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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011584
Receipt No. 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

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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
Email 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
Email mr.hirabayashi@gmail.com

Sponsor
Institute Hikarigaoka Spellman Hospital, Department of Rheumatology
Tohoku University Hospital, Department of
Hematology & Rheumatology
Institute
Department

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
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 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
URL(English) https://upload.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


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