Exploratory study for the usefulness of early introduction of anifrolumab in the first remission induction therapy for systemic lupus erythematosus
- Conditions
- systemic lupus erythematosus
- Registration Number
- JPRN-jRCTs031230358
- Lead Sponsor
- Tsuboi Hiroto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
1) Diagnosed with SLE based on either the 2019 EULAR/ACR classification criteria or the 1997 ACR classification criteria
2) No history of systemic administration of immunosuppressive or immunomodulatory drugs for SLE and within six months of diagnosis
3) SLEDAI-2K score of 4 or higher, indicating active disease
4) Age 18 years or older and younger than 80 years at the time of obtaining consent
5) Patients who have provided written consent for study participation after receiving a full explanation and understanding
1) Steroid therapy exceeding a prednisolone equivalent dose of 0.6mg/kg/day as initial treatment
2) Carriers of hepatitis viruses or have active HBV/HCV infections
3) History of HBV/HCV infection (excluding cases with negative nucleic acid quantification tests)
4) Severe liver disease (AST or ALT >=100 U/L)
5) Severe kidney disease (serum creatinine >=2mg/dL)
6) Active tuberculosis infection
7) Current or history of malignant tumors (excluding cases with no recurrence for more than 5 years, and cervical cancer treated with only with local therapy that remaining in situ and no metastasis for more than 3 years)
8) Suspected active infection
9) Pregnant or may be pregnant female
10) Lactating female
11) Coexisting collagen diseases, excluding Sjogren's syndrome and antiphospholipid antibody syndrome
12) Within 30 days after receiving live vaccine administration
13) Participation in the study is determined as unsuitable
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients achieving LLDAS after 12 weeks of anifrolumab initiation.
- Secondary Outcome Measures
Name Time Method Percentage of patients who discontinued PSL after 24 weeks of anifrolumab initiation<br>Percentage of patients achieving LLDAS after 24 weeks of anifrolumab initiation<br>Percentage of achievement of each component of the LLDAS after 12 and 24 weeks of anifrolumab initiation<br>Change from baseline in SLEDAI-2K after 12 and 24 weeks of anifrolumab initiation<br>Change from baseline in complement (C3, C4, CH50) and anti-DNA antibodies after 12 and 24 weeks of anifrolumab initiation<br>Dose and cumulative dose of PSL at 12 and 24 weeks after anifrolumab initiation<br>Percentage of patients receiving concomitant immunosuppressive drugs and when they were initiated<br>Adverse events associated with anifrolumab<br>Exploratory evaluation of the relationship between the expression level of IFN signature genes, lymphocyte subsets, changes in blood cytokines, etc. and the activity of SLE and response to therapy at baseline, 0, 12, and 24 weeks