Taking people in ItalyPhase 4
Stopping steroids versus keeping a low dose in lupus
Tests stopping steroids against a low dose in adults with lupus doing well.
Key facts
- Who runs it
- Azienda Ospedaliero Universitaria Pisana
- Where
- Brescia, Cagliari, Ferrara, Milan, and Pisa, ItalySee the 5 sites
- Registry title
- Steroid withdrawal in SLE
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 252 people, planned
- Started
- 20 Nov 2024
- Expected to end
- 5 Mar 2028
- Type of study
- Interventional
- Record updated
- 19 November 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with lupus (SLE) whose disease has been quiet for at least 6 months on stable treatment. It tests stopping steroids against keeping a low steroid dose.
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Lupus (SLE) that meets the 2019 EULAR/ACR criteria. The disease must have been in low activity (modified LLDAS) for at least 6 months, with no activity in major organs.
- Earlier treatment
- Stable immunosuppressive treatment for at least 4 months. Prednisone (or equivalent) at 5 mg/day or less for at least 6 months. Stable antimalarial treatment for at least 6 months.
- Biomarker or test result
- Hydroxychloroquine (HCQ) blood level of at least 500 ng/mL at screening.
Main reasons for not taking part
- Another condition that needs systemic steroids, such as asthma or Crohn's disease
- Not taking antimalarials, poor past adherence to them, or intolerance or a contraindication to them
- Uncontrolled fibromyalgia with chronic pain (VAS score above 7 out of 10)
- Pregnant, nursing, or planning pregnancy during the study
- Drug abuse or chronic alcohol abuse in the 2 years before screening
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in Italy
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyTaking people
- Azienda Ospedaliero - Universitaria di CagliariCagliari, ItalyTaking people
- University Hospital Of FerraraFerrara, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
About the trial
What the trial wants to find out
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
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?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- TARGETing steroid withdrawal in SLE (TARGET2020 STUDY): a pragmatic, randomized, phase IV, open-label, non-inferiority trial
- Plain-language title
- Stopping steroids versus keeping a low dose in lupusGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 19 November 2025