UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of the effects of single high-dose methotrexate and methotrexate-tocilizumab therapy on rheumatoid arthritis
Title of the study (Brief title)	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	Masanori Funauchi
Organization	Kinki University Facalty of Medicine
Division name	Division of Hematology and Rheumatology
Address	377-2 Ohnohigashi, Osakasayama, Osaka Japan
TEL	0723660221
Email

Public contact
Name of contact person	Yuji Nozaki
Organization	Kinki University Faclty of Medicine
Division name	Division of Hematology and Rheumatology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 03 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000008695