UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011549 |
|---|---|
| Receipt number | R000013488 |
| Scientific Title | Rituxan injection specific drug use-results survey |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2016/02/22 11:48:28 |
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Basic information
Public title
Rituxan injection specific drug use-results survey
Acronym
Rituxan injection specific drug use-results survey
Scientific Title
Rituxan injection specific drug use-results survey
Scientific Title:Acronym
Rituxan injection specific drug use-results survey
Region
| Japan |
Condition
Condition
Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA)
Classification by specialty
| Medicine in general | Nephrology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm occurrences of infusion-related reactions and infections as well as efficacy in post-marketing use of rituximab for Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Safety (infusion-related reactions and infections)
2. Efficacy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients who have received rituximab for WG and MPA.
Key exclusion criteria
None
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichiro Inatomi |
Organization
Zenyaku Kogyo Co., Ltd.
Division name
Pharmacovigilance Department
Zip code
Address
6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo 112-8650, Japan
TEL
03-3946-1136
Kenichiro_Inatomi@mail.zenyaku.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Ando |
Organization
Zenyaku Kogyo Co., Ltd.
Division name
Pharmacovigilance Department
Zip code
Address
6-15, Otsuka 5-chome, Bunkyo-ku, Tokyo 112-8650, Japan
TEL
03-3946-1136
Homepage URL
Takashi_Ando@mail.zenyaku.co.jp
Sponsor or person
Institute
Zenyaku Kogyo Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Zenyaku Kogyo Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chugai Pharmaceutical Co., Ltd.
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
| 2013 | Year | 09 | 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
| 2013 | Year | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
infusion-related reactions, infections, BVAS
Management information
Registered date
| 2013 | Year | 08 | Month | 22 | Day |
Last modified on
| 2016 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013488
