UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000639 |
|---|---|
| Receipt number | 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 09:08:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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 | 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
Value
https://center6.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 |
