UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006914 |
|---|---|
| Receipt number | R000008172 |
| Scientific Title | postmarketing surveillance For Investigating success in achieving clinical and functional Remission and Sustaining efficacy with Tocilizumab in BIOlogics naive RA patients |
| Date of disclosure of the study information | 2011/12/22 |
| Last modified on | 2018/01/22 11:18:50 |
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Basic information
Public title
postmarketing surveillance For Investigating success in achieving clinical and functional Remission and Sustaining efficacy with Tocilizumab in BIOlogics naive RA patients
Acronym
FIRST-BIO study
Scientific Title
postmarketing surveillance For Investigating success in achieving clinical and functional Remission and Sustaining efficacy with Tocilizumab in BIOlogics naive RA patients
Scientific Title:Acronym
FIRST-BIO study
Region
| Japan |
Condition
Condition
Patients with rheumatoid arthritis who have been diagnosed based on the 2010 ACR/EULAR new classification criteria for RA
Patients who have no previous medical history of biological agents for RA
Patients whose disease activity is DAS28>=3.2 at baseline
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the benefit of tocilizumab (TCZ) in the early diagnosed, biologics therapy naive patients in the real clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of patients achieving remission by the new ACR/EULAR Boolean based criteria at week 52. (Comparing the remission rate by disease duration)
Key secondary outcomes
Adverse reaction incidence
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Rheumatoid arthritis diagnosed by ACR/EULAR new classification criteria for RA.
Biological drug treatment naive.
Moderate to high disease activity (DAS28>=3.2) at baseline.
Key exclusion criteria
No criteria
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Joji Mochizuki |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Pharmacovigilance Dept.
Zip code
Address
1-1 Muromachi 2-Chome, Chuo-ku Tokyo, JAPAN
TEL
03-3273-0905
mochizukijuj@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Nomura |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Pharmacovigilance Dept.
Zip code
Address
1-1 Muromachi 2-Chome, Chuo-ku Tokyo, JAPAN
TEL
03-3273-0905
Homepage URL
nomuramkt@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co. Ltd.
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
| 2011 | Year | 12 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 11 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 29 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 29 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 11 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 23 | Day |
Other
Other related information
Tender joint count, Swollen joint count, Patient global assessment on VAS, Physician global assessment on VAS, ESR, C-reactive protein and Rheumatoid factor, HAQ
Management information
Registered date
| 2011 | Year | 12 | Month | 20 | Day |
Last modified on
| 2018 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008172
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
