UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007380 |
|---|---|
| Receipt number | 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 09:30:54 |
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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
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
Sponsor or person
Institute
Kinki University Faculty of Medicine, Division of Hematology and Rheumatology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008695
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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