UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042298 |
|---|---|
| Receipt number | R000048284 |
| Scientific Title | Elucidation of refractoriness in treating systemic lupus erythematosus |
| Date of disclosure of the study information | 2020/10/31 |
| Last modified on | 2025/02/25 10:53:20 |
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Basic information
Public title
A clinical research to find out the cause of difficulties in treating systemic lupus erythematosus
Acronym
Research for difficulties in SLE treatment
Scientific Title
Elucidation of refractoriness in treating systemic lupus erythematosus
Scientific Title:Acronym
Research for refractory SLE
Region
| Japan |
Condition
Condition
Systemic Lupus Erythematosus
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To find out biomarkers for refractoriness in treating SLE
Basic objectives2
Others
Basic objectives -Others
Biomarker exploration
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We did not set primary or secondary outcomes since this study is an exploratory research. We mainly search for cytokines or genes that are related to the refractoriness.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient Selection Criteria for Standard Treatment Refractoriness:
Patients receiving induction steroid treatment (prednisolone (PSL) 0.5-1 mg/kg/day) (criterion 1-1).
Patients who relapsed while in a stable-phase taking PSL 10mg/day or more who had been received relatively high-dose steroid treatment as a remission induction (PSL 0.5-1 mg/kg/day) (Criterion 1-2).
2. Criteria for patients with specific drug treatment resistance:
Patients whose doctor has decided to administer belimumab as treatment for SLE. Patients with mild to moderate SLE who have difficulty decreasing steroid dose even with steroid therapy combined with at least one type of immunosuppressive therapy.
3. Criteria for selecting difficult cases of steroid dose reduction due to fatigue:
Patients with normal serum complement, anti-DNA antibodies, CRP and taking less than 10 mg/day of PSL, yet described as "significant" or "severe" fatigue using the quality of life assessment tool (SSC), and patients with a feeling of "none" fatigue.
4. Healthy person
Use existing samples of healthy (anonymized (no correspondence table)) RNA collected in "G1006-5: Research on autoimmune disease-related genetic factors". Randomly select the target population so that there is no significant divergence in age and gender, but if the divergence is large, obtain new consent and collect blood samples.
Key exclusion criteria
Exclusion criteria common among studies corresponding to selection criteria 1-4 are patient's refusal to the consent and patients under 15 years of age. In addition, the following exclusion criteria is established.
1. Standard treatment refractory patient exclusion criteria: When the attending physician deems it inappropriate due to complications (eg, malignant tumor, renal disorder with eGFR <15, severe lung disorder, central nervous system disorder).
2. Exclusion criteria for patient's refractory to specific drug treatment: Excludes patients with central nervous system disorders and highly active nephritis. When the attending physician considers it inappropriate due to other complications (for example, malignant tumor, serious lung disorder).
3. Exclusion criteria for cases of difficulty in reducing steroid dose due to fatigue: When the attending physician deems it inappropriate due to taking medication for the patient, because of complications (eg, malignant tumor, renal disorder with eGFR <15, severe lung disorder, central nervous system disorder, hypothyroidism) and neuropsychiatric symptoms that can cause fatigue
4. Exclusion criteria for healthy subjects: When the attending physician deems it inappropriate due to complications (for example, complications of malignant tumors, autoimmune diseases, eGFR <15, serious lung disorders, central nervous system disorders).
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Yoshifuji |
Organization
Kyoto University Graduate School of Medicine
Division name
Clinical Immunology & Rheumatology
Zip code
6068507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
0757513111
yossii@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Yoshifuji |
Organization
Kyoto University Graduate School of Medicine
Division name
Clinical Immunology & Rheumatology
Zip code
6068507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
TEL
075-751-3111
Homepage URL
yossii@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
GSK
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
United States of America
Other related organizations
Co-sponsor
Kobe City Medical Center General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Support Ctr. Kyoto University Hospital
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto
Tel
075-751-4748
ctsodan@kuhp.kyoto-u.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
| 2020 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/39975549/
Number of participants that the trial has enrolled
44
Results
Comparison of differences in peripheral blood gene expression between responder and non-responder patients (defined by SLE disease activity index at 6 months) on belimumab treatment confirmed a significant increase in a specific fraction of peripheral blood B cells in the non-responder group. These results suggest that it is possible to develop a method for predicting response to belimumab treatment in advance.
Results date posted
| 2024 | Year | 05 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 02 | Month | 05 | Day |
Baseline Characteristics
90% were female. The median duration of disease was 13.5 years (interquartile range 6.0-23.5).
Participant flow
Consent was obtained. Peripheral blood samples were collected before treatment, 3 months after treatment, and 6 months after treatment.
Adverse events
None
Outcome measures
SLEDAI, 6 months after treatment
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 10 | Month | 30 | Day |
Last modified on
| 2025 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048284
