UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012409 |
|---|---|
| Receipt number | 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 17:54:01 |
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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
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/
itoshi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
University of Miyazaki Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014524
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