UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012227 |
|---|---|
| Receipt number | R000014294 |
| Scientific Title | A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus |
| Date of disclosure of the study information | 2013/11/06 |
| Last modified on | 2015/12/12 11:39:18 |
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Basic information
Public title
A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus
Acronym
A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus
Scientific Title
A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus
Scientific Title:Acronym
A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus
Region
| Japan |
Condition
Condition
Systemic lupus erythmatosus
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and the safety of bortezomib for patients with refractory SLE.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Change of anti-dsDNA antibody
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
bortezomib(1.3mg/m2)
2times/week total 8times.
Interventions/Control_2
saline
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) age of 20y/o to 65 y/o
2) ALE diagnosed with ACR criteria
3) Treated with Predonisolone (more than 10mg/day and 6 months)
4) Treated with Immunosuppressant(more than 3 months)
5) SELENA-SLEDAI (6-31)
6) positive anti-dsDNA antiboy
7) Written informed consent to participate.
Key exclusion criteria
1) Previous bortezomib administration
2) Incresed steroid within 14 days.
3) History of malignacy.
4) Patients with peripheral neuropathy.
5) Patients with CNS lupus.
6) Patients with sevear renal disease.
7) History of hypersensitivity to mannitol or bolic acid.
8) Patients with interstitial pneumonia or pulmonary fibrosis.
9) Patients with sevear heart disease.
10) Patients with positive HBs Ag or HIV Ab or HCV Ab.
11) patients with hyperkalemia.
12) Patients with psychiatric disease.
13) Patients with sevear liver dysfunaction
14) Patients with uncontrolled diabetes mellitus.
15) Patients with uncontrolled hypertension.
16) Current or previous within the last 30 days history of sevear infectious
disease.
17) The pregnant and lactating female , female who has possibility of the pregnancy.
18) Patients who were judged inappropriate to entry this study by physician
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideo harigae |
Organization
Tohoku university hospital
Division name
Hematology and Rheumatology
Zip code
Address
1-1, Seiryocho, Aobaku, Sendai, Miyagi
TEL
022-717-7165
harigae@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomonori Ishii |
Organization
Tohoku university hospital
Division name
Hematology and Rheumatology
Zip code
Address
1-1, Seiryocho, Aobaku, Sendai, Miyagi
TEL
022-717-7165
Homepage URL
tishii@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku university hospital
Institute
Department
Personal name
Funding Source
Organization
MHLW
Organization
Division
Category of Funding 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
| 2013 | Year | 11 | Month | 06 | 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
| 2013 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 06 | Day |
Last modified on
| 2015 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014294
