UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001240 |
|---|---|
| Receipt number | R000001513 |
| Scientific Title | The efficacy of tocilizumab to patients with rheumatoid arthritis refractory to anti-TNF agents: the open trial |
| Date of disclosure of the study information | 2008/07/10 |
| Last modified on | 2013/02/12 09:02:18 |
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Basic information
Public title
The efficacy of tocilizumab to patients with rheumatoid arthritis refractory to anti-TNF agents: the open trial
Acronym
The efficacy of tocilizumab to RA patients refractory to anti-TNF agents
Scientific Title
The efficacy of tocilizumab to patients with rheumatoid arthritis refractory to anti-TNF agents: the open trial
Scientific Title:Acronym
The efficacy of tocilizumab to RA patients refractory to anti-TNF agents
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the efficacy of tocilizumab to patients with rheumatoid arthritis refractory to anti-TNF agents
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DAS28 to be evaluated every 6 months for 3 years
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks for 3 years
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with 3.2 or more of DAS28-CRP 6 months after treatment with infliximab or etanercept are to be enrolled.
Key exclusion criteria
1. pregnant women or women trying to get pregnant
2. patients with dementia
3. patients considered inappropriate judged by attending physicians
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Iwamoto |
Organization
Jichi medical University
Division name
Division of Rheumatology & Clinical Immunology
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Jichi medical University
Division name
Division of Rheumatology & Clinical Immunology
Zip code
Address
TEL
Homepage URL
hiro-iwa@jichi.ac.jp
Sponsor or person
Institute
Division of Rheumatology & Clinical Immunology, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2008 | Year | 07 | 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
Completed
Date of protocol fixation
| 2008 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We lost the novelty of results because of several papers with same purpose published.
Management information
Registered date
| 2008 | Year | 07 | Month | 10 | Day |
Last modified on
| 2013 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001513
