UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010647
Receipt No. R000012450
Scientific Title To investigate weather the concentration of baseline serum cytokines can become the predictor of treatment response of tocilizimab.
Date of disclosure of the study information 2013/05/04
Last modified on 2013/05/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title To investigate weather the concentration of baseline serum cytokines can become the predictor of treatment response of tocilizimab.
Acronym PREDICT-TCZ study
Scientific Title To investigate weather the concentration of baseline serum cytokines can become the predictor of treatment response of tocilizimab.
Scientific Title:Acronym PREDICT-TCZ study
Region
Japan

Condition
Condition Rheumatoid Arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect that IL-6 inhibition gives to the immune system in RA.
To investigate whether the concentration of various cytokines at baseline can become the predictive factor of the efficacy of tocilizumab at 24 weeks.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between the concentration of various kinds of serum cytokine at 24 weeks and CDAI at 24 weeks
Key secondary outcomes 1.Correlation between the concentration of various kinds of serum cytokine and clinical remission assessed by CDAI at 24 weeks
2.Correlation between the concentration of various kinds of serum cytokine and the joints damage at 52 weeks
3.Change of DAS28ESR(4),CDAI and Simplified Disease Activity Score(SDAI) from baseline for every 4 weeks Remission rate assessed by SDAI,CDAI,DAS28ESR(4) and ACR/EULAR Boolean based criteria
4.Any adverse events

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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1)Patients between 20 and 90 years old
2)Patients with rheumatoid arthritis
3)Patients with low to moderate activity
4)Patient is going to give tocilizumab
5)The patient by whom consent is got in written form about participation of the final examination
Key exclusion criteria 1)Patients who have serious infection
2)Patients who have history of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
3)Patients who have history of a malignant tumor or who have malignant tumor
4)Patients who have serious cardiac disease or liver disease, renal damage
5)Pregnant women or women trying to get pregnant
6)Patients considered inappropriate judged by attending physicians
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisato Ishikawa
Organization Nagoya Medical Center National Hospital Organization in Japan
Division name Department of Orthopaedic Surgery and Rheumatology
Zip code
Address 4-1-1 Sannomaru,Naka-ku Nagoya Aichi 460-0001, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Nagoya Medical Center National Hospital Organization in Japan
Division name Department of Orthopaedic Surgery and Rheumatology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Nagoya Medical Center National Hospital Organization in Japan
Institute
Department

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
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
2013 Year 05 Month 04 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 Enrolling by invitation
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To investigate the effect that IL-6 inhibition gives to the immune system in RA.
To investigate whether the concentration of various cytokines at baseline can become the predictive factor of the efficacy of tocilizumab at 24 weeks.

Management information
Registered date
2013 Year 05 Month 04 Day
Last modified on
2013 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012450

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.