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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002843
Receipt No. R000003369
Scientific Title The efficacy and safety of tocilizumab (trade name: Actemra) in RA patients.
Date of disclosure of the study information 2010/01/01
Last modified on 2009/12/03

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Basic information
Public title The efficacy and safety of tocilizumab (trade name: Actemra) in RA patients.
Acronym The efficacy and safety of tocilizumab (trade name: Actemra) in RA patients.
Scientific Title The efficacy and safety of tocilizumab (trade name: Actemra) in RA patients.
Scientific Title:Acronym The efficacy and safety of tocilizumab (trade name: Actemra) in RA patients.
Region
Japan

Condition
Condition Rhumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of tocilizumab (trade name: Actemra) in RA patients who have an inadequate response to DMARDs (including MTX) and TNF blockers, use IL-6 to verify whether early prediction of signs of infection during treatment is possible and investigate an appropriate IL-6 cut-off value at the onset of infection.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes An appropriate IL-6 cut-off value will be determined by comparing the difference of serum IL-6 concentrations between patients that developed infection and patients that did not develop infection.
Key secondary outcomes

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
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients at least 20 years old at enrolment
2) Patients diagnosed with RA based on the 1987 classification criteria of the American College of Rheumatology (ACR)
3) Patients who have had an inadequate response to at least one DMARD (including MTX)
4) Patients who have expressed their informed consent in writing
Key exclusion criteria 1) Patients with a history of sensitivity to any of the ingredients of Actemra
2) Patients with a serious concomitant infection
3) Patients with active tuberculosis
4) Patients with a lymphocyte count less than 500/ mcL
5) Patients with HCV, HBV or HIV infections
6) Other patients whom the investigator considers to be unsuitable for the study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motohiko Aizu
Organization Division of cardiovascular medicine,Kanazawa University Graduate School of Medicine
Division name Division of Rheumatology, Department of Internal Medicine
Zip code
Address 13-1 Takara-machi,Kanazawa-shi,Ishikawa-ken
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Division of cardiovascular medicine,Kanazawa University Graduate School of Medicine
Division name Division of Rheumatology, Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email ferogradumet@yahoo.co.jp

Sponsor
Institute Division of Rheumatology, Department of Internal Medicine, Kanazawa University Graduate School of Medicine
Institute
Department

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
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
2010 Year 01 Month 01 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 Enrolling by invitation
Date of protocol fixation
2009 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Nothing.

Management information
Registered date
2009 Year 12 Month 03 Day
Last modified on
2009 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003369

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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