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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012409
Receipt No. R000014524
Scientific Title An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis
Date of disclosure of the study information 2013/12/04
Last modified on 2019/12/02

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Basic information
Public title An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis
Acronym RITAZAREM
Scientific Title An international, open label, randomised controlled trial comparing rituximab with azathioprine as maintenance therapy in relapsing ANCA-associated vasculitis
Scientific Title:Acronym RITAZAREM
Region
Japan North America South America
Australia Europe

Condition
Condition Granulomatosis With Polyangiitis (Wegener's)
Microscopic Polyangiitis
Classification by specialty
Medicine in general Nephrology Clinical immunology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To demonstrate the superiority of rituximab against azathioprine in the prevention of disease flare in AAV patients with relapsing disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Time to disease relapse (either minor or major relapse) from randomisation
Key secondary outcomes 1. Proportion of patients who maintain remission at 24 and 48 months
2. Time to a major or second minor relapse
3. Cumulative accrual of damage as measured by the combined damage assessment score (CDA)
4. Health-related quality of life as measured using SF-36
5. Cumulative glucocorticoid exposure
6. Severe adverse event rate
7. Infection rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Experimental: Rituximab Maintenance.
Rituximab maintenance: 1g at 4, 8, 12, 16 & 20 months with standardised steroid taper.
Interventions/Control_2 Active Comparator: Azathioprine Maintenance.
Azathioprine Maintenance: 2mg/kg/day with standardised steroid taper, from month 4 (randomisation). Azathioprine withdrawn at month 27.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Participants must meet all of the following criteria to be eligible for enrolment:

1). Written informed consent
2). A diagnosis of AAV (granulomatosis with polyangiitis (Wegener's) or microscopic polyangiitis), according to the definitions of the Chapel Hill Consensus Conference
3). Current or historical ANCA positivity either by ELISA or immunofluorescence.
4). Disease relapse defined by one major or three minor disease activity items on the Birmingham Vasculitis Activity Score for Wegener's (BVAS/WG), in patients that have previously achieved remission following induction therapy

All patients will receive induction therapy with rituximab. Only those entering remission by 4 months will be randomised 1:1 to the rituximab or control groups.
Key exclusion criteria 1). Age < 18 years.

2). Previous therapy with:
a). Any biological B cell depleting agent within the past 6 months
b). Alemtuzumab or anti-thymocyte globulin within the last 12 months;
c). IVIg, infliximab, etanercept, adalimumab, abatacept or plasma exchange in past 3 months;
d). Any investigational agent within 28 days of screening, or 5 half lives of the investigational drug (whichever is longer).

3). Exclusions related to general health:
a). Significant or uncontrolled medical disease not related to AAV, which in the investigators opinion would preclude patient participation;
b). Presence of another multisystem autoimmune disease, including Churg Strauss syndrome, systemic lupus erythematosus, anti-GBM disease, or cryoglobulinaemic vasculitis;
c). Any concomitant condition anticipated to likely require greater than 4 weeks per year of oral or systemic glucocorticoid use and which would preclude compliance with the glucocorticoid protocol (e.g. poorly-controlled asthma, COPD, psoriasis, or inflammatory bowel disease);
d). History of severe allergic or anaphylactic reactions to humanised or murine chimeric monoclonal antibodies;
e). Known infection with HIV, a past or current history of hepatitis B virus or hepatitis C virus infection;
f). Ongoing or recent (last 12 months) evidence of active tuberculosis or known active infection or evidence of untreated latent tuberculosis. Screening for tuberculosis is as per local practice;
g). History of malignancy within the past five years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ which has been treated or excised in a curative procedure;
h). Pregnancy or inadequate contraception in pre-menopausal women;
i). Breast feeding or lactating.

4. Exclusion criteria related to laboratory parameters:
a). Bone marrow suppression;
b). Elevation of Aspartate aminotransferase or alanine aminotransferase or amylase
Target sample size 190

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shouichi Fujimoto
Organization University of Miyazaki Hospital
Division name Department of Hemovascular Medicine and Artificial Organs, Faculty of Medicine, University of Miyazaki
Zip code
Address 5200 Kihara, Kiyotake-cho, Miyazaki 889-1692 Japan
TEL 0985-85-1510
Email fujimos@fc.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiko Ito-Ihara
Organization Kyoto University Hospital
Division name Institute for Advancement of Clinical and Translational Science
Zip code
Address 54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto 606-8507 Japan
TEL 075-751-4739
Homepage URL http://rarediseasesnetwork.epi.usf.edu/vcrc/ritazarem/
Email itoshi@kuhp.kyoto-u.ac.jp

Sponsor
Institute University of Miyazaki Hospital
Institute
Department

Funding Source
Organization Grants from Research Committee on Intractable Vasculitides, the Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor The European Vasculitis Society
Vasculitis Clinical Research Consortium
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT01697267
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2 2012-001102-14
Org. issuing International ID_2 EUDRACT
IND to MHLW

Institutions
Institutions 宮崎大学医学部附属病院 University of Miyazaki, Miyazaki、田附興風会医学研究所北野病院 Kitano Hospital, Osaka、千葉大学医学部附属病院 Chiba University, Chiba、岡山大学病院 Okayama University, Okayama、帝京大学医学部附属病院 Teikyo Univesity, Tokyo、杏林大学医学部付属病院 Kyorin University, Tokyo、東京都健康長寿医療センター Tokyo Metropolitan Geriatric Hospital, Tokyo.

Other administrative information
Date of disclosure of the study information
2013 Year 12 Month 04 Day

Related information
URL releasing protocol http://rarediseasesnetwork.epi.usf.edu/vcrc/ritazarem/
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
2012 Year 07 Month 19 Day
Date of IRB
2014 Year 01 Month 31 Day
Anticipated trial start date
2014 Year 06 Month 26 Day
Last follow-up date
2019 Year 10 Month 30 Day
Date of closure to data entry
2019 Year 12 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 30 Day
Date analysis concluded
2020 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 11 Month 26 Day
Last modified on
2019 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014524

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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