UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035865 |
|---|---|
| Receipt number | 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 | 2020/02/19 08:34:34 |
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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 | 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
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
yo-abe@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040854
