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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000007076
Receipt No. R000005707
Scientific Title Rituximab treatment for patients with Wegener's granulomatosis
Date of disclosure of the study information 2012/01/16
Last modified on 2015/01/22

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Basic information
Public title Rituximab treatment for patients with Wegener's granulomatosis
Acronym Rituximab treatment for Wegener's granulomatosis
Scientific Title Rituximab treatment for patients with Wegener's granulomatosis
Scientific Title:Acronym Rituximab treatment for Wegener's granulomatosis
Region
Japan

Condition
Condition Wegener's granulomatosis
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 with Wegener's granulomatosis
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

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 500 mg for 4 times
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 The case of Wegener's granulomatosis resistant to standard therapy with cyclophosphamide
Key exclusion criteria The case who is disqualified by the physician
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Morita
Organization Kawasaki Medical School
Division name Department of Rheumatology
Zip code
Address 577 Matushima, Kurashiki, Okayama, Japan
TEL 086-462-1111
Email rheumatology@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitaka Morita
Organization Kawasaki Medical School
Division name Department of Rheumatology
Zip code
Address 577 Matushima, Kurashiki, Okayama, Japan
TEL 086-462-1111
Homepage URL
Email morita@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
Organization
Division
Category of Funding Organization Self funding
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 川崎医科大学附属病院(岡山県)

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2011 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 01 Month 16 Day
Last modified on
2015 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005707

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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