Unique ID issued by UMIN | UMIN000012227 |
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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 |
A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus
A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus
A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus
A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus
Japan |
Systemic lupus erythmatosus
Clinical immunology |
Others
NO
To evaluate the efficacy and the safety of bortezomib for patients with refractory SLE.
Efficacy
Exploratory
Phase II
Change of anti-dsDNA antibody
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Central registration
2
Treatment
Medicine |
bortezomib(1.3mg/m2)
2times/week total 8times.
saline
20 | years-old | <= |
65 | years-old | >= |
Male and Female
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.
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
14
1st name | |
Middle name | |
Last name | Hideo harigae |
Tohoku university hospital
Hematology and Rheumatology
1-1, Seiryocho, Aobaku, Sendai, Miyagi
022-717-7165
harigae@med.tohoku.ac.jp
1st name | |
Middle name | |
Last name | Tomonori Ishii |
Tohoku university hospital
Hematology and Rheumatology
1-1, Seiryocho, Aobaku, Sendai, Miyagi
022-717-7165
tishii@med.tohoku.ac.jp
Tohoku university hospital
MHLW
NO
2013 | Year | 11 | Month | 06 | Day |
Unpublished
Completed
2013 | Year | 10 | Month | 19 | Day |
2013 | Year | 11 | Month | 06 | Day |
2013 | Year | 11 | Month | 06 | Day |
2015 | Year | 12 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014294
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