UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008404 |
|---|---|
| Receipt number | R000009886 |
| Scientific Title | Extension of Tocilizumab Dose Intervals in Patients with Low to Moderate Disease Activity Rheumatoid Arthritis using IL-6 Serum Level as Starting Criteria. |
| Date of disclosure of the study information | 2012/07/12 |
| Last modified on | 2015/07/11 23:13:33 |
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Basic information
Public title
Extension of Tocilizumab Dose Intervals in Patients with Low to Moderate Disease Activity Rheumatoid Arthritis using IL-6 Serum Level as Starting Criteria.
Acronym
Extension of Tocilizumab Dose Intervals in Patients with Rheumatoid Arthritis using IL-6 Serum Level Criteria.
Scientific Title
Extension of Tocilizumab Dose Intervals in Patients with Low to Moderate Disease Activity Rheumatoid Arthritis using IL-6 Serum Level as Starting Criteria.
Scientific Title:Acronym
Extension of Tocilizumab Dose Intervals in Patients with Rheumatoid Arthritis using IL-6 Serum Level Criteria.
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Medicine in general | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate extension of tocilizumab dose intervals from 4 to 8 weeks as a maintenance therapy using IL-6 serum level starting criteria
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of patients completed 48 weeks with tocilizumab 8-weeks dose intervals.
Key secondary outcomes
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
Extension of Tocilizumab Dose Intervals
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Rheumatoid arthritis diagnosed by ACR/EULAR new classification criteria for RA.
2) Patients diagnosed as low disease activity state of RA (CDAI10 or less)
3) Patients with IL-6 serum concentration(35 pg/mL or less)
Key exclusion criteria
1) Patient who has no contraindications to methotrexate or to tocilizumab.
2) Patients who are inadequate to enter this trail due to the other reasons by physicians judgments.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | 1) Yasuhiko Kita 2) Hiroyuki Hagiyama |
Organization
1) Japan Labour Health and Welfare Organization,Yokohama Rosai Hospital
2) Yokohama City Minato Red Cross Hospital
Division name
1) Department of Rheumatology Rheumatism department and glue field disease internal medicine department 2) Glue field disease rheumatism internal medicine department
Zip code
Address
1) 3211 Kozukue-Cho,Kohoku-Ku, Yokohama City, Kanagawa Prefecture, Japan 2) 3-12-1,Shinyamashita,Nakaku, Yokohama City, Kanagawa Prefecture, Japan
TEL
045-474-8111
kitayas@yokohamah.rofuku.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Kita |
Organization
Japan Labour Health and Welfare Organization,
Division name
Department of Rheumatology
Zip code
Address
3211 Kozukue-Cho,Kohoku-Ku, Yokohama City, Kanagawa Prefecture, Japan
TEL
045-474-8111
Homepage URL
kitayas@yokohamah.rofuku.go.jp
Sponsor or person
Institute
Japan Labour Health and Welfare Organization,
Yokohama Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Labour Health and Welfare Organization,
Yokohama Rosai Hospital
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
横浜労災病院
横浜市立みなと赤十字病院
横浜医療センター
横浜中央病院
亀田病院
綱島鈴木整形外科
ひろた内科クリニック
都筑あずま内科リウマチ科
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 12 | 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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 11 | Day |
Last modified on
| 2015 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009886
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
