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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000762
Receipt No. R000000914
Scientific Title Phase II study of Rituximab in Patients with Systemic Lupus Erythematosus
Date of disclosure of the study information 2007/07/05
Last modified on 2011/07/08

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Basic information
Public title Phase II study of Rituximab in Patients with Systemic Lupus Erythematosus
Acronym Compassionate open study of Rituximab in Systemic lupus Erythematosus
Scientific Title Phase II study of Rituximab in Patients with Systemic Lupus Erythematosus
Scientific Title:Acronym Compassionate open study of Rituximab in 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 IDEC-C2B8 in patients with moderate to severe systemic lupus erythematosus showing inadequate response to conventional 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 IDEC-C2B8 on days 1 and 15.Repeated at an interval of 6 months (Days 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

Not applicable
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients who perticipated in the II/III study (Protocol No.IDEC-C2B8-A3) and were allocated to placebo group.
2.Under 80 years of age at the time of signing an informed consent form etc.
Key exclusion criteria 1)Proteinuria>1.0g/24hr
2)APS complication
3)Pregnant women or lactating mothers
4)Positive HIV, HCV, HBs, HBc etc.
Target sample size 70

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 License-in Product Development Section
TEL
Email

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
Email

Sponsor
Institute Zenyaku Kogyo Co., Ltd.
Institute
Department

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
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

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
2012 Year 03 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
2011 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000914

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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