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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012005
Receipt No. 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

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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
Email 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
Email t-takeuchi@osaka-med.ac.jp

Sponsor
Institute Osaka Medical College
Institute
Department

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
Email 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
URL(English) https://upload.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


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