PREDNISONE for Systemic Lupus Erythematosus

Inclusion criteria

• {"criterion_text":"- Type of Patient and Disease Characteristics [1] Are at least 18 years of age to 75 years."}
• {"criterion_text":"- [2] Are classified as having SLE according to the EULAR/ACR 2019 criteria"}
• {"criterion_text":"- [3] Have stable immunosuppressive treatment for SLE for a minimum of 4 months."}
• {"criterion_text":"- [4] Fulfilling criteria for a minimum of 6 months prior to the screening visit of the “modified LLDAS” defined as follow: a) SLEDAI-2K≤4 (total, including serology), with no activity in major organ systems (renal, central nervous system, cardiopulmonary, vasculitis and fever) and no haemolytic anaemia or gastrointestinal activity; b) no new features of lupus disease activity compared with the previous assessment; c) PhGA (0–3)≤1; d) well-tolerated standard maintenance dosages of immunosuppressive drugs and approved biologics. e) Have a stable treatment with prednisone (or equivalent) dosage≤5 mg/day for a minimum of 6 months"}
• {"criterion_text":"- [5] Have a stable treatment with antimalarials for SLE (unless contraindicated or not tolerated) for a minimum of six months."}
• {"criterion_text":"- [6] have a proven adherence to HCQ (defined as blood levels ≥500 ng/mL at screening)"}
• {"criterion_text":"- [7] signed informed consent"}

Exclusion criteria

• {"criterion_text":"- 10. Have a concomitant ongoing condition (e.g. asthma, Crohn’s disease) that require treatment with systemic GC (excluding topical or inhaled GC)."}
• {"criterion_text":"- 11. Not being on antimalarials"}
• {"criterion_text":"- 12. History of poor adherence to antimalarials"}
• {"criterion_text":"- 13. Have a concomitant, uncontrolled fibromyalgia with chronic pain (VAS score >7 on a 1-10 scale)"}
• {"criterion_text":"- 14. Are nursing mothers, pregnant women or women planning to become pregnant during the study."}
• {"criterion_text":"- 15. History (either by medical record or subject interview) of intolerance or a contraindication antimalarials."}
• {"criterion_text":"- 16. In the opinion of the investigator, are at an unacceptable risk for participating in the study"}
• {"criterion_text":"- 17. Have a history of intravenous drug abuse, other illicit drug abuse, or chronic alcohol abuse within the 2 years prior to screening or are concurrently using, or expected to use during the study, illicit drugs (including marijuana)."}
• {"criterion_text":"- 18. Are unable or unwilling to make themselves available for the duration of the study and/or are unwilling to follow study restrictions/procedures"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients maintaining modified LLDAS for 100% of the follow-up period (36 months) even after glucocorticoid withdrawal","definition_or_measurement_approach":"Measured as the proportion of patients maintaining the protocol-defined modified LLDAS for the entire 36-month follow-up period. Modified LLDAS definition referenced in inclusion criteria: SLEDAI-2K≤4 (total, including serology), no activity in major organ systems, no haemolytic anaemia or gastrointestinal activity; no new features of lupus disease activity compared with previous assessment; PhGA (0–3)≤1; well-tolerated maintenance dosages of immunosuppressives/approved biologics; stable prednisone (or equivalent) ≤5 mg/day for minimum 6 months."}

Secondary endpoints

• {"endpoint_text":"- o Proportion of patients who maintain modified LLDAS for 100% of the visits at 12, 24 and 36 months","definition_or_measurement_approach":"Measured as the proportion of patients maintaining modified LLDAS at all scheduled visits at 12, 24 and 36 months."}
• {"endpoint_text":"- o Proportion of patients who maintain remission on treatment for 100% of the visits at 12, 24 and 36 months","definition_or_measurement_approach":"Measured as the proportion of patients who are in remission on treatment at all scheduled visits at 12, 24 and 36 months."}

Italy

Earliest CTIS Part Ii Submission Date

30-09-2024

Latest Decision Or Authorization Date

19-11-2025

Processing Time Days

415

Number Of Sites

5

Number Of Participants

252

Primary sponsor

Full Name

Azienda Ospedaliero Universitaria Pisana

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy