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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007380
Receipt No. R000008695
Scientific Title Comparison of the effects of single high-dose methotrexate and methotrexate-tocilizumab therapy on rheumatoid arthritis
Date of disclosure of the study information 2012/05/01
Last modified on 2018/09/01

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Basic information
Public title Comparison of the effects of single high-dose methotrexate and methotrexate-tocilizumab therapy on rheumatoid arthritis
Acronym Comparison of tocilizumab and high-dose methotrexate on rheumatoid arthritis
Scientific Title Comparison of the effects of single high-dose methotrexate and methotrexate-tocilizumab therapy on rheumatoid arthritis
Scientific Title:Acronym Comparison of tocilizumab and high-dose methotrexate on rheumatoid arthritis
Region
Japan

Condition
Condition rheumatoid arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effects of single high-dose methotrexate (10 to 16 mg/W) and methotrexate(10 mg/W)-tocilizumab therapy on rheumatoid arthritis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To determine which is acceptable; to increase the dose of MTX upto 16 mg/W or to add tocilizumab on 10 mg of MTX through assessment of the clinical outcome by DAS28 and frequency of adverse reaction in the clinical course.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 tocilizumab + methotrexate (10mg/week)
Interventions/Control_2 high-dose methotrexate (stepwisely increased to 16mg/week)
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
80 years-old >
Gender Male and Female
Key inclusion criteria Patients who fulfilled 1987 ACR and 2010 ACR/EULAR critereia of RA
Patients not treated with Biologics
Patients treated with MTX of 10 mg/week more than 4weeks
Active RA patients of DAS28 >/= 3.2
Key exclusion criteria TCZ intolerable patients
Pregnant or possibly pregnant patients
Serum ALT >/= 3x normal value
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masanori Funauchi
Organization Kinki University Facalty of Medicine
Division name Division of Hematology and Rheumatology
Zip code
Address 377-2 Ohnohigashi, Osakasayama, Osaka Japan
TEL 0723660221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Nozaki
Organization Kinki University Faclty of Medicine
Division name Division of Hematology and Rheumatology
Zip code
Address 377-2 Ohnohigashi, Osakasayama, Osaka Japan
TEL
Homepage URL
Email

Sponsor
Institute Kinki University Faculty of Medicine, Division of Hematology and Rheumatology
Institute
Department

Funding Source
Organization Kinki University Faculty of Medicine, Division of Hematology and Rheumatology
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

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 01 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 Terminated
Date of protocol fixation
2012 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2012 Year 04 Month 01 Day
Date of closure to data entry
2012 Year 04 Month 01 Day
Date trial data considered complete
2012 Year 04 Month 01 Day
Date analysis concluded
2012 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 02 Month 26 Day
Last modified on
2018 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008695

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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