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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035865
Receipt No. R000040854
Scientific Title Optimal regimens of glucocorticoids tapering for remission induction therapy in patients with severe systemic lupus erythematosus : multi-center randomized open label trial
Date of disclosure of the study information 2019/02/13
Last modified on 2019/02/13

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Basic information
Public title Optimal regimens of glucocorticoids tapering for remission induction therapy in patients with severe systemic lupus erythematosus : multi-center randomized open label trial
Acronym Optimal regimens of glucocorticoids tapering in patients with systemic lupus erythematosus
Scientific Title Optimal regimens of glucocorticoids tapering for remission induction therapy in patients with severe systemic lupus erythematosus : multi-center randomized open label trial
Scientific Title:Acronym Optimal regimens of glucocorticoids tapering in patients with systemic lupus erythematosus
Region
Japan

Condition
Condition systemic lupus erythematosus
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In patients with severe SLE, noninferiority is examined by comparing the relapse-free survival rate of the corticosteroid rapidly decreasing group and the conventional therapy group.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relapse free survival rate at week 52.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dose of glucocorticoids.

Rapid tapering group
After continuing the initial dose for 2 to 4 weeks, weigh down every 1 week according to the following dose
60 mg, 50 mg, 45 mg, 40 mg, 35 mg, 30 mg,
(Tapering every week, continuation of hospitalization, subsequent doses are exclusive to outpatient physician)
Interventions/Control_2 Conventional therapy group
Initial dose is continued for 2 to 4 weeks and then reduced every 2 weeks according to the following dose
60 mg, 50 mg, 45 mg, 40 mg, (Tapering every 2 weeks, be sure to continue hospitalization)
37.5 mg, 35 mg, 32.5 mg, 30 mg, (Tapering every 4 weeks, subsequent doses are exclusive to outpatient physician)
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients over 20 years old
2) Patients who got consent in writing
3) Patients who met SLE classification criteria or SLICC classification criteria of the American College of Rheumatology 1997 and were diagnosed with SLE in 1997
4) In principle, a combination of immunosuppressive drugs receiving medicine of corticosteroid at a dose of 0.5 mg / kg / day or more and 40 mg / day in terms of prednisolone is used but patients with or without interruption due to side effects etc.
Key exclusion criteria 1) Persons who did not obtain consent
2) Patients with poorly controlled complications
3) Pregnant or lactating women
4) Male and female with pregnancy plan within 52 weeks
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoto Tamura
Organization Juntendo University
Division name Department of Internal Medicine and Rheumatology
Zip code
Address 2-1-1, Hongo, Bunkyo-Ku, Tokyo, Japan
TEL 03-3813-3111
Email tnaoto@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Abe
Organization Juntendo University
Division name Department of Internal Medicine and Rheumatology
Zip code
Address 2-1-1, Hongo, Bunkyo-Ku, Tokyo, Japan
TEL 03-3813-3111
Homepage URL
Email yo-abe@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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
2019 Year 02 Month 13 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 Open public recruiting
Date of protocol fixation
2019 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 13 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
2019 Year 02 Month 13 Day
Last modified on
2019 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040854

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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