UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011584 |
|---|---|
| Receipt number | R000013546 |
| Scientific Title | A longitudinal, prospective, multicenter observational study in patients with rheumatoid arthritis receiving tocilizumab |
| Date of disclosure of the study information | 2013/08/27 |
| Last modified on | 2017/02/27 11:08:37 |
* 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
A longitudinal, prospective, multicenter observational study in patients with rheumatoid arthritis receiving tocilizumab
Acronym
Michinoku tocilizumab study
Scientific Title
A longitudinal, prospective, multicenter observational study in patients with rheumatoid arthritis receiving tocilizumab
Scientific Title:Acronym
Michinoku tocilizumab study
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long-term efficacy and safety of tocilizumab in real clinical practice
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DAS28ESR, CRP, adverse effect, persistency
Key secondary outcomes
WBC, RBC, Hb, PLT, AST, ALT, Cr, Total-cho, TG, HDL-cho, MMP-3, joint roentgenogram
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
The patients with rheumatoid arthritis receiving tocilizumab
Key exclusion criteria
Not applicable
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Hirabayashi |
Organization
Hikarigaoka Spellman Hospital
Division name
Department of Rheumatology
Zip code
Address
6-7-1 Higashisendai, Miyagino-ku, Sendai, Miyagi, Japan
TEL
022-257-0231
mr.hirabayashi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Hirabayashi |
Organization
Hikarigaoka Spellman Hospital
Division name
Department of Rheumatology
Zip code
Address
6-7-1 Higashisendai, Miyagino-ku, Sendai, Miyagi, Japan
TEL
022-257-0231
Homepage URL
mr.hirabayashi@gmail.com
Sponsor or person
Institute
Hikarigaoka Spellman Hospital, Department of Rheumatology
Tohoku University Hospital, Department of
Hematology & Rheumatology
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Hospital, Department of
Hematology & Rheumatology
Hikarigaoka Spellman Hospital, Department of Rheumatology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ichinohasama Memorial READ Blood Academy
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 | 08 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.tandfonline.com/doi/full/10.3109/14397595.2016.1160991
Number of participants that the trial has enrolled
Results
(1) Clinical Rheumatology
2013, Volume 32, Issue 1, pp 123-127.
The DAS28-ESR cutoff value necessary to achieve remission under the new Booleanbased remission criteria in patients receiving tocilizumab
(2) Modern Rheumatology
2016, Volume 26, Issue 6, pp 828-835.
Clinical and structural remission rates increased annually and radiographic
progression was continuously inhibited during a 3-year administration of
tocilizumab in patients with rheumatoid arthritis: A multi-center, prospective
cohort study by the Michinoku Tocilizumab Study Group
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
Completed
Date of protocol fixation
| 2010 | Year | 02 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 11 | Month | 19 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 04 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 17 | Day |
Other
Other related information
Main outcome measures:
DAS28ESR, CRP, adverse effect, persistency
Secondary outcome measures:
WBC, RBC, Hb, PLT, AST, ALT, Cr, Total-cho, TG, HDL-cho, MMP-3, joint roentgenogram
Management information
Registered date
| 2013 | Year | 08 | Month | 26 | Day |
Last modified on
| 2017 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013546
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/02/27 | 20100117 TCZ長期観察調査実施計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2017/02/27 | 20100224 調査票ver2.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2017/02/27 | 20150604 DC036_Dataset固定.xlsx |
