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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008404
Receipt No. 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

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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
Email 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
Email kitayas@yokohamah.rofuku.go.jp

Sponsor
Institute Japan Labour Health and Welfare Organization,
Yokohama Rosai Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009886

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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