E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active Psoriatic Arthritis |
Artrite Psoriasica Attiva |
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E.1.1.1 | Medical condition in easily understood language |
Psoriatic Arthritis |
Artrite Psoriasica |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of guselkumab+golimumab combination treatment in participants with active PsA and IR to a prior anti-TNFa therapy by assessing clinical response compared with guselkumab monotherapy |
Valutare l’efficacia del trattamento di combinazione con guselkumab+golimumab in partecipanti con PsA attiva e risposta inadeguata (Inadequate Response, IR) a una precedente terapia con fattore di necrosi tumorale a (TNFa) valutando la risposta clinica rispetto alla monoterapia con guselkumab |
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E.2.2 | Secondary objectives of the trial |
- Efficacy: To evaluate the efficacy of guselkumab+golimumab combination treatment in participants with active PsA and IR to a prior anti-TNFa therapy by assessing the reduction in signs and symptoms of PsA compared with guselkumab monotherapy - Safety: To evaluate the safety of guselkumab+golimumab combination treatment in participants with active PsA compared with guselkumab monotherapy - PK and Immunogenicity: To evaluate the PK and immunogenicity of guselkumab+golimumab combination treatment in participants with active PsA compared with guselkumab monotherapy |
• Efficacia: Valutare l’efficacia del trattamento di combinazione con guselkumab+golimumab in partecipanti con PsA attiva e IR a una precedente terapia anti-TNFa valutando la riduzione dei segni e dei sintomi di PsA rispetto alla monoterapia con guselkumab • Sicurezza: Valutare la sicurezza del trattamento di combinazione con guselkumab+golimumab in partecipanti con PsA attiva rispetto alla monoterapia con guselkumab • PK e immunogenicità: Valutare la farmacocinetica (PK) e l’immunogenicità del trattamento di combinazione con guselkumab+golimumab in partecipanti con PsA attiva rispetto alla monoterapia con guselkumab |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Other types of substudies Specify title, date and version of each substudy with relative objectives: Initial Clinical Protocol, 08 June 21, version 1.0. Biopsies from lesional and nonlesional skin may be collected from participants who consent to this optional substudy component of the study (with a separate ICF), as fixed blocks, slides, fresh or frozen samples, where local regulations permit
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Altre tipologie di sottostudi specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Protocollo clinico iniziale, 08 giugno 21, versione 1.0. Le biopsie della pelle lesionata e non lesionata possono essere raccolte dai partecipanti che acconsentono a questo sottostudio facoltativo componente dello studio (con un ICF separato), come blocchi fissi, vetrini, campioni freschi o congelati, ove le normative locali lo consentano
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E.3 | Principal inclusion criteria |
- Be =18 to =65 years of age, inclusive. - Medically stable on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and initialed by the investigator. - Have a diagnosis of PsA for =6 months prior to the first administration of study intervention and meet ClASsification criteria for Psoriatic ARthritis criteria at screening. - Have active PsA as defined by: At least 3 swollen joints and at least 3 tender joints at screening and at baseline and, hsCRP =0.3 mg/dL at screening from the central laboratory - Have at least 1 of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.
For the complete overview of the inclusion criteria, please refer to section 5.1 of the protocol |
- Avere da =18 a =65 anni di età inclusi. - Stabili dal punto di vista medico sulla base dell'esame obiettivo, dell'anamnesi, dei segni vitali e dell'ECG a 12 derivazioni eseguito allo screening. Eventuali anomalie devono essere coerenti con la malattia sottostante nella popolazione dello studio e questa determinazione deve essere registrata nei documenti di origine del partecipante e siglata dallo sperimentatore. - Avere una diagnosi di PsA per = 6 mesi prima della prima somministrazione dell'intervento in studio e soddisfare i criteri di classificazione per i criteri di artrite psoriasica allo screening. - Avere PsA attivo come definito da: Almeno 3 articolazioni gonfie e almeno 3 articolazioni dolenti allo screening e al basale e hsCRP = 0,3 mg/dL allo screening dal laboratorio centrale - Avere almeno 1 dei seguenti sottogruppi di PsA: coinvolgimento dell'articolazione interfalangea distale, artrite poliarticolare con assenza di noduli reumatoidi, artrite periferica asimmetrica o spondilite con artrite periferica.
Per la panoramica completa dei criteri di inclusione, fare riferimento alla sezione 5.1 del protocollo |
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E.4 | Principal exclusion criteria |
- Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal insufficiency, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, genitourinary, or metabolic disturbances. - Has unstable cardiovascular disease, defined as a recent clinical deterioration in the last 3 months prior to screening or a cardiac hospitalization within the last 3 months prior to screening. - Has a history of, or concurrent, congestive heart failure, including medically controlled, asymptomatic congestive heart failure. - Has a history of a demyelinating disorder such as multiple sclerosis or optic neuritis. - Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab and/or golimumab therapy, including but not limited to RA, AS, nr-AxSpA, systemic lupus erythematosus, or lyme disease.
For the complete overview of the exclusion criteria, please refer to section 5.2 of the protocol |
- Ha una storia o segni o sintomi attuali di insufficienza renale grave, progressiva o incontrollata, disturbi epatici, cardiaci, vascolari, polmonari, gastrointestinali, endocrini, neurologici, ematologici, reumatologici, psichiatrici, genitourinari o metabolici. - Ha una malattia cardiovascolare instabile, definita come un recente deterioramento clinico negli ultimi 3 mesi prima dello screening o un ricovero cardiaco negli ultimi 3 mesi prima dello screening. - Ha una storia di, o concomitante, insufficienza cardiaca congestizia, inclusa insufficienza cardiaca congestizia, asintomatica controllata dal punto di vista medico. - Ha una storia di un disturbo demielinizzante come la sclerosi multipla o la neurite ottica. - Presenta altre malattie infiammatorie che potrebbero confondere le valutazioni del beneficio della terapia con guselkumab e/o golimumab, inclusi ma non limitati a RA, AS, nr-AxSpA, lupus eritematoso sistemico o malattia di Lyme.
Per la panoramica completa dei criteri di esclusione, fare riferimento a sezione 5.2 del protocollo |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of participants who achieve MDA at Week 24 |
Percentuale di partecipanti che ottengono MDA alla settimana 24 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Proportion of participants who achieve ACR 50 at Week 24 - Proportion of participants who achieve MDA at Week 16 - Proportion of participants who achieve Psoriasis Area and Severity Index 90/100 at Week 24 among the participants with =3% BSA psoriatic involvement and an IGA score of =2 at baseline - Proportion of participants with an Investigator Global Assessment-psoriasis response at Week 24 among participants with =3% BSA psoriatic involvement and an IGA score of =2 at baseline - Change from baseline in Health Assessment Questionnaire Disability Index at Week 24 - Resolution of enthesitis at Week 24 among the participants with enthesitis at baseline - Resolution of dactylitis at Week 24 among the participants with dactylitis at baseline - Change from baseline in Short Form Health Survey Physical Component Score (PCS) at Week 24 |
- Percentuale di partecipanti che raggiungono ACR 50 alla Settimana 24 - Percentuale di partecipanti che ottengono MDA alla Settimana 16 - Percentuale di partecipanti che raggiungono l'area psoriasica e l'indice di gravità 90/100 alla settimana 24 tra i partecipanti con coinvolgimento psoriasico BSA = 3% e un punteggio IGA di = 2 al basale - Percentuale di partecipanti con una risposta Investigator Global Assessment-psoriasi alla settimana 24 tra i partecipanti con coinvolgimento psoriasico BSA = 3% e un punteggio IGA di = 2 al basale - Modifica rispetto al basale dell'indice di disabilità del questionario di valutazione della salute alla settimana 24 - Risoluzione dell'entesite alla settimana 24 tra i partecipanti con entesite al basale - Risoluzione della dattilite alla settimana 24 tra i partecipanti con dattilite al basale - Modifica rispetto al basale del punteggio della componente fisica (PCS) dell'indagine sulla salute in forma abbreviata alla settimana 24 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 16 and 24 |
settimana 16 e 24 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
MRI, Biomarker and Immunogenicity assessments |
MRI, biomarcatori e valutazioni di immunogenicità |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 75 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
United States |
France |
Poland |
Sweden |
Spain |
Czechia |
Germany |
Italy |
Denmark |
Hungary |
Russian Federation |
Ukraine |
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E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |