UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008889 |
|---|---|
| Receipt number | R000010430 |
| Scientific Title | 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 19:53:59 |
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Basic information
Public title
Cohort study of infectious disease risk management in Rheumatoid Arthritis patients receiving tocilizumab
Acronym
Cohort study of infectious disease risk management in Rheumatoid Arthritis patients receiving tocilizumab (ACT4U-study)
Scientific Title
Cohort study of infectious disease risk management in Rheumatoid Arthritis patients receiving tocilizumab
Scientific Title:Acronym
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
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
| 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
| 1st name | |
| Middle name | |
| Last name | Yoshiaki Ishigatsubo |
Organization
Yokohama City University Graduate School of Medicine
Division name
Dept. of Internal Medicine and Clinical Immunology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City
TEL
045-787-2800
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yokohama City University Graduate School of Medicine
Division name
Dept. of Internal Medicine and Clinical Immunology
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama City
TEL
Homepage URL
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
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)
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
| 2012 | Year | 09 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 05 | Month | 17 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010430
