E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
non-radiographic axial spondyloarthritis |
espondiloartritis axial no radiográfica. |
|
E.1.1.1 | Medical condition in easily understood language |
non-radiographic axial spondyloarthritis |
espondiloartritis axial no radiográfica. |
|
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 | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10076297 |
E.1.2 | Term | Non-radiographic axial spondyloarthritis |
E.1.2 | System Organ Class | 100000004859 |
|
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 superiority of secukinumab 150 mg s.c., with or without loading, over placebo at Week 16, based on the proportion of patients achieving an ASAS40 response (Assessment of SpondyloArthritis International Society criteria). |
Demostrar la superioridad de secukinumab 150 mg s.c. con o sin dosis de carga respecto a placebo en la semana 16, basándose en la proporción de pacientes que alcanzan una respuesta ASAS40 (criterios de Assessment of SpondyloArthritis International Society). |
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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 patients meeting the ASAS 5/6 response criteria - the change from baseline in total Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) - the proportion of patients achieving BASDAI 50 - the change from baseline of high sensitivity C-Reactive Protein (hsCRP) - the change from baseline in Short Form-36 Physical Component Summary (SF-36 PCS) - the proportion of subjects achieving an ASAS20 response - the change from baseline in total Bath Ankylosing Spondylitis Functional Index (BASFI) - the change from screening in SI joint edema on MRI - the proportion of patients achieving ASAS partial remission - Overall safety and tolerability of secukinumab |
Demostrar que la eficacia de secukinumab 150 mg s.c. con o sin dosis de carga en la semana 16 es superior a la de placebo basándose en: - la proporción de pacientes que cumplen los criterios de respuesta ASAS 5/6. - el cambio respecto a la basal del índice de actividad de la enfermedad espondilitis anquilosante de Bath (BASDAI). - la proporción de pacientes que alcanzan una BASDAI 50. - el cambio respecto a la basal de la proteína C reactiva ultrasensible (PCRus). - el cambio respecto a la basal del resumen del componente físico del cuestionario de salud SF-36 (RCF del SF-36). - la proporción de sujetos que alcanzan una respuesta ASAS20. - el cambio respecto a la basal del índice funcional de espondilitis anquilosante de Bath (BASFI). - el cambio respecto a la selección en el edema en articulación SI en la RM. - la proporción de pacientes que alcanzan una remisión parcial ASAS. - Seguridad y tolerabilidad globales de secukinumab. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or non-pregnant, non-nursing female patients at least 18 years of age - Diagnosis of axSpA according to ASAS axSpA criteria - Objective signs of inflammation (MRI or abnormal CRP) - Active axSpA as assessed by total BASDAI >/=4 cm - Spinal pain as measured by BASDAI question n.2 >/= 4 cm (0-10 cm) at baseline - Total back pain as measured by VAS >/= 40 mm (0-100 mm) at baseline - Patients should have been on at least 2 different NSAIDs with an inadequate response - Patients who have been on a TNF alpha inhibitor (not more than one) must have experienced an inadequate response - Other protocol-defined inclusion criteria may apply |
- Pacientes varones o mujeres que no estén embarazadas ni en periodo de lactancia de al menos 18 años de edad. - Diagnóstico de EsAax según los criterios ASAS para EsAax. - Signos objetivos de inflamación (RM o anormal PCR). - EsAax activa evaluada mediante un BASDAI total >/= 4 cm - Dolor en la columna vertebral medido mediante la pregunta n.º 2 del BASDAI >/= 4 cm (0-10 cm) en la basal. - Dolor de espalda total medido mediante EVA >/= 40 mm (0-100 mm) en la basal. - Los pacientes deben haber tomado al menos dos AINEs con una respuesta inadecuada. - Los pacientes que hayan estado tomando un inhibidor del TNF alpha (no más de uno) deben haber presentado una respuesta inadecuada. - Se pueden aplicar otros criterios de inclusión definidos en el protocolo. |
|
E.4 | Principal exclusion criteria |
- Patients with radiographic evidence for sacroiliitis, grade >/= 2 bilaterally or grade >/= 3 unilaterally - Inability or unwillingness to undergo MRI - Chest X-ray or MRI with evidence of ongoing infectious or malignant process - Patients taking high potency opioid analgesics - Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor - Pregnant or nursing (lactating) women - Other protocol-defined exclusion criteria may apply |
- Pacientes con signos radiográficos de sacroileítis de grado >/= 2 bilateral o grado >/= 3 unilateral. - Incapacidad o rechazo a someterse a una RM. - Radiografía de tórax o RM con pruebas de proceso infeccioso o maligno en curso. - Pacientes que tomen analgésicos opioides de alta potencia. - Exposición previa a secukinumab o a cualquier otro fármaco biológico directamente dirigido contra IL-17A o el receptor de IL-17. - Mujeres embarazadas o en periodo de lactancia. - - Se pueden aplicar otros criterios de exclusión definidos en el protocolo. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of participants who achieved an ASAS 40 response (Assessment of SpondyloArthritis International Society criteria) |
la proporción de pacientes que alcanzan una respuesta ASAS40 (criterios de Assessment of SpondyloArthritis International Society). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- The proportion of participants who achieved an ASAS 5/6 (a) - Change in BASDAI over time (a) - The proportion of patients to achieve a BASDAI 50 response (a) - Change in hsCRP over time (a) - Change in SF-36 physical Component Summary over time (a) - The proportion of participants who achieved an ASAS 20 response (a) - Change in BASFI over time (a) - Change in SI Joint Edema (a) - The proportion of patients who achieved an ASAS partial remission (a) - Safety and tolerability (b) |
- La proporción de pacientes que cumplen los criterios de respuesta ASAS 5/6 (a). - El cambio respecto a la basal del índice de actividad de la enfermedad espondilitis anquilosante de Bath (BASDAI) (a). - La proporción de pacientes que alcanzan una BASDAI 50 (a). - El cambio respecto a la basal de la proteína C reactiva ultrasensible (PCRus) (a). - El cambio respecto a la basal del resumen del componente físico del cuestionario de salud SF-36 (RCF del SF-36) (a). - La proporción de sujetos que alcanzan una respuesta ASAS20 (a). - El cambio respecto a la basal del índice funcional de espondilitis anquilosante de Bath (BASFI) (a). - El cambio respecto a la selección en el edema en articulación SI en la RM (a). - La proporción de pacientes que alcanzan una remisión parcial ASAS (a). - Seguridad y tolerabilidad (b). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
(a) Week 16 (b) Week 112 |
(a) Semana 16 (b) Semana 112 |
|
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 | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Serum biomarkers |
Biomarcadores séricos |
|
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 | 18 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 105 |
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 |
Belgium |
Bulgaria |
Czech Republic |
France |
Germany |
Hungary |
Israel |
Italy |
Japan |
Netherlands |
Norway |
Poland |
Portugal |
Russian Federation |
Spain |
Sweden |
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 |
Última visita del último 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 | 5 |
E.8.9.1 | In the Member State concerned days | 13 |
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 | 6 |