Systemic Lupus Eritematosus (SLE) MedDRA version: 21.1 Level: LLT Classification code 10042944 Term: Systemic lupus erythematosis System Organ Class: 100000004859
Conditions
Interventions
Product Name: prednisone
Product Code: [NA]
Pharmaceutical Form: Tablet
INN or Proposed INN: PREDNISONE
Current Sponsor code: NA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible to be included in the study only if they meet all the following criteria: 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 232 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 10. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 1.To evaluate the effect of GC withdrawal compared with low GC dose maintenance on SLE disease activity at 12 and 24 months of follow-up 2.To evaluate the effect of GC withdrawal compared with low GC dose maintenance on disease flares by 12, 24 and 36 months 3.To evaluate the effect of GC withdrawal compared with low GC dose maintenance in Systemic Lupus International Collaborative Clinics/American College of Rheumatology (SLICC/ACR) damage index total score at 12, 24 and 36 months. 4.To evaluate and compare quality of life of patients achieving GC withdrawal compared with those in low GC dose maintenance using both disease specific (LIT, LupusQOL) and general questionnaires (FACIT, EQ-5D-3L, SF-36) at 12, 24 and 36 months. 5.To evaluate cost and the cost-effectiveness of GC withdrawal compared with low GC dose maintenance from both the perspective of the National Health System and the Society.;Primary end point(s): Proportion of patients maintaining modified LLDAS for 100% of the follow-up period (36 months), where modified LLDAS is defined as: (1) SLE Disease Activity Index (SLEDAI)-2K =4, with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) and no haemolytic anaemia or gastrointestinal activity; (2) no new lupus disease activity compared with the previous assessment; (3) a physician global assessment (scale 0– 3) =1; (4) well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents (5) daily glucocorticoid dosage =5 mg prednisone equivalent;Timepoint(s) of evaluation of this end point: 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): o Proportion of patients who maintain modified LLDAS for 100% of the visits at 12 and 24 months o Proportion of patients who maintain clinical remission on treatment for 100% of the visits at 12, 24 and 36 months defined as: (1) clinical SLEDAI-2K = 0; (2) physician’s global assessment <0.5 (on a 0–3 scale) (3) maintenance antimalarials, maintenance immunosuppressives and/or stable (maintenance) biologics (4) low dose of GC (prednisone =5 mg/day) o Proportion of patients who maintain complete remission on treatment for 100% of the visits at 12, 24 and 36 months defined as: (1) SLEDAI-2K = 0; (2) physician’s global assessment being <0.5 (on a 0–3 scale) (3) maintenance antimalarials, maintenance immunosuppressives and/or stable (maintenance) biologics (4) low dose of GC (prednisone =5 mg/day) o Cumulative incidence of patients fulfilling severe flare criteria at 12, 24 and 36 months (see Appendix 1 for definitions of severe flares) o Cumulative incidence of patients fulfilling mild-moderate flare criteria at 12, 24 and 36 months (see Appendix 1 for definitions of mild-moderate flares) o Change from baseline in FACIT-Fatigue scale at 12, 24 and 36 months o Change from baseline in mental component score (MCS), physical component score (PCS), and domain scores in the Short-Form 36-item health survey version (SF-36) at 12, 24 and 36 months o Change from baseline in Eq-5d at 12, 24 and 36 months o Change from baseline in Systemic Lupus Erythematosus Steroid Questionnaire (SSQ) at 12, 24 and 36 months o Change from baseline in Lupus Impact Tracker (LIT) at 12, 24 and 36 months o Change from baseline in SLICC/ACR at 12, 24, 36 months o Direct and indirect costs;Timepoint(s) of evaluation of this end point: 3 months | — |
Countries
European Union, Italy
Contacts
Public ContactU.O. Reumatologia Universitaria
Azienda Ospedaliero Universitaria Pisana
Outcome results
None listed