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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000639
Receipt No. R000000775
Scientific Title A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus Erythematosus
Date of disclosure of the study information 2007/03/16
Last modified on 2010/12/06

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Basic information
Public title A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus Erythematosus
Acronym Rituximab clinical Investigation in Systemic lupus Erythematosus (RISE study)
Scientific Title A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase II/III study of Rituximab in Patients with Systemic Lupus Erythematosus
Scientific Title:Acronym Rituximab clinical Investigation in Systemic lupus Erythematosus (RISE study)
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 Comparison of overall response rate between IDEC-C2B8 and placebo.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 IDEC-C2B8 plus oral prednisolone(tapering)
1000 mg of IDEC-C2B8 on days 1 and 15.Repeated at an interval of 6 months (Days 169 and 183).
Interventions/Control_2 Placebo plus oral prednisolone(tapering)
1000 mg of placebo day 1 and 15.Repeated at an interval of 6 months (Days 169 and 183).
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 Patients who meet all of the following criteria will be enrolled in this study:
1)Patients with SLE diagnosed according to the criteria of the American College of Rheumatology (ACR) (revised version, 1997) and with positive antinuclear antibody
2)Patients who develop moderate or severe flares (one or more BILAG category A, or two or more BILAG category B) in spite of 2 weeks or longer therapy with corticosteroids.
3) As for patients receiving immunosuppressant, the immunosuppressant should be limited to only one, and be limited to azathioprine, 6-mercaptopurine (6-MP), mycophenolate mofetil (MMF) or methotrexate (MTX); and the dosage should not be changed within 4 weeks prior to screening.
4)Sixteen to 75 years of age at the time of signing an informed consent form.
5)Patients who agreed to practice an appropriate contraception during the study period and until recovery of CD20 positive cell.
Key exclusion criteria 1.SLE exclusion
1)Unstable patients with thrombocytopenia
2)Proteinuria>1.0g/24hr
3)Retinitis, unfavorably controlled seizure disorder, confusional state, myelitis, stroke syndrome, cerebellar ataxia, or dementia that is associated with SLE
4)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 medical disease in any organ system not related to SLE
4)Require treatments with systemic corticosteroid within one year
5)Active infection
6)Some infection requiring hospitalization, or therapy with intravenous antibiotics within 8 weeks, or therapy with oral antibiotics within 2 weeks
7)Deep-seated infection within one year
8)Serious recurrent or chronic infection
9)History of any malignancy
10)Active alcohol or drug abuse or history of alcohol or drug abuse
11)Major surgery within 4 weeks
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
4)Severe allergic or anaphylactic reactions to acetaminophen and d-chlorpheniramine maleate, and patients have not tolerability or contraindication for steroid therapy with intravenous and oral
5)Treated with <0.75 mg/kg/day of prednisolone for 7 days or more within 4 weeks
6)Treated with new immunosuppressant(s) within 12 weeks; or whom dosage of a immunosuppressant have been changed within 4 weeks
7)Treated with cyclophosphamide, calcineurin inhibitors such as cyclosporine and tacrolimus within 12 weeks
8)Treated with whole blood or blood component transfusion, immune adsorption, hemodialysis within 4 weeks
4.Laboratory exclusion
1)AST, ALT>Nu x 2.5
2)serum creatinine>2.5mg/dL
3)neutrophil<1500/uL
4)Hb<7.0g/dL
5)Thrombocyte<10000/uL
6)Positive HIV, HCV, HBs, Hbc
Target sample size 150

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
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 03-3946-1113
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 03 Month 16 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 01 Month 19 Day
Date of IRB
Anticipated trial start date
2007 Year 03 Month 01 Day
Last follow-up date
2011 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 03 Month 16 Day
Last modified on
2010 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000775

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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