UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010647 |
|---|---|
| Receipt number | 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 08:18:58 |
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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
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
Sponsor or person
Institute
Nagoya Medical Center National Hospital Organization in Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012450
| 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 |
