UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018376 |
|---|---|
| Receipt number | R000021230 |
| Scientific Title | Efficacy and safety of rituximab for patients with severe rheumatic disease |
| Date of disclosure of the study information | 2015/07/22 |
| Last modified on | 2019/04/17 21:38:07 |
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Basic information
Public title
Efficacy and safety of rituximab for patients with severe rheumatic disease
Acronym
Efficacy and safety of rituximab for patients with severe rheumatic disease
Scientific Title
Efficacy and safety of rituximab for patients with severe rheumatic disease
Scientific Title:Acronym
Efficacy and safety of rituximab for patients with severe rheumatic disease
Region
| Japan |
Condition
Condition
Childhood-onset severe rheumatic disease
(systemic lupus erhythematosus, dermatomyositis, poly myositis, systemic sclerosis , mixed connective tissue disease, Sjogren's syndrome, anti-phospholipid syndrome)
Classification by specialty
| Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of rituximab in patients with childhood-onset rheumatic disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
inhibition of disease activity
Key secondary outcomes
improvement of physician's VAS, patient's VAS, biomarkers of disease activity and dose of corticosteroids
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
1) Induction Therapy
rituximab 375mg/m2 (max500mg)
1-4 times/1-2 weeks
2) Maintenance Therapy
rituximab 375mg/m2 (max500mg)
1 times/6-12 months
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
| 2 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Diagnose at Childhood(1 to 16years old), registance against standerd treatment or steroid-dependent
2. No experience of rituximab treatment
3. Patients gave written informed consent
Key exclusion criteria
1. Pulmonary tuberculosis, active bacterial infection or deep mycotic infection
2. Infection of HIV, HCV or HBV
3. Administraion of live vaccine within 4 weeks
4. Interstatial lung disease
5. Cardiac dysfunction
6. Pregnant subjects or subjects who do not agree with contraception during the study period
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Nishimura |
Organization
Yokohama City University Hospital
Division name
Pediatrics
Zip code
Address
Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa 236-0004, Japan
TEL
045-787-2800
ken_1_0306@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Nishimura |
Organization
Yokohama City University Hospital
Division name
Pediatrics
Zip code
Address
Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa 236-0004, Japan
TEL
045-787-2800
Homepage URL
ken_1_0306@hotmail.com
Sponsor or person
Institute
Yokohama City University Hospital Department of Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Propulsion Center of the Advanced Medical Technology at Yokohama City University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2015 | Year | 07 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 22 | Day |
Last modified on
| 2019 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021230
