UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006956 |
|---|---|
| Receipt number | R000008214 |
| Scientific Title | Efficacy and safety of tocilizumab in RA patients in daily clinical practice: An retrospective observational study |
| Date of disclosure of the study information | 2011/12/27 |
| Last modified on | 2019/07/02 13:57:02 |
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Basic information
Public title
Efficacy and safety of tocilizumab in RA patients in daily clinical practice: An retrospective observational study
Acronym
REtrospective ACTemra Investigation for Optimal Needs of RA patients study
Scientific Title
Efficacy and safety of tocilizumab in RA patients in daily clinical practice: An retrospective observational study
Scientific Title:Acronym
REtrospective ACTemra Investigation for Optimal Needs of RA patients study
Region
| Japan |
Condition
Condition
Rheumatoid Arthritis
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of achievement of clinical, structural and functional remission and the possibility of maintenance with tocilizumab in daily clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentages of three different remissions; clinical remission (the disease activity score using the 28 joint count [DAS28]-ESR<2.6), structural remission (modified total Sharp score [mTSS]=/<0.5), and functional remission (health assessment questionnaire [HAQ]=/<0.5) at week 104 after tocilizumab treatment.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)RA patients who fulfilled the ACR classification criteria.
2)RA patients administered tocilizumab for the first time between April 2008 and March 2009.
Key exclusion criteria
Patients who had functional class4 using Steinbrocker criteria.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Yoshiya |
| Middle name | |
| Last name | Tanaka |
Organization
University of Occupational and Environmental Health, Japan
Division name
The First Department of Internal Medicine, School of Medicine
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi, Kitakyushu, Japan
TEL
093-603-1611
tanaka@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | KAZUHISA |
| Middle name | |
| Last name | NAKANO |
Organization
University of Occupational and Environmental Health, Japan
Division name
The First Department of Internal Medicine, School of Medicine
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishiku
TEL
0936031611
Homepage URL
kazuhisa@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
Research Grant-In-Aid for Scientific Research from the Ministry of Health, Labor and Welfare of Japan (partly), Self funding
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Keio University, Tokyo Women's Medical University, Saitama Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Medical Research,University of Occupational and Environmental Health,Japan
Address
1-1 Iseigaoka, Yahatanishiku, Kitakyushu
Tel
093-603-1611
daigakukanri@mbox.pub.uoeh-u.ac.jp
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
産業医科大学・東京女子医科大学附属膠原病リウマチ痛風センター・埼玉医科大学病院総合医療センター・慶應義塾大学医学部内科学教室
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | 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
Percentages of three different remissions; clinical remission (DAS28-ESR<2.6), structural remission (mTSS≤0.5), and functional remission (HAQ≤0.5) at week 104 after tocilizumab treatment.
Management information
Registered date
| 2011 | Year | 12 | Month | 26 | Day |
Last modified on
| 2019 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008214
