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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012227
Receipt No. 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

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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
Email 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
Email tishii@med.tohoku.ac.jp

Sponsor
Institute Tohoku university hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014294

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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