UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000763 |
|---|---|
| Receipt number | R000000915 |
| Scientific Title | Phase II study of rituximab in patients with severe systemic lupus erythematosus |
| Date of disclosure of the study information | 2007/07/05 |
| Last modified on | 2010/12/06 09:09:34 |
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Basic information
Public title
Phase II study of rituximab in patients with severe systemic lupus erythematosus
Acronym
Rituximab clinical investigation in severe systemic lupus erythematosus
Scientific Title
Phase II study of rituximab in patients with severe systemic lupus erythematosus
Scientific Title:Acronym
Rituximab clinical investigation in severe systemic lupus erythematosus
Region
| Japan |
Condition
Condition
Systemic lupus erythematosus
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of rituximab in patients with severe systemic lupus erythematosus showing inadequate response to high-dose steroidal therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy evaluation
Key secondary outcomes
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
1000 mg of rituximab on days 1, 15, 169 and 183
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
| 16 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients with SLE diagnosed according to the American College of Rheumatology (ACR) criteria (revised version, 1997) and with positive antinuclear antibody
2)Patients who developed flares in spite of 2 weeks or longer therapy with high-dose corticosteroids
3)Age 16-75 years at the time of signing an informed consent form
5)Patients who agreed to practice an appropriate contraception during the study period, etc
Key exclusion criteria
1.SLE exclusion
1)APS complication
2.General health exclusion
1)Pregnant women or lactating mothers
2)History of severe allergic or anaphylactic reactions to humanized antibodies, murine antibodies or murine-derived products
3)Uncontrolled disease in any organ system not related to SLE
4)Require treatments with systemic corticosteroid within one year, etc
3.Medication exclusion
1)Treated with any B-cell targeted therapy
2)Received other investigational drug within 6 months, or participating another clinical investigation
3)Received a vaccine within 4 weeks, etc
4.Laboratory exclusion
1)AST, ALT>Nu x 2.5
2)serum creatinine>8.0mg/dL
3)neutrophil<1500/uL
4)Hb<7.0g/dL
5)thrombocyte<10,000/uL
6)Positive HIV, HCV, HBs, HBc
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiya Tanaka |
Organization
School of Medicine, University of Occupational and Environmental Health, Japan
Division name
First Department of Internal Medicine
Zip code
Address
1-1, Iseigaoka, Yahata-nishi-ku, Kitakyushu, Fukuoka, 807-8555, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Zenyaku Kogyo Co., Ltd.
Division name
License-in Product Development Section
Zip code
Address
TEL
Homepage URL
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
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
| 2007 | Year | 07 | Month | 05 | 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
| 2007 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 07 | Month | 05 | Day |
Last modified on
| 2010 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000915
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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