UMIN-CTR Clinical Trial

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 Naoto Middle name Last name Tamura
Organization	Juntendo University
Division name	Department of Internal Medicine and Rheumatology
Zip code	1130033
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 Yoshiyuki Middle name Last name Abe
Organization	Juntendo University
Division name	Department of Internal Medicine and Rheumatology
Zip code	1130033
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	Juntendo University
Address	2-1-1, Hongo, Bunkyo-Ku, Tokyo
Tel	0338133111
Email	kenkyu5858@juntendo.ac.jp

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	44
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	Terminated
Date of protocol fixation	2019 Year 01 Month 07 Day
Date of IRB	2019 Year 01 Month 09 Day
Anticipated trial start date	2019 Year 02 Month 13 Day
Last follow-up date	2024 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Transition to jRCT.(jRCT1031180196)

Management information
Registered date	2019 Year 02 Month 13 Day
Last modified on	2020 Year 02 Month 19 Day

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