Abacavir; Lamivudine for Systemic lupus erythematosus

Inclusion criteria

• {"criterion_text":"- Patient ≥12 years old (weighing more than 25 kg) and ≤ 65 years old"}
• {"criterion_text":"- Diagnosis of LS according to 2019 ACR (American College of rheumatology) / EULAR (European Ligue against Rheumatism) criteria (score >10)"}
• {"criterion_text":"- Patient with LS in remission or with low clinical activity according to LLDAS criteria"}
• {"criterion_text":"- or female patients (including sexually active adolescents) of childbearing age, effective contraception (sexual abstinence, hormonal contraception, intrauterine device or hormone-releasing system, cap, diaphragm or sponge with spermicide, condom) for the entire duration of treatment is required. A pregnancy test will be carried out at inclusion."}
• {"criterion_text":"- Patient affiliated to a social security scheme"}
• {"criterion_text":"- Free, informed and written consent signed by the patient or his/her parents/legal guardian"}

Exclusion criteria

• {"criterion_text":"- History of allergy or hypersensitivity to Abacavir, lamivudine or the excipients (tablet core: microcrystalline cellulose, crospovidone, magnesium stearate, colloidal anhydrous silica, talc; film coating: hypromellose, titanium dioxide (E171), macrogol, polysorbate 80)"}
• {"criterion_text":"- Patients with moderate or severe hepatic impairment (prothrombin level <50%)"}
• {"criterion_text":"- Patient taking part in other interventional research involving medicinal products"}
• {"criterion_text":"- Patients on anti-retroviral treatment"}
• {"criterion_text":"- Patients with chronic HIV, HBV or HCV infection"}
• {"criterion_text":"- Pregnant or breast-feeding woman"}
• {"criterion_text":"- Patient treated with Lamivudine and/or Abacavir"}
• {"criterion_text":"- Patient treated with a cytidine analogue"}
• {"criterion_text":"- Patient receiving treatment containing Cladribine"}
• {"criterion_text":"- Patient receiving treatment containing a trimethoprim/sulphamethoxazole combination (Bactrim)"}
• {"criterion_text":"- Patients with renal impairment (creatinine clearance < 50 ml/min)"}

Primary endpoints

• {"endpoint_text":"- Absolute variation in the interferon (IFN) signature between the start of treatment (M0) and after 6 months of treatment (M6) on the total population (then on the paediatric population then on the adult population). The IFN signature is measured from the transcriptomic expression of 6 IFN-inducible genes (IFI27, IFI44L, IFIT1, ISG15, RSAD2 and SIGLEC)","definition_or_measurement_approach":"The IFN signature is measured from the transcriptomic expression of 6 IFN-inducible genes (IFI27, IFI44L, IFIT1, ISG15, RSAD2 and SIGLEC); change between M0 and M6 is the primary measurement."}

Secondary endpoints

• {"endpoint_text":"- Maintenance of low clinical activity (LLDAS criteria) or remission will be assessed according to : a. The percentage of patients who maintained LLDAS criteria at M6 and M12 in the 2 arms b. the number of relapses and the time to relapse between M0 and M12 (collected continuously)","definition_or_measurement_approach":"Measured as percentage maintaining LLDAS at M6 and M12; number of relapses and time to relapse collected continuously between M0 and M12."}
• {"endpoint_text":"- Evaluation of lupus biomarkers: anti-dsDNA, anti-ENA, C3, C4, CH50 fractions and interferon-α production between M0 and M6 and M0 and M12 in the 2 arms","definition_or_measurement_approach":"Comparison of specified biomarkers (anti-dsDNA, anti-ENA, C3, C4, CH50, interferon-α production) between M0 and M6 and between M0 and M12 in both arms."}
• {"endpoint_text":"- Number of successful patients in each arm. Success is defined as a ≥50% decrease in IFN signature between M0 and M6","definition_or_measurement_approach":"Success defined as ≥50% decrease in IFN signature between M0 and M6; count patients meeting this criterion per arm."}
• {"endpoint_text":"- Cumulative dose of intravenous (IV) and oral corticosteroids from M0 to M6 and from M6 to M12","definition_or_measurement_approach":"Calculate cumulative IV and oral corticosteroid dose from M0–M6 and M6–M12."}
• {"endpoint_text":"- Difference between M0 and M6 and M0 and M12 in Lupus Impact Tracker™ score in the 2 arms","definition_or_measurement_approach":"Change in Lupus Impact Tracker™ score from M0 to M6 and M0 to M12 compared between arms."}
• {"endpoint_text":"- Monitoring of treatment adherence in the 2 arms (follow-up diary + telephone call): number of \"missed\" doses between M0 and M6 and reasons for missed doses.","definition_or_measurement_approach":"Adherence monitored via follow-up diary and telephone call; measure number of missed doses between M0 and M6 and document reasons."}
• {"endpoint_text":"- AEs and SAEs between M0 and M12 in the 2 arms","definition_or_measurement_approach":"Collect and compare adverse events (AEs) and serious adverse events (SAEs) occurring between M0 and M12 in both arms."}
• {"endpoint_text":"- Difference in human endogenous retrovirus (HERV) copy number in the 2 arms at M6 and M12 compared with M0. A comparison between the groups will be carried out","definition_or_measurement_approach":"Measure HERV copy number at M0, M6, M12 and compare changes between arms."}

France

Latest Decision Or Authorization Date

04-06-2025

Number Of Sites

13

Number Of Participants

72

Primary sponsor

Full Name

Hospices Civils De Lyon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France