UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Success of tocilizumab in RA patients with remission induction and sustained efficacy after discontinuation
Title of the study (Brief title)	Surprise study
Region	Japan

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

Objectives
Narrative objectives1	To assess the efficacy and safety of tocilizumab with methotrexate in rheumatoid arthritis, and sustained efficacy after discontinuation of tocilizumab
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	remission rate at 24 weeks (DAS28-ESR)
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	tocilizumab plus methotrexate
Interventions/Control_2	tocilizumab
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients with rheumatoid arthritis diagnosed according to the criteria of the American College of Rheumatology (ACR) 2) Patients treated with more than 6mg/week dose of methotrexate for more than 8 weeks 3) Patients whose disease duration are less than 10 years 4) DAS28-ESR score less than 3.2 at the time of entry
Key exclusion criteria	1) Patients whose Steinbrocker functional classification are class 4 2) Patients treated with leflunomide, disease modifying anti-rhuematic disease drugs without methotrexate, or tacrolimus 3) Patients who have ever treated with any of biologic agents 4) Patients treated with 10mg/day of predonisolone 5) Patients whose WBC is less than 4000 or lymphocytes is less than 1000 6) Patients with infection of HBV or EBV
Target sample size	300

Research contact person
Name of lead principal investigator	Tsutomu Takeuchi
Organization	Department of Internal Medicine, Keio University School of Medicine
Division name	Division of Rheumatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
TEL	0333531211
Email	tsutake@z5.keio.jp

Public contact
Name of contact person	Yuko Kaneko
Organization	Department of Internal Medicine, Keio University School of Medicine
Division name	Division of Rheumatology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
TEL	0333531211
Homepage URL	http://www.keio-rheum.jp/
Email	ykaneko@z6.keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	nonprofit organization ACRO
Organization
Division
Category of Funding Organization	Other
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	2009 Year 11 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 10 Month 03 Day
Anticipated trial start date	2009 Year 11 Month 01 Day
Last follow-up date	2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 11 Month 10 Day
Last modified on	2018 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003337