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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000012227
Date of registration:	06/11/2013
Prospective Registration:	Yes
Primary sponsor:	Tohoku university hospital
Public title:	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 - A phase II randomized trial of evaluation for boltezomib in refractory Systemic lupus erythematosus
Date of first enrolment:	2013/11/06
Target sample size:	14
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014294
Study type:	Interventional
Study design:	Parallel Randomized
Phase:	Phase II

Countries of recruitment
Japan

Contacts

Name:	Hideo harigae
Address:	1-1, Seiryocho, Aobaku, Sendai, Miyagi Japan
Telephone:	022-717-7165
Email:	harigae@med.tohoku.ac.jp
Affiliation:	Tohoku university hospital Hematology and Rheumatology

Name:	Tomonori Ishii
Address:	1-1, Seiryocho, Aobaku, Sendai, Miyagi Japan
Telephone:	022-717-7165
Email:	tishii@med.tohoku.ac.jp
Affiliation:	Tohoku university hospital Hematology and Rheumatology

Key inclusion & exclusion criteria

Inclusion criteria:
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

Age minimum: 20years-old
Age maximum: 65years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Systemic lupus erythmatosus

Intervention(s)

bortezomib(1.3mg/m2) 2times/week total 8times.
saline

Primary Outcome(s)

Change of anti-dsDNA antibody

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

MHLW

Secondary Sponsor(s)

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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