UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002246 |
|---|---|
| Receipt number | R000002732 |
| Scientific Title | Study for Predictors of Effectiveness in Tocilizumab Therapy (PETITE) |
| Date of disclosure of the study information | 2009/08/01 |
| Last modified on | 2022/02/01 18:36:40 |
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Basic information
Public title
Study for Predictors of Effectiveness in Tocilizumab Therapy (PETITE)
Acronym
PETITE study
Scientific Title
Study for Predictors of Effectiveness in Tocilizumab Therapy (PETITE)
Scientific Title:Acronym
PETITE study
Region
| Japan |
Condition
Condition
rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To detect unknown factors that can predict the effects of tocilizumab in rheumatoid arthritis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
DAS28 and CDAI at 12 week after the start of tocilizumab therapy
Key secondary outcomes
DAS28 and CDAI at 28 week after the start of tocilizumab therapy
Adverse event
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
| 16 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who were resistant for DMARDs (including MTX)
or anti-TNF biologics therapy, and then will receive tocilizumab therapy
Key exclusion criteria
Patients who received tocilizumab therapy previously
Patients who received steroid newly, dose-up of steroid, plasma exchange or artificial joint replacements within 4 weeks before tocilizumab treatment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Koike |
Organization
Osaka City University Medical School
Division name
Center for Senile Degerative Disorders (CSDD)
Zip code
545-8585
Address
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL
06-6646-6010
tatsuya@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | tatsuya |
| Middle name | |
| Last name | Koike |
Organization
Osaka City University Medical School
Division name
Center for Senile Degerative Disorders (CSDD)
Zip code
545-8585
Address
Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL
6+6646-6010
Homepage URL
tatsuya@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Medical School, Center for Senile Degerative Disorders (CSDD)
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Medical School, Center for Senile Degerative Disorders (CSDD)
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
Clinical Research Review Board, Osaka City University Hospital
Address
Abenoku asahimachi 1-5-7, Osaka, Japan
Tel
06-6645-3457
ethics@med.osaka-cu.ac.jp
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
| 2009 | Year | 08 | 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
No longer recruiting
Date of protocol fixation
| 2009 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In the treatment of rheumatoid arthritis, tocilizumab is recognized that the effect is clinically slow among biologics. However, the factor that can be forecast beforehand doesn't turn out. Then, the information gathering of the factor in the baseline including the IL-1 measurement is done, and the effect forecast factor is identified based on the effect judgment done at 12 weeks.
Management information
Registered date
| 2009 | Year | 07 | Month | 24 | Day |
Last modified on
| 2022 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002732
