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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002246
Receipt No. 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 2012/11/28

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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
Middle name
Last name Tatsuya Koike
Organization Osaka City University Medical School
Division name Rheumatosurgery
Zip code
Address Abenoku Asahimachi 1-4-3, Osaka, 545-8585, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka City University Medical School
Division name Rheumatosurgery
Zip code
Address
TEL
Homepage URL
Email tatsuya@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Medical School, Department of Rheumatosurgery
Institute
Department

Funding Source
Organization Department of Rheumatosurgery, Osaka City University Medical School
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
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
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
2012 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002732

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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