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

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 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


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

Value
https://center6.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