UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008185 |
|---|---|
| Receipt number | R000009646 |
| Scientific Title | Pilot study on the efficacy and safty of low-dose tocilizumab therapy in elderly RA patients |
| Date of disclosure of the study information | 2012/06/25 |
| Last modified on | 2012/06/16 17:31:15 |
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Basic information
Public title
Pilot study on the efficacy and safty of low-dose tocilizumab therapy in elderly RA patients
Acronym
Pilot study on low-dose tocilizumab therapy in elderly RA patients
Scientific Title
Pilot study on the efficacy and safty of low-dose tocilizumab therapy in elderly RA patients
Scientific Title:Acronym
Pilot study on low-dose tocilizumab therapy in elderly RA patients
Region
| Japan |
Condition
Condition
Rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the efficacy and safty of low-dose tocilizumab (4mg/kgBW) in elderly RA patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
number of patients who effectively completed the low-dose tocilizumab (4mg/kgBW) therapy until 24 weeks after initiation
Key secondary outcomes
Change of DAS28-ESR, CDAI, SDAI, CRP and ESR before and 24 weeks after tocilizumab therapy
adverse effects
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
RA patients who are 65 years old or more will be enrolled after informed concent is taken. Candidates should be under the treatment in Kyushu University Beppu Hospital, Beppu, Japan. The patients should fulfill the ACR RA criteria 1987. DAS28-ESR should be more than 3.2 for past 3 months even after being treated with DMARDs or anti-TNF therapy.
Key exclusion criteria
Pateints whose RA stage is Steinbroker IV.
Patients who have ever been treated with tocilizumab.
Patients who are given 10mg or more PSL daily within 4 weeks.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichiro Ikuyama |
Organization
Kyushu University Beppu Hospital
Division name
Department of Metabolism, Hematology and Rheumatic Diseases (DMHRDs)
Zip code
Address
4546 Tsurumihara, Beppu 874-0838, Japan
TEL
0977-27-1640
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
DMHRDs
Division name
DMHRDs
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kyushu University Beppu Hospital
Department of Metabolism, Hematology and Rheumatic Diseases (DMHRDs)
Institute
Department
Personal name
Funding Source
Organization
self-funding
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
| 2012 | Year | 06 | Month | 25 | 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
| 2012 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | 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
Management information
Registered date
| 2012 | Year | 06 | Month | 16 | Day |
Last modified on
| 2012 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009646
