systemic lupus erythematosus , SLE
Conditions
Interventions
The investigator will randomly assign participants to either the biologics combination group or the non-combination group.
Sponsors
Minowa Kentaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who have provided written consent to participate in the study Male and female patients aged 20 years or older but under 80 years at the time of consent acquisition Patients diagnosed with SLE according to any of the following criteria: ACR Classification Criteria, SLICC Classification Criteria, or EULAR/ACR Classification Criteria, before consent acquisition Patients who are in a clinically quiescent state at the time of consent acquisition and have either anti-DNA antibody positivity or low complement levels (C3, C4, or CH50 below normal range) that have persisted for over 6 months Patients whose glucocorticoid (GC) dosage has been maintained at 3 mg/day or more but 7.5 mg/day or less in PSL equivalent for at least 6 months at the time of consent acquisition Patients who have been taking hydroxychloroquine (HCQ) for at least 12 months prior to consent acquisition Patients who have not initiated any new immunosuppressive (IS) agents for at least 12 months prior to consent acquisition Patients whom the principal (or sub-investigator) deems capable of being adequately assessed for the efficacy and safety of this study, taking into consideration the inclusion and exclusion criteria
Exclusion criteria
Exclusion criteria: Patients with a history of belimumab or anifrolumab administration within 6 months prior to consent acquisition Patients with severe liver dysfunction Patients with concurrent malignant tumors or a history of malignancy within the past 5 years Patients with chronic infections Patients who are HIV-positive, HCV-positive, or HBV DNA PCR-positive Patients who are pregnant or breastfeeding Patients unable to use effective contraception during study participation Patients with a history of depression diagnosis Patients deemed unsuitable for enrollment by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who were able to discontinue GC without experiencing a relapse of SLE at the final evaluation (Week 96). *Relapse is defined based on the SELENA-SLEDAI Flare Index (SFI) as mild to moderate or greater flare. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Proportion of patients who discontinued GC without experiencing an SLE relapse [at 24, 48, and 72 weeks of treatment] 2 Proportion of patients who reduced GC to PSL < 2.5mg/day without experiencing an SLE relapse [at 24, 48, 72, and 96 weeks of treatment] 3 Proportion of patients who reduced GC to PSL < 5mg/day without experiencing an SLE relapse [at 24, 48, 72, and 96 weeks of treatment] 4 SLE relapse rate [based on SFI] [at 24, 48, 72, and 96 weeks of treatment] 5 Kaplan-Meier survival analysis of time to first relapse during the treatment period 6 Change in GC dosage from baseline [start of treatment] [at 24, 48, 72, and 96 weeks of treatment] 7 Proportion of patients with an increase in SDI from baseline [start of treatment] [at 24, 48, 72, and 96 weeks of treatment] 8 Change in SDI from baseline [start of treatment] [at 24, 48, 72, and 96 weeks of treatment] 9 Change in patient VAS from baseline [start of treatment] [at 24, 48, 72, and 96 weeks of treatment] 10 Change in physician VAS from baseline [start of treatment] [at 24, 48, 72, and 96 weeks of treatment] 11 Change in Fatigue Assessment score from baseline [start of treatment] [at 24, 48, 72, and 96 weeks of treatment] 12 Occurrence of noteworthy adverse events Severe hypersensitivity Infections Herpes zoster Progressive multifocal leukoencephalopathy [PML] Interstitial pneumonia Depression, suicidal ideation, or suicide attempts 13 Occurrence of other diseases or conditions | — |
Contacts
Public ContactKentaro Minowa
Juntendo University Hospital
Outcome results
None listed