UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000906 |
|---|---|
| Receipt number | R000001079 |
| Scientific Title | Rituximab treatment of cyclophosphamide-resistant patients with ANCA-associated vasculitis |
| Date of disclosure of the study information | 2007/12/01 |
| Last modified on | 2013/06/14 10:12:51 |
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Basic information
Public title
Rituximab treatment of cyclophosphamide-resistant patients with ANCA-associated vasculitis
Acronym
RiCRAV
Scientific Title
Rituximab treatment of cyclophosphamide-resistant patients with ANCA-associated vasculitis
Scientific Title:Acronym
RiCRAV
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 rituximab for the treatment of cyclophosphamide-resistant patients with ANCA-associated vasculitis, and to analyze predictive factors for the responsiveness to rituximab.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
complete remission at 12 months
Key secondary outcomes
adverse events, BVAS/WG, VDI
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
Weekly infusion of Rituximab 375mg per square meter for 4 times plus oral daily prednisolone 0.5-1mg/kg for 2 weeks and tapered.
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
Fulfil 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;
A, failed to induce remission after 6 months of cyclophosphamide therapy.
B, relapsed within 1 year of remission induction therapy with cyclophosphamide.
C, difficult to repeat cyclophosphamide because of adverse reaction.
Key exclusion criteria
1. severe infection (including tuberculosis, HCV, HBV and HIV).
2. history of hypersensitivity to mouse-derived protein
3. congestive heart failure with NYHA III or IV
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichi Ozaki |
Organization
St. Marianna University School of Medicine
Division name
Division of Rheumatology and Allergy
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki
TEL
044-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
St. Marianna University School of Medicine
Division name
Division of Rheumatology and Allergy
Zip code
Address
TEL
Homepage URL
office.mhlw.vasculitis-res@marianna-u.ac.jp
Sponsor or person
Institute
Research Comittee of Intractable Vasculitis Syndrome 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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 12 | Month | 01 | 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
| 2006 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 24 | 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=R000001079
