JPRN-jRCTs031230358
Recruiting
N/A
Exploratory study for the usefulness of early introduction of anifrolumab in the first remission induction therapy for systemic lupus erythematosus
Tsuboi Hiroto0 sites10 target enrollmentSeptember 22, 2023
Conditionssystemic lupus erythematosus
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- systemic lupus erythematosus
- Sponsor
- Tsuboi Hiroto
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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