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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002892
Receipt No. R000003525
Scientific Title Tocilizumab treatment of cyclophosphamide-resistant patients with ANCA-associated vasculitis
Date of disclosure of the study information 2009/12/14
Last modified on 2013/06/14

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Basic information
Public title Tocilizumab treatment of cyclophosphamide-resistant patients with ANCA-associated vasculitis
Acronym ToCRAV
Scientific Title Tocilizumab treatment of cyclophosphamide-resistant patients with ANCA-associated vasculitis
Scientific Title:Acronym ToCRAV
Region
Japan

Condition
Condition ANCA-associated vasculitis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the efficacy and safety of tocilizumab for the treatment of cyclophosphamide-resistant patients with ANCA-associated vasculitis and analyze predictive factors for the responsiveness to tocilizumab.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes remission induction
Key secondary outcomes adverse events, BVAS VDI, SF-36

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Infusion of Tocilizumab 8mg/kg every 2 weeks for one year.
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Fulfill the classification criteria of either Wegener's granulomatosis or microscopic polyangiitis based on the Ministry of Health, Labor and Welfare of Japan, and satisfy one of the following criteria;
1.failed to induce remission after 6 mounths of cyclophosphamide therapy.
2.difficult to taper steroid dose after remission induction with steroid and cyclophosphamide.
3.relapsed within 1 year of remission induction therapy with cyclophosphamide.
4.difficult to repeat cyclophosphamide because of adverse reaction.
Key exclusion criteria 1. severe infection (including tuberclosis and HIV).
2. Hepatitis B e antigen positive or Hepatitis C antibody positive.
3. Previous cyclophosphamide, (greater than 4 weeks of IV pulse cyclophosphamide regimen).
4. Previous cyclophosphamide, (greater than 2 weeks of an oral cyclophosphamide regimen).
5. WBC <3,500/microlitter.
6. platelet <100,000/microlitter.
7. lymphocytes<1,000/microlitter
8. Pregnancy or breast feeding
9. inadequate contraception
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoichi Ozaki
Organization St. Mariannna University school of Medicine
Division name Division of Rheumatology and Allergy
Zip code
Address 2-16-1,Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL 044-977-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hidehiro Yamada
Organization St. Mariannna University school of Medicine
Division name Division of Rheumatology and Allergy
Zip code
Address 2-16-1,Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL 044-977-8111
Homepage URL
Email office.mhlw.vasculitis-res@marianna-u.ac.jp

Sponsor
Institute Research Committee of multicentre clinical trials for intractable ANCA-associated vasculitis of the Ministry of Health, Labor and Welfare of Japan
Institute
Department

Funding Source
Organization the Ministry of Health, Labor and Welfare of Japan
Organization
Division
Category of Funding Organization
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 聖マリアンナ医科大学病院(東京都)
北海道大学附属病院(北海道)
神戸大学附属病院(兵庫県)
順天堂大学越谷病院(埼玉県)
筑波大学附属病院(茨城県)
岡山大学附属病院(岡山県)
東京医科大学八王子医療センター(東京都)
自治医科大学附属病院(栃木県)

Other administrative information
Date of disclosure of the study information
2009 Year 12 Month 14 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 Completed
Date of protocol fixation
2009 Year 08 Month 12 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 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 12 Month 14 Day
Last modified on
2013 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003525

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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