E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriatic Arthritis |
Artrite Psoriasica |
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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] - Musculoskeletal Diseases [C05] |
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 guselkumab efficacy vs placebo in patients with active psoriatic arthritis (PsA) and an inadequate response to anti-TNFa therapy by assessing the reduction in signs and symptoms of joint disease. |
L’obiettivo primario di questo studio è valutare l’efficacia di guselkumab rispetto al placebo nei pazienti con artrite psoriasica attiva (PsA) e risposta inadeguata alla terapia anti-TNFa tramite valutazione della riduzione di segni e sintomi di malattie articolari. |
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E.2.2 | Secondary objectives of the trial |
- Efficacy in improving physical function
- Efficacy in improving general and disease-specific health-related quality of life and patient-reported health outcomes
- Efficacy in improving psoriatic skin lesions
- Safety |
- Efficacia per il miglioramento della funzione fisica - Efficacia per il miglioramento della qualità della vita correlata alla salute in generale e specificamente in relazione alla malattia, nonché degli esiti sulla salute riferiti dal paziente - Efficacia per il miglioramento delle lesioni cutanee dovute alla psoriasi - Sicurezza |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Be a man or a woman at least 18 years of age
2. Have a diagnosis of PsA for at least 6 months before the first administration of study intervention and meet Classification criteria for Psoriatic ARthritis at screening.
3. Have active PsA as defined by at least 3 swollen joints and at least 3 tender joints at screening and at baseline.
4. Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.
5. Have active plaque psoriasis, with at least one psoriatic plaque of =2 cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis.
6. Have an inadequate response to anti-TNFa therapy, defined as presence of active PsA despite previous treatment with either 1 or 2 anti-TNFa agents and either of the following:
a. Lack of benefit of an anti-TNFa therapy, as documented in the patient history by the treating physician, after at least 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy (or biosimilar) and/or at least a 14-week dosage regimen (ie, at least 4 doses) of infliximab (or biosimilar). Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity
b. Intolerance to an anti-TNFa therapy, as documented in the patient history by the treating physician, to etanercept, adalimumab, golimumab, certolizumab pegol, or infliximab (or biosimilars)
For a complete overview of the inclusion criteria please refer to protocol section 5.1 (pages 25-29) |
1. Essere uomo o donna con almeno 18 anni di età 2. Avere una diagnosi di Artrite Psoriasica da almeno 6 mesi dalla prima somministrazione del farmaco in studio e soddisfare i criteri di classificazione per l’artrite psoriasica (CASPAR) allo screening 3. Avere una Artrite psoriasica attiva definita dalla presenza di almeno 3 articolazioni gonfie e 3 articolazioni dolenti allo screening e al baseline 4. Avere almeno 1 delle 5 forme di artrite Psoriasica: con coinvolgimento delle piccole articolazioni inter-falangee distali, artrite poliarticolare con assenza di noduli reumatoidi, artrite periferica asimmetrica o spondilite con artrite periferica 5. Avere una psoriasi a placche attiva con almeno una placca psoriasica =2 cm di diametro o coinvolgimento delle unghie consistente con la psoriasi o storia documentata di psoriasi a placche. 6. Avere una risposta inadeguata a una terapia con anti TNF alfa definita come presenza di artrite psoriasica attiva nonostante un precedente trattamento con 1 o 2 agenti anti TNF alfa e uno dei seguenti: a. mancanza di beneficio da una terapia con anti TNF alfa, documentata dalla storia medica del paziente, dopo almeno 12 settimane di trattamento con etanercept, adalimumab, golimumab, or certolizumab pegol (o biosimilari) e/o almeno 14 settimane di regime con Infliximab o biosimilari (almeno 4 dosi). La mancanza di beneficio documentata può includere un inadeguato miglioramento nella conta articolare, nelle funzioni fisiche o nella attività della malattia b. Intolleranza alla terapia con anti TNF alfa, documentata nella storia medica del paziente a etanercept, adalimumab, golimumab, certolizumab pegol, o infliximab (o biosimilari)
Per una completa lista dei criteri di inclusione si prega di consultare il protocollo alla sezione 5.1 |
|
E.4 | Principal exclusion criteria |
1. Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to RA, axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease
2. Has ever received more than 2 anti-TNFa agents
3. Has received an anti-TNFa agent (see page 30 of the protocol for a description of the anti-TNFa agents)
4. Has previously been treated with guselkumab.
5. Has previously received any biologic treatment, including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment.
For a complete overview of the exclusion criteria please refer to protocol section 5.2 (pages 30-33) |
1. Avere altre malattie infiammatorie che possono confondere la valutazione dei benefici della terapia con Guselkumab, incluso ma non limitato ad artrite reumatoide, spondiloartrite assiale, lupus eritematoso sistemico, malattia di Lyme 2. Aver ricevuto più di 2 agenti anti TNF alfa 3. Aver ricevuto un agente anti TNF alfa nelle tempistiche precedenti all’arruolamento in protocollo descritte a pagina 30 4. Aver ricevuto precedentemente Guselkumab. 5. Aver ricevuto precedentemente un trattamento biologico tra cui: ustekinumab, abatacept, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab, o altri trattamenti biologici sperimentali.
Per una completa lista dei criteri di esclusione si prega di consultare il protocollo alla sezione 5.2 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The Proportion of participants who achieve an American College of Rheumatology (ACR) 20 response |
Proporzione di partecipanti con risposta pari a 20 secondo i criteri dell’American College of Rheumatology (ACR) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1. Change from baseline in Health Assessment Questionnaire-Disability Index score 2. Proportion of participants who achieve an ACR 50 response 3. Change from baseline in 36-item short form health survey Physical Component Summary score 4. Proportion of participants who achieve Psoriatic Area and Severity Index 100 response among participants with major or equal 3% body surface area psoriatic involvement and an Investigator’s Global Assessment score of major or equal 2 at baseline |
1.Cambiamento rispetto alla baseline del punteggio dell’indice di disabilità del questionario di valutazione della salute (HAQ-DI) 2.Proporzione di partecipanti con risposta ACR 50 3.Cambiamento rispetto alla baseline del punteggio della sintesi dei componenti fisici (PCS) ottenuto col questionario SF-36v2 (36-item short form health survey) 4.Proporzione di partecipanti con risposta 100 nell’indice dell’area e della gravità della psoriasi (PASI) fra i partecipanti con area di superficie corporea interessata dalla psoriasi > o=3% e punteggio di valutazione globale dello sperimentatore (IGA) > o =2 (lieve) alla baseline |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 138 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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
|
|
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 | 7 |
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 | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |