Steroid withdrawal in SLE
Key facts
- Where
- Brescia, Cagliari, Ferrara, Milan és Pisa, OlaszországSee the 5 sites
- Phase
- 4. fázis
Where in Olaszország
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, OlaszországTaking people
- Azienda Ospedaliero - Universitaria di CagliariCagliari, OlaszországTaking people
- University Hospital Of FerraraFerrara, OlaszországTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, OlaszországTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, OlaszországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Azienda Ospedaliero Universitaria Pisana
- Trial code
- EU 2024-518580-35-00
- Record updated
- 2025. november 19.
- Original description
To test whether in SLE patients, who are in LLDAS and on background standard-of-care (SoC) therapy, GC withdrawal is non-inferior to low GC dose maintenance for maintaining LLDAS at 36 months of follow-upRead full original descriptionShow less
TARGETing steroid withdrawal in SLE (TARGET2020 STUDY): a pragmatic, randomized, phase IV, open-label, non-inferiority trial
To test whether in SLE patients, who are in LLDAS and on background standard-of-care (SoC) therapy, GC withdrawal is non-inferior to low GC dose maintenance for maintaining LLDAS at 36 months of follow-up
Inclusion: Type of Patient and Disease Characteristics [1] Are at least 18 years of age to 75 years. [2] Are classified as having SLE according to the EULAR/ACR 2019 criteria [3] Have stable immunosuppressive treatment for SLE for a minimum of 4 months. [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 [5] Have a stable treatment with antimalarials for SLE (unless contraindicated or not tolerated) for a minimum of six months. [6] have a proven adherence to HCQ (defined as blood levels ≥500 ng/mL at screening) [7] signed informed consent.
Exclusion: Have a concomitant ongoing condition (e.g. asthma, Crohn’s disease) that require treatment with systemic GC (excluding topical or inhaled GC). 11. Not being on antimalarials 12. History of poor adherence to antimalarials 13. Have a concomitant, uncontrolled fibromyalgia with chronic pain (VAS score >7 on a 1-10 scale) 14. Are nursing mothers, pregnant women or women planning to become pregnant during the study. 15. History (either by medical record or subject interview) of intolerance or a contraindication antimalarials. 16. In the opinion of the investigator, are at an unacceptable risk for participating in the study 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). 18. Are unable or unwilling to make themselves available for the duration of the study and/or are unwilling to follow study restrictions/procedures.