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 | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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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 demonstrate the efficacy of secukinumab 75 or 150 mg at Week 24 is superior to placebo in patients with active PsA based on the proportion of patients achieving an ACR20 response in the subgroup of subjects who are TNFα inhibitor naïve. |
dimostrare che la proporzione di pazienti che raggiungono i criteri di risposta ACR 20 a 24 settimane è maggiore con secukinumab rispetto al placebo nel sottogruppo di soggetti naïve al trattamento con un inibitore del TNFα. |
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E.2.2 | Secondary objectives of the trial |
• The efficacy of secukinumab 75 or 150 mg at Week 24 is superior to placebo based on the proportion of subjects achieving an ACR20 response in the entire study population. • The improvement (change) from baseline on secukinumab 75 or 150 mg is superior to placebo for the HAQ-DI at Week 24 in the subgroup of subjects who are TNFα inhibitor naïve. • The improvement (change) from baseline to Week 24 on secukinumab 75 and 150 mg is superior to placebo for joint/bone structural damage (van der Heijde modified total Sharp score) in the subgroup of subjects who are TNFα inhibitor naïve. • Secukinumab 75 or 150 mg is superior to placebo (as originally randomized) with regards to the proportion of subjects achieving Major Clinical Response at Week 52 in the subgroup of subjects who are TNFα inhibitor naïve. |
1.La proporzione di pazienti che raggiungono i criteri di risposta ACR 20 a 24 sett. è maggiore con secukinumab rispetto al placebo nell’intera popolazione di studio. 2. Il miglioramento(variazione)rispetto al basale con secukinumab è superiore al placebo nella valutazione HAQ-DI dopo 24 sett. di trattamento nel sottogruppo di soggetti naïve al trattamento con un inibitore del TNFα. 3.Il miglioramento(variazione)rispetto al basale a 24 sett. con secukinumab è superiore al placebo per il danno strutturale articolare/osseo nel sottogruppo di soggetti naïve al trattamento con un inibitore del TNFα. 4.Il trattamento per 12 mesi con secukinumab è superiore al trattamento ritardato con placebo di secukinumab/ secukinumab,relativamente alla proporzione di soggetti che raggiungono una risposta clinica maggiore nel sottogruppo di soggetti naïve al trattamento con un inibitore del TNFα |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or non-pregnant, non-lactating female subjects at least 18 years of age 2. Diagnosis of PsA classified by CASPAR criteria (see Appendix 2) and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of 78 and ≥3 swollen joints out of 76 (dactylitis of a digit counts as one joint each) 3. RF and anti-CCP antibodies negative. 4. Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥2 cm diameter (but not in intertriginous areas such as armpits, or chest between breasts, or groin) or nail changes consistent with psoriasis or a documented history of plaque psoriasis. SEE PROTOCOL FOR MORE DETAILS |
1. Uomini o donne, non in gravidanza o in allattamento, di età maggiore o uguale a 18 anni 2. Diagnosi di PsA classificata secondo i criteri CASPAR con sintomi da almeno 6 mesi di PsA da moderata a severa, con presenza al Basale di almeno 3 articolazioni doloranti su 78 e di almeno 3 articolazioni gonfie su 76 (la dattilite di un dito conta come una articolazione) 3. Fattore reumatoide e anticorpi anti-CCP negativi 4. Diagnosi di psoriasi a placche attiva, con almeno una placca psoriasica di diametro ≥2 cm (ma non alle ascelle, o al torace tra i seni o all’inguine) o modifiche delle unghie compatibili con psoriasi o una storia documentata di psoriasi a placche. CONSULTARE IL PROTOCOLLO PER MAGGIORI DETTAGLI |
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E.4 | Principal exclusion criteria |
1. Chest X-ray with evidence of ongoing infectious or malignant process, obtained within 3 months of screening and evaluated by a qualified physician. 2. Subjects who have previously been treated with more than 3 different TNFα inhibitors (investigational or approved). 3 Subjects taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine). 4 Subjects who have ever received biologic immunomodulating agents except for those targeting TNFα, investigational or approved. 5 Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor. 6 Previous treatment with any cell-depleting therapies including but not limited to anti-CD20 and investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19) |
1. Radiografia al torace con evidenza di processi infettivi o neoplasie in atto, effettuata nei 3 mesi prima dello screening e valutata da un medico qualificato 2. Pazienti precedentemente trattati con più di 3 differenti farmaci diretti contro il TNFα (in corso di sviluppo o già approvati) 3. Soggetti che assumono analgesici oppiacei ad alta potenza (ad es. metadone, idromorfone o morfina) 4. Soggetti che hanno già ricevuto farmaci biologici immunomodulatori, con l’eccezione di quelli diretti verso il TNFα, in sviluppo o già approvati. 5. Precedente esposizione a secukinumab o a qualsiasi altro farmaco biologico diretto verso l’IL-17 o il recettore dell’L-17 6. Qualsiasi precedente terapia in grado di determinare deplezione cellulare, inclusi ma non limitati a anti-CD20, farmaci in sviluppo (ad es. CAMPATH, anti-CD4, anti-CD5, anti-CD3, e anti-CD19) |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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) |
- HAQ-DI, and van der Heijde modified total Sharp Score - Major clinical response |
- HAQ-DI, e punteggio totale Sharp modificato secondo van der Heijde - Maggiore risposta clinica |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Respectively: - 16 weeks - 52 weeks |
Rispettivamente: - 16 settimane - 52 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 | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 54 |
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 |
Argentina |
Australia |
Brazil |
Canada |
Israel |
Peru |
Philippines |
Russian Federation |
Singapore |
Thailand |
Turkey |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 33 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |