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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002744
Receipt No. R000003337
Scientific Title Success of tocilizumab in RA patients with remission induction and sustained efficacy after discontinuation
Date of disclosure of the study information 2009/11/10
Last modified on 2018/03/13

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Basic information
Public title Success of tocilizumab in RA patients with remission induction and sustained efficacy after discontinuation
Acronym Surprise study
Scientific Title Success of tocilizumab in RA patients with remission induction and sustained efficacy after discontinuation
Scientific Title:Acronym 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
1st name
Middle name
Last name Tsutomu Takeuchi
Organization Department of Internal Medicine, Keio University School of Medicine
Division name Division of Rheumatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JAPAN
TEL 0333531211
Email tsutake@z5.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuko Kaneko
Organization Department of Internal Medicine, Keio University School of Medicine
Division name Division of Rheumatology
Zip code
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)

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
2009 Year 11 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

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
2009 Year 10 Month 03 Day
Date of IRB
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

Other
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

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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