7, Takatsuki, Osaka
TEL
072-683-1221
Homepage URL
t-takeuchi@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Takatsuki Red Cross Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee
Address
Daigaku-machi 2-7, Takatsuki, Osaka
Tel
072-683-1221
rinri@art.osaka-med.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 | 10 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We assess the therapeutic effect 52 weeks after tocilizumab therapy. Patients were divided to two groups (responders and non-responders) based on the therapeutic effect. We compare the serum biomarkers between responders and non-responders.
Management information
Registered date
| 2013 | Year | 10 | Month | 09 | Day |
Last modified on
| 2021 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014026
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
