UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002892 |
|---|---|
| Receipt number | 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 10:10:24 |
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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
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
office.mhlw.vasculitis-res@marianna-u.ac.jp
Sponsor or person
Institute
Research Committee of multicentre clinical trials for intractable ANCA-associated vasculitis of the Ministry of Health, Labor and Welfare of Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003525
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
