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

Email



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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name