UMIN-CTR Clinical Trial

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
Email	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
Email	tatsuya@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University Medical School, Center for Senile Degerative Disorders (CSDD)
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002732