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    Summary
    EudraCT Number:2020-002052-21
    Sponsor's Protocol Code Number:NCT03804723
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-12
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-002052-21
    A.3Full title of the trial
    TARGETing steroid withdrawal in SLE (TARGET2020 STUDY): a randomized, phase IV, open -label, non-inferiority trial
    Sospensione degli steroidi nel SLE (STUDIO TARGET2020): uno studio di non inferiorità randomizzato, di fase IV, in aperto.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Glucocorticoid scaling and withdrawal in Systemic Lupus Eritematosus treatment
    Riduzione ed eliminazione della terapia con glucocorticoidi nel trattamento del Lupus Eritematoso Sistemico
    A.3.2Name or abbreviated title of the trial where available
    TARGET2020
    TARGET2020
    A.4.1Sponsor's protocol code numberNCT03804723
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAzienda Ospedaliero Universitaria Pisana
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliero Universitaria Pisana
    B.5.2Functional name of contact pointU.O. Reumatologia Universitaria
    B.5.3 Address:
    B.5.3.1Street AddressVia Roma, 67
    B.5.3.2Town/ cityPisa
    B.5.3.3Post code56126
    B.5.3.4CountryItaly
    B.5.4Telephone number0502218290
    B.5.5Fax number0502210625
    B.5.6E-mailmarta.mosca@med.unipi.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameprednisone
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISONE
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Systemic Lupus Eritematosus (SLE)
    Lupus Eritematoso Sistemico (LES)
    E.1.1.1Medical condition in easily understood language
    Systemic Lupus Eritematosus (SLE)
    Lupus Eritematoso Sistemico (LES)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10042944
    E.1.2Term Systemic lupus erythematosis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the 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.
    L’obiettivo primario è quello di verificare se, in pazienti con LES che sono in stato di bassa attività di malattia (LLDAS) e in trattamento con la terapia standard di background, l’eliminazione dei GC rappresenta un trattamento non inferiore rispetto alla terapia con GC a basso dosaggio, nel mantenimento dell’LLDAS a 36 mesi.
    E.2.2Secondary objectives of the trial
    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.
    1. valutare effetto della sospens. dei GC confrontato con una bassa dose di mantenimento sull'attività del LES a 12 e 24 mesi di follow up
    2. valutare effetto della sospens. dei GC confrontato con una bassa dose di mantenimento, sulle riacutizzazioni di malattia a 12, 24 e 36 mesi
    3. valutare effetto della sospens. di GC rispetto al mantenimento di una dose bassa di GC nel punteggio totale dell'indice di danno Systemic Lupus International Collaborative Clinics / American College of Rheumatology (SLICC / ACR) a 12, 24 e 36 mesi
    4. valutare e comparare qualità di vita dei pazienti che hanno raggiunto la sospens. del trattamento con GC rispetto a pz. che continuano la terapia a basse dosi utilizzando sia questionari specifici (LIT, LupusQoL) e generali (FACIT, EQ-5D-3L, SF-36) a 12, 24 e 36 mesi;
    5. valutare costi e rapporto costo-efficacia della sospens. dei GC rispetto al mantenimento della terapia a basse dosi di GC sia dal punto di vista del SSN che dal punto di vista della società.
    E.2.3Trial contains a sub-study No
    E.3Principal 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)
    I pazienti sono eleggibili ad essere inclusi nello studio solamente se sono ripsettati tutti i seguenti criteri:
    1. età compre sa tra 18 e 75 anni;
    2. sono stati classificati come pasienti con LES secondo i criteri EULAR/ACR
    3. Utilizzare un trattamento immunosopressivo per il LES per almeno 4 mesi;
    4. Soddisfare i criteri per un minimo di 6 mesi prima della visita di screening del "LLDAS modificato" definito come segue:
    a) SLEDAI-2K=4 ( totale, inclusa la sierologia), senza attività negli organi dei sistemi maggiori ( renale, Sistema nercoso centrale, cardiopolmonare, vasculit e efebbre) e nessuna anemia emolitica o attività a livello gastrointestinale;
    b) nessuna nuovo tratto dell'attività di LES rispetto alla valutazione precedente;
    c) PhGA (0–3)=1;
    d) dosaggi standard di mantenimento con farmaci immunoppressivi o biologici ben tollerati
    e) trattamento stabile con prednisone ( o faramco equivalente) al dosaggio minore o uguale a 5 mg/die per un periodo minimo di 6 mesi;
    5. trattamento stabile con antimalarici indicati per il trattamento del LES ( se nno mal tollerati o controindicati) per un minimo di 6 mesi;
    6. 11. hanno una comprovata adesione all'HCQ (definito come livelli ematici 500 ng/mL allo screening).
    E.4Principal 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
    10. presenza di condizioni concomitanti ( es. asma, morbo di Chron) che richiedono trattamenti con glucocorticoidi sistemici ( con l'esclusione delle formulazioni topiche ed inalatorie);
    11. non sono in terapia con antimalarici;
    12. storia di scarsa aderenza agli antimalarici;
    13. concomitante fibromialgia non controllata con dolore cronico ( punteggio VAS >7 in una scala da 1 a 10);
    14. donne in allattamento, in gravidanza o donne che stanno pianificando una gravidanza;
    15. storia di intolleranza o controindicazione agli antimalarici ( sia da cartella clinica che tramite intervista);
    16. secondo il parere dello sperimentatore , la partecipazone allo studio comporta un rischio inaccettabile;
    17. storia di abuso di droghe per via endovenosa, altri abusi illeciti di droghe, abuso cronico di alcool entro due anni prima dello screening o attualmente in corso, o che ci sia sperta che ne facciano uso durante lo studio, droghe illecite ( compre marijuana);
    18. Non sono in grado o non vogliono rendersi disponibili per la durata dello studio e / o non sono disposti a seguire le restrizioni / procedure dello studio
    E.5 End points
    E.5.1Primary 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
    Proporzione di pazienti che mantengono LLDAS modificato per il 100% del periodo di follow-up (36 mesi), in cui IL LLDAS modificato è definito come:
    1) SLE Disease Activity Index (SLEDAI)-2K =4, senza alcuna attività negliprincipali sistemi d'organi ( renali, SNC, cardipolmonare, vasculite, febbre) assenza di anemia emolitica o attività a livello gastrointestinale;
    2) nessuna nuova attività di malattia del lupus rispetto alla valutazione precedente;
    3) valutazione medica globale ( scala da 0 a 3)=1
    4) buona tolleranza delle dosi standard di manetenimento di farmaci iinnusoppressivi e farmaci biologici approvati;
    5) dosaggio giornaliero di glucocorticoide= 5 mg di prednisone o equivalente
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 months
    36 mesi
    E.5.2Secondary 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
    - percentuale di pazienti che mantendono LLDAS modificata per il 100% delle visite a 12 e 24 mesi
    -percentuale di pazienti che mantengono la remissione clinica sul trattamento per il 100% delle vistr a 12, 24 e 36 mesi definito come:
    1) SLEDAI-2K clinico= 0
    2) valutazione globale del medico <0.5 su un scala da 0 a 3);
    3) antimalarici di mantenimento, immunosoppressori di mantenimento e/o biologici stabili (mantenimento);
    4) basso dosaggio di glucocorticoide (prednisone = 5 mg/die)
    - Incidenza cumulativa di pazienti che soddisfano i criteri di riacutizzazione grave a 12, 24 e 36 mesi ( vedi Appendice 1 per la definizione di riacutizzazione severa)
    - Incidenza cumulativa di pazienti che soddisfano i criteri di riacutizzazione lieve-moderata a 12, 24 e 36 mesi (vedi Appendice 1 per al definizioe di riacutizzazione da lieve a moderata);
    - Variazione rispetto alla visita di baseline nella scala FACIT-Fatigue a 12, 24 e 36 mesi;
    - Variazione rispetto al basale del punteggio della componente mentale (MCS), del punteggio della componente fisica (PCS) e dei punteggi di dominio nella versione del sondaggio sulla salute a 36 voci (SF-36) a 12, 24 e 36 mesi;
    - Variazione rispetto al basale nell'Eq-5d a 12, 24 e 36 mesi;
    - Variazione rispetto al basale nel questionario sugli steroidi sistemici per il lupus eritematoso (SSQ) a 12, 24 e 36 mesi
    - Variazione rispetto al basale in Lupus Impact Tracker (LIT) a 12, 24 e 36 mesi
    - Variazione rispetto al basale di SLICC / ACR a 12, 24, 36 mesi
    - Costi diretti ed indiretti
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months
    36 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 232
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 252
    F.4.2.2In the whole clinical trial 252
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will continue to have background therapy (SoC) and will be treated as per clinical practice
    I pazienti continueranno ad avere la terapia di background (SoC) e saranno trattati come da pratica clinica
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-24
    P. End of Trial
    P.End of Trial StatusOngoing
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