UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017947 |
|---|---|
| Receipt number | R000020721 |
| Scientific Title | Efficacy and change of serum IL-6 levels in patients with rheumatoid arthritis treated with tocilizumab |
| Date of disclosure of the study information | 2015/06/21 |
| Last modified on | 2015/06/17 15:45:01 |
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Basic information
Public title
Efficacy and change of serum IL-6 levels in patients with rheumatoid arthritis treated with tocilizumab
Acronym
Efficacy and serum IL-6 in RA treated with tocilizumab
Scientific Title
Efficacy and change of serum IL-6 levels in patients with rheumatoid arthritis treated with tocilizumab
Scientific Title:Acronym
Efficacy and serum IL-6 in RA treated with tocilizumab
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine efficacy and serum IL-6 levels in patients with rheumatoid arthritis treated with tocilizumab
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Remission rate at 24 weeks.
Change of serum IL-6 levels at 24 weeks and 52 weeks
Key secondary outcomes
Remission rate at 12 weeks and 52 weeks
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with RA who met the 1987 revised criteria of ACR or the 2010 ACR/EULAR classification criteria.
Patients with active RA who had been treated with at least one biologics.
Key exclusion criteria
Patients who corresponds to a contraindication of tocilizumab
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Tada |
Organization
Saga University hospital
Division name
Department of Rheumatology
Zip code
Address
5-1-1 Nabeshima, Saga
TEL
0952-34-2367
taday@cc.saga-u.ac.p
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshifumi Tada |
Organization
Saga University
Division name
Department of Rheumatology
Zip code
Address
5-1-1 Nabeshima, Saga
TEL
0952-34-2367
Homepage URL
taday@cc.saga-u.ac.jp
Sponsor or person
Institute
Department of Rheumatology, Saga University
Institute
Department
Personal name
Funding Source
Organization
Saga University
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
| 2015 | Year | 06 | Month | 21 | 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 | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | 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
Undetermined
Management information
Registered date
| 2015 | Year | 06 | Month | 17 | Day |
Last modified on
| 2015 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020721
