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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008889
Receipt No. R000010430
Official scientific title of the study Cohort study of infectious disease risk management in Rheumatoid Arthritis patients receiving tocilizumab
Date of disclosure of the study information 2012/09/10
Last modified on 2012/09/10

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Basic information
Official scientific title of the study Cohort study of infectious disease risk management in Rheumatoid Arthritis patients receiving tocilizumab
Title of the study (Brief title) Cohort study of infectious disease risk management in Rheumatoid Arthritis patients receiving tocilizumab (ACT4U-study)
Region
Japan

Condition
Condition Rheumatoid Arthritis
Classification by specialty
Medicine in general Clinical immunology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To validate the deterrence effect of infectious disease risk management (IDRM) in RA patients with tocilizumab.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Occurrence frequency of severe infection in RA patients with tocilizumab under the infectious disease risk management.
Key secondary outcomes Hospitalization for infectious disease and its duration.the reduction dose of disease-modifying antirheumatic drugs. Clinical composite activity indices at 24 and 48weeks (DAS28, CDAI, Boolean index). Persistence rate of tocilizumab at 48weeks

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)patients who fulfilled the American College R classification criteria.

2)RA patients administered tocilizumab for the first time between April 2009 and March 2011.
Key exclusion criteria Patients who had functional class4
Using Steinbrocker criteria
Target sample size 50

Research contact person
Name of lead principal investigator Yoshiaki Ishigatsubo
Organization Yokohama City University Graduate School of Medicine
Division name Dept. of Internal Medicine and Clinical Immunology
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City
TEL 045-787-2800
Email

Public contact
Name of contact person
Organization Yokohama City University Graduate School of Medicine
Division name Dept. of Internal Medicine and Clinical Immunology
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City
TEL
Homepage URL
Email

Sponsor
Institute Yokohama City University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Chugai pharmaceutical co. ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

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
2012 Year 09 Month 10 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2009 Year 05 Month 17 Day
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2013 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Prospective cohort study. PMS study in Japan was utilized as controls.
CD64 counts and procarcitonin were measured at baseline and the onset of infectious events.

Management information
Registered date
2012 Year 09 Month 10 Day
Last modified on
2012 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010430


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