UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002843 |
|---|---|
| Receipt number | 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 20:42:55 |
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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
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
ferogradumet@yahoo.co.jp
Sponsor or person
Institute
Division of Rheumatology, Department of Internal Medicine, Kanazawa 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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003369
