Unique ID issued by UMIN | UMIN000013508 |
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Receipt number | R000015784 |
Scientific Title | A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus:cross over additional trial |
Date of disclosure of the study information | 2014/03/26 |
Last modified on | 2015/12/12 11:40:14 |
A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus:cross over additional trial
A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus:cross over additional trial
A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus:cross over additional trial
A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus:cross over additional trial
Japan |
Systemic lupus erythmatosus
Clinical immunology |
Others
NO
To evaluate the efficacy and the safety of bortezomib for patients with refractory SLE.
Safety,Efficacy
Exploratory
Phase II
Change of anti-dsDNA antibody
SLEDAI
BILAG
SRI
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
saline
bortezomib(1.3mg/m2)
2times/week total 8times.
20 | years-old | <= |
65 | years-old | >= |
Male and Female
1) age of 20y/o to 65 y/o
2)Patients to attend a phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus
7) Written informed consent to participate.
1) History of malignacy.
2) Patients with peripheral neuropathy.
3) Patients with CNS lupus.
4) Patients with sevear renal disease.
5) History of hypersensitivity to mannitol or bolic acid.
6) Patients with interstitial pneumonia or pulmonary fibrosis.
7) Patients with sevear heart disease.
8) Patients with positive HBs Ag or HIV Ab or HCV Ab.
9) patients with hyperkalemia.
10) Patients with psychiatric disease.
11) Patients with sevear liver dysfunaction
12) Patients with uncontrolled diabetes mellitus.
13) Patients with uncontrolled hypertension.
14) Current or previous within the last 30 days history of sevear infectious
disease.
15) The pregnant and lactating female , female who has possibility of the pregnancy.
16) Patients who were judged inappropriate to entry this study by physician
14
1st name | |
Middle name | |
Last name | Hideo harigae |
Tohoku university hospital
Department of 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
Department of Hematology and Rheumatology
1-1, Seiryocho, Aobaku, Sendai, Miyagi
022-717-7165
tishii@med.tohoku.ac.jp
Tohoku university hospital
MHLW
Japan
NO
2014 | Year | 03 | Month | 26 | Day |
Unpublished
Completed
2014 | Year | 01 | Month | 16 | Day |
2014 | Year | 03 | Month | 28 | Day |
2014 | Year | 03 | Month | 25 | Day |
2015 | Year | 12 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015784
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