UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024071 |
|---|---|
| Receipt number | 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 19:54:50 |
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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
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
ando.yoshiaki20@chugai-pharm.co.jp
Sponsor or person
Institute
CHUGAI PHARMACEUTICAL CO.,LTD.
DRUG SAFTY DATA MANAGEMENT DEPT.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027613
