E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ankylosing Spondylitis |
espondilitis anquilosante |
|
E.1.1.1 | Medical condition in easily understood language |
Bechterev syndrom, Marie-Strümpell disease |
Enfermedad de Marie?Strümpell o Enfermedad de Bechterew |
|
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 | 17.1 |
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 secukinumab 150 mg at Week 16 with or without a loading regimen is superior to placebo based on the proportion of subjects achieving an ASAS20 (Assessment of SpondyloArthritis International Society criteria) response. |
Demostrar que la eficacia de secukinumab 150 mg, con o sin dosis de carga, en la semana 16 es superior a placebo basándose en la proporción de sujetos que alcanzan una respuesta ASAS20 (los criterios de Assessment of SpondyloArthritis International Society). |
|
E.2.2 | Secondary objectives of the trial |
-To demonstrate that the efficacy of secukinumab 150 mg s.c., with or without loading, at Week 16 is superior to placebo based on ?the proportion of subjects achieving an ASAS40 response ?the change from baseline of high sensitivity C-Reactive Protein (hsCRP) ?the proportion of patients meeting the ASAS 5/6 response criteria ?the change from baseline in total Bath Ankylosing Spondylitis Disease Activity (BASDAI) ?the change from baseline in Short Form-36 Physical Component Summary (SF-36 PCS) ?the change from baseline in Ankylosing Spondylitis Quality of Life (ASQoL) -To demonstrate that the efficacy of secukinumab 150 mg s.c., with or without loading, at Week 4 is superior to placebo based on: ?the proportion of subjects achieving an ASAS20 response ?the proportion of subjects achieving an ASAS40 response - Overall safety and tolerability of secukinumab |
1. Demostrar que la eficacia de secukinumab 150 mg s.c., con o sin dosis de carga, en la semana 16 es superior a placebo basándose -en la proporción de sujetos que alcanzan una respuesta ASAS40. -en el cambio respecto a la basal de la proteína C reactiva ultrasensible (PCRus). - en la proporción de pacientes que cumplen los criterios de respuesta ASAS 5/6. - en el cambio respecto a la basal del índice de actividad de la enfermedad espondilitis anquilosante de Bath (BASDAI). - en el cambio respecto a la basal del resumen del componente físico (RCF) del SF-36 (RCF del SF-36). - en el cambio respecto a la basal de la calidad de vida de la espondilitis anquilosante (CVEA). - en la proporción de sujetos que alcanzan una respuesta ASAS20. - en la proporción de sujetos que alcanzan una respuesta ASAS40. -Seguridad y tolerabilidad globales de secukinumab. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Moderate to severe AS - Prior radiographic evidence according to the Modified NY Criteria (1984) - Inadequate response to NSAIDs Other protocol-definied inclusion criteria may apply. |
Diagnósticos de EA de moderada a grave con pruebas radiológicas documentadas previas (radiografía o informe del radiólogo) que cumplan los criterios de Nueva York modificados para EA. Los pacientes deben haber tomado AINE en la dosis máxima recomendada durante al menos 3 meses con una respuesta inadecuada o durante menos de 3 meses, si se han retirado por intolerancia, toxicidad o contraindicaciones. Otros criterios de inclusión también aplican (revisar protocolo) |
|
E.4 | Principal exclusion criteria |
- Pregnancy or lactation - On-going infectious or malignant process on a chest X-ray or MRI - Previous exposure to IL-17 or IL-17R targeting therapies - Previous exposure to any biological immunomodulating agent excluding TNF antagonists - Previous cell depleting therapy Other protocol-definied exclusion criteria may apply. |
Mujeres embarazadas o en periodo de lactancia Radiografía de tórax o resonancia magnética (RM) que muestre proceso infeccioso o maligno en curso. Exposición previa a secukinumab o a cualquier otro fármaco biológico directamente dirigido contra IL-17A o el receptor de IL-17. Pacientes que hayan sido tratados previamente con cualquier fármaco inmunomodulador biológico salvo aquellos que actúan contra TNF?. Pacientes que estén tomando más de un fármaco anti-TNF?. Tratamiento previo con cualquier terapia de reducción celular. Otros criterios de exclusión también aplican (ver protocolo) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Assessment of Spondyloarthritis International Society criteria, ASAS 20 |
Criterios de Assessment of SpondyloArthritis International Society (ASAS 20). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- ASAS 40 response (a) - Serum hsCRP (a) - ASAS 5/6 response (a) - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (a) - Short Form-36 Physical Compenent Summary (SF-36 PCS) health survey (a) - Ankylosing Spondylitis Quality of Life (ASQoL) (a) - Overall safety and tolerability (b) |
- Cambio respecto a la basal en la PCRus, (a) - Respuesta ASAS 5/6, (a) - Cambio respecto a la basal en la BASDAI total, (a) - Cambio respecto a la basal en RCF del SF-36, (a) - Cambio respecto a la basal en la CVEA, (a)
- Seguridad y tolerabilidad (b) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
(a) 16 weeks (b) 112 weeks |
(a) 16 semanas (b) 112 semanas |
|
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 | No |
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 | Yes |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 77 |
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 |
Austria |
Bulgaria |
Canada |
Czech Republic |
Denmark |
Finland |
Germany |
Greece |
Italy |
Mexico |
Netherlands |
Norway |
Poland |
Russian Federation |
Slovakia |
Spain |
Switzerland |
United Kingdom |
United States |
|
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
|
LVLS |
Ultima visita ultimo paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
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 | 1 |