Exploratory study for the usefulness of early introduction of anifrolumab in the first remission induction therapy for systemic lupus erythematosus

Recruiting

• Conditions: systemic lupus erythematosus

• Registration Number: jRCTs031230358

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-22
• Study Start: 2023-12-26
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 10

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
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: single assignment

Primary Outcome Measures

Name	Time	Method
-		Percentage of patients achieving LLDAS after 12 weeks of anifrolumab initiation.