E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Arthritic Psoriasis |
Artrite psoriatica |
|
E.1.1.1 | Medical condition in easily understood language |
A type of arthritis associated with psoriasis |
Un tipo di artrite associata alla psoriasi |
|
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 | 18.0 |
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 |
Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis who are biologic disease-modifying antirheumatic drugs (bDMARD0-experienced, as measured by the percentage of patients achieving ACR20 response at Week 24. |
Efficacia di ixekizumab rispetto a placebo nel trattamento di pazienti con artrite psoriasica (AP) attiva che hanno esperienza con bDMARD, misurando la percentuale di pazienti che raggiungono una risposta secondo il criterio 20 del Collegio americano di reumatologia (American College of Rheumatology, ACR20) alla Settimana 24. |
|
E.2.2 | Secondary objectives of the trial |
• Efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis based on ACR20 through 24 Weeks • Efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis based on Non-Arthritic Disease Assessments through 24 Weeks • Efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis based on Patient Reported Outcomes (PROs) through 24 Weeks
|
Efficacia di ixekizumab rispetto al placebo nei pazienti con artrite psoriatica attiva in base ad ACR20 attraverso le 24 settimane • Efficacia di ixekizumab rispetto al placebo nei pazienti con artrite psoriatica attiva sulla base della Non-Arthritic Disease Assessments attraverso le 24 settimane • Efficacia di ixekizumab rispetto al placebo nei pazienti con artrite psoriatica attiva sulla base dei risultati riferiti dai pazienti (PRO) attraversole 24 settimane |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Presents with established diagnosis of active psoriatic arthritis (PSA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria • Active psoriatic arthritis defined as the presence of at least 3 tender and at least 3 swollen joints • Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps) • Men must agree to use a reliable method of birth control or remain abstinent during the study • Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment • Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)
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pazienti con una diagnosi di artrite psoriatica da ≥6 mesi e che attualmente soddisfano i criteri per la classificazione dell’artrite psoriatica (Classification for Psoriatic Arthritis, CASPAR) • Artrite psoriatica attiva definita come la presenza di almeno 3 articolazioni dolenti e 3 articolazioni tumefatte • Presenza di lesioni psoriasiche attive (placche) cutanee o un’anamnesi documentata di psoriasi a placche (Ps). • sono stati trattati con 1 o più cDMARD convenzionali • Gli uomini devono accettare di utilizzare un metodo affidabile di controllo delle nascite o praticare l'astinenza durante lo studio • Le donne devono accettare di utilizzare un metodo affidabile di controllo delle nascite o praticare l'astinenza durante lo studio e per almeno 12 settimane dopo l'interruzione del trattamento |
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E.4 | Principal exclusion criteria |
• Current use of biologic agents for treatment of Ps or PsA • Inadequate response to greater than 2 bDMARDs • Current use of more than one cDMARD • Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA • Have received treatment with IL-17 or IL12/23 targeted MAb therapy • Serious disorder or illness other than psoriatic arthritis • Serious infection within the last 3 months • Breastfeeding or nursing (lactating) women
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L'uso corrente di farmaci biologici per il trattamento di Ps o PSA • risposta inadeguata a più di 2 bDMARDs • L'uso corrente di più di un cDMARD • La diagnosi di sindromi artritiche infiammatorie attive o spondiloartropatie diverse da AP • sono stati trattati con la terapia MAb IL-17 o IL12 / 23 mirata • grave disturbo o malattia diversa da artrite psoriatica • infezioni gravi negli ultimi 3 mesi • L'allattamento al seno |
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E.5 End points |
E.5.1 | Primary end point(s) |
American College of Rheumatology 20 Index (ACR20) |
Risposta secondo il criterio 20 del Collegio americano di reumatologia |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At 24 Weeks |
A 24 settimane |
|
E.5.2 | Secondary end point(s) |
• ACR20 • Non-Arthritic Disease Assessments • Patient Reported Outcomes (PRO) |
• ACR20 • Non-Arthritic Disease Assessments • Patient Reported Outcomes (PRO) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline through 24 Weeks |
Al basale attraverso le 24 settimane |
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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 | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | Yes |
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 | 3 |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 71 |
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 | No |
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 |
Australia |
Czech Republic |
France |
Germany |
Israel |
Italy |
Poland |
Spain |
Taiwan |
United Kingdom |
United States |
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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
|
End of the study is the date of the last visit or the last scheduled procedure for the last active subject in the study whichever is later |
Fine dello studio è la data dell'ultima visita o l'ultima procedura programmata per l'ultimo soggetto attivo nello studio quale si verifichi dopo |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 3 |