E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ankylosing spondylitis |
Spondilite anchilosante |
|
E.1.1.1 | Medical condition in easily understood language |
Bechterev syndrome, Marie-Strümpell disease |
Sindrome di Bechterev, malattia di Marie-Strümpell |
|
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 | PT |
E.1.2 | Classification code | 10002556 |
E.1.2 | Term | Ankylosing spondylitis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
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 that the efficacy of each secukinumab regimen at Week 16 is superior to placebo in patients with active Ankylosing Spondylitis based on the proportion of patients achieving an ASAS 20 (Assessment of Spondyloarthritis International Society criteria) response in the subgroup of patients who are TNFα inhibitor naïve |
Dimostrare che l’efficacia di ciascun regime di secukinumab a 16 settimane è superiore al placebo in pazienti con AS attiva basata sulla proporzione di pazienti che raggiungono la risposta ASAS 20 (criteri di valutazione da parte della Società Internazionale sulla Spondiloartrite) nel sottogruppo di pazienti che non hanno mai ricevuto un trattamento con inibitori del TNFα. |
|
E.2.2 | Secondary objectives of the trial |
1. To demonstrate the efficacy of each secukinumab regimen at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 20 response in the whole study population. 2. To demonstrate the efficacy of each secukinumab regimen at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 40 response in patients who are TNFα inhibitor naïve. 3. To demonstrate the efficacy of each secukinumab regimen at Week 16 is superior to placebo in patients with active AS based on the proportion of patients achieving an ASAS 40 response in the whole study population. |
1. Dimostrare che l’efficacia di ciascun regime di secukinumab a 16 settimane è superiore al placebo in pazienti con AS attiva basata sulla proporzione di pazienti che raggiungono la risposta ASAS 20 nell’intera popolazione in studio; 2. dimostrare che l’efficacia di ciascun regime di secukinumab a 16 settimane è superiore al placebo in pazienti con AS attiva basata sulla proporzione di pazienti che raggiungono la risposta ASAS 40 nei pazienti che non hanno mai ricevuto un trattamento con inibitori del TNFα. 3. Dimostrare che l’efficacia di ciascun regime di secukinumab a 16 settimane è superiore al placebo in pazienti con AS attiva basata sulla proporzione di pazienti che raggiungono la risposta ASAS 40 nell’intera popolazione in studio; Per maggiori dettagli consultare il capitolo 2 del protocollo originale. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Male or non-pregnant, non-lactating female patients at least 18 years of age; • Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984); • Patients should have been on NSAIDs with an inadequate response; • Patients who are regularly taking NSAIDs as part of their AS therapy are required to be on a stable dose; • Patients who have been on an anti-TNFα agent (not more than one) must have experienced an inadequate response. Other protocol-defined inclusion criteria may apply. |
• Uomini o donne, non in gravidanza o in allattamento, di età maggiore o uguale a 18 anni; • Diagnosi di AS da moderata a severa, con documentata precedente evidenza radiologica, in grado di soddisfare i criteri di New York modificati per la AS (1984); • I pazienti devono essere stati trattati con FANS con risposta inadeguata; • I pazienti che stanno assumendo regolarmente FANS come parte della loro terapia per la AS, dovranno assumerli in dose stabile; • I pazienti che sono stati in terapia con un farmaco anti-TNFα (non più di uno) devono avere evidenziato una risposta inadeguata. Per maggiori dettagli consultare il paragrafo 4.1 del protocollo originale. |
|
E.4 | Principal exclusion criteria |
• Chest X-ray with evidence of ongoing infectious or malignant process; • Patients with total ankylosis of the spine; • Patients previously treated with any biological immunomodulating agents except for those targeting TNFα; • Previous treatment with any cell-depleting therapies. Other protocol-defined exclusion criteria may apply. |
• Radiografia al torace con evidenza di processi infettivi o neoplasie in atto; • Pazienti con anchilosi totale della colonna vertebrale; • Pazienti precedentemente trattati con qualsiasi altro farmaco immunomodulante con l’eccezione di farmaci diretti contro il TNFα; • Qualsiasi precedente terapia in grado di determinare deplezione cellulare. Per maggiori dettagli consultare il paragrafo 4.2 del protocollo originale. |
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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) |
ASAS 20 and ASAS 40 |
ASAS 20 e ASAS 40 |
|
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 | 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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 46 |
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 |
Canada |
Mexico |
Peru |
Russian Federation |
Taiwan |
Turkey |
|
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 | 0 |
E.8.9.1 | In the Member State concerned months | 32 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 36 |
E.8.9.2 | In all countries concerned by the trial days | 0 |