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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024071
Receipt No. R000027613
Scientific Title Serious Infections after Tocilizumab Administration in Patients with Rheumatoid Arthritis: A Retrospective Study Using an Adverse Drug Reaction Database -Analysis of Clinical Symptoms and Laboratory Test Data in Serious Infections-
Date of disclosure of the study information 2016/09/16
Last modified on 2016/09/15

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Basic information
Public title Serious Infections after Tocilizumab Administration in Patients with Rheumatoid Arthritis: A Retrospective Study Using an Adverse Drug Reaction Database
-Analysis of Clinical Symptoms and Laboratory Test Data in Serious Infections-
Acronym Serious Infections after Tocilizumab Administration in Patients with Rheumatoid Arthritis: A Retrospective Study Using an Adverse Drug Reaction Database
-Analysis of Clinical Symptoms and Laboratory Test Data in Serious Infections-
Scientific Title Serious Infections after Tocilizumab Administration in Patients with Rheumatoid Arthritis: A Retrospective Study Using an Adverse Drug Reaction Database
-Analysis of Clinical Symptoms and Laboratory Test Data in Serious Infections-
Scientific Title:Acronym Serious Infections after Tocilizumab Administration in Patients with Rheumatoid Arthritis: A Retrospective Study Using an Adverse Drug Reaction Database
-Analysis of Clinical Symptoms and Laboratory Test Data in Serious Infections-
Region
Japan

Condition
Condition Rheumatoid Arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 An exploratory investigation of the progression to serious of infection after tocilizumab administration to patients with rheumatoid arthritis, and of the relationship between blood biochemistry values and clinical findings as prodromal symptoms.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To identify the initial symptoms before developing serious infection (SI) in the TCZ treated patients by using the clinical narratives from Post-marketing adverse events reporting database.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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 who developed serious infections for which a causal relationship could not be ruled out.
Key exclusion criteria None
Target sample size 7653

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshida,Shin
Organization CHUGAI PHARMACEUTICAL CO.,LTD.
Division name DRUG SAFTY DATA MANAGEMENT DEPT.
Zip code
Address 1-1 NIHONBASHI-MUROMACHI 2-CHOME,CHUO-KU TOKYO
TEL 03-3273-0938
Email yoshidasn@chugai-pharm.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ando,Yoshiaki
Organization CHUGAI PHARMACEUTICAL CO.,LTD.
Division name DRUG SAFTY DATA MANAGEMENT DEPT.
Zip code
Address 1-1 NIHONBASHI-MUROMACHI 2-CHOME,CHUO-KU TOKYO
TEL 03-3273-0938
Homepage URL
Email ando.yoshiaki20@chugai-pharm.co.jp

Sponsor
Institute CHUGAI PHARMACEUTICAL CO.,LTD.
DRUG SAFTY DATA MANAGEMENT DEPT.
Institute
Department

Funding Source
Organization CHUGAI PHARMACEUTICAL CO.,LTD.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor HOKKAIDO UNIVERSITY
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 09 Month 16 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 Completed
Date of protocol fixation
2016 Year 03 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2016 Year 09 Month 15 Day
Last modified on
2016 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027613

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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