E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Axial Psoriatic Arthritis |
Artritis Psoriásica Axial |
|
E.1.1.1 | Medical condition in easily understood language |
Axial Psoriatic Arthritis |
Artritis Psoriásica Axial |
|
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 | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
|
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 secukinumab 300 mg s.c. is superior to placebo in the achievement of ASAS 20 response at Week 12. |
Demostrar que secukinumab 300 mg s.c. es superior al placebo en alcanzar una respuesta ASAS 20 en la Semana 12. |
|
E.2.2 | Secondary objectives of the trial |
To demonstrate that secukinumab 150 mg s.c. is superior to placebo in the achievement of ASAS 20 response at Week 12 after superiority of 300 mg is established.
To evaluate secukinumab 300 mg and 150 mg s.c. versus placebo at Week 12
- in the achievement of ASAS 40. - in the achievement of Bath ankylosing spondylitis disease activity index (BASDAI) 50. - in the reduction of spinal pain measured by visual analog scale (VAS). - in achieving an improvement in Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index. - in achieving an improvement in health assessment questionnaire disability index (HAQ-DI©). - in achieving an improvement in the functional assessment of chronic illness therapy fatigue scale (FACIT Fatigue©). - in achieving an improvement in the ASAS health index. - based on the proportion of patients achieving an American College of Rheumatology (ACR) 20 response.
To evaluate the safety and tolerability of secukinumab. |
Demostrar que secukinumab 150mg s.c. es superior al placebo en alcanzar una respuesta ASAS 20 en la Semana 12 después de establecerse la superioridad de 300mg.
Evaluar secukinumab 300mg y 150mg s.c. frente a placebo en la Semana 12
-en alcanzar una respuesta ASAS 40. -en alcanzar un índice de actividad de Bath para espondilitis anquilosante 50. -en reducir el dolor de columna medido con escala visual analógica. -en alcanzar una mejoría en el índice de entesitis del Consorcio de Investigación de la Espondiloartritis de Canadá. -en alcanzar una mejoría en el índice de discapacidad del cuestionario de evaluación de la salud(HAQ-DI©). -en alcanzar una mejoría en la evaluación funcional del tratamiento de las enfermedades crónicas – Escala de fatiga (FACIT-Fatigue©). -en alcanzar una mejoría en el índice de salud ASAS. -en base a la proporción de pacientes que alcancen una respuesta 20 del Colegio Americano de Reumatología.
Evaluar la seguridad y tolerabilidad de secukinumab |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Written informed consent must be obtained before any assessment is performed. - Diagnosis of psoriatic arthritis classified by Classification criteria for psoriatic arthritis (CASPAR) criteria. - Active spinal disease defined by Bath ankylosing spondylitis disease activity index (BASDAI) score ≥ 4. - Spinal Pain visual analog scale (VAS) ≥ 40 (on a VAS 100 scale). - Inadequate Response to at least 2 nonsteroidal anti-inflammatory drugs over a 4 weeks period.
Other protocol-defined inclusion criteria may apply. |
- Se debe obtener consentimiento informado por escrito antes de que se realice ninguna de las evaluaciones. - Diagnóstico de APs clasificada según los criterios CASPAR. - Enfermedad activa de la columna vertebral definida mediante la puntuación BASDAI >/= 4. - Dolor de columna medido mediante EVA >/= 40 en la visita basal (en una escala EVA 100). - Respuesta inadecuada a al menos 2 AINEs durante un período de 4 semanas.
Otros criterios de inclusión definidos en el protocolo pueden aplicar. |
|
E.4 | Principal exclusion criteria |
- History of exposure to other IL-17 or IL-23 inhibitor biologic drug. - History of exposure to previous biologic disease modifying anti-rheumatic drugs (DMARDs) (Tumor necrosis factor (TNF) blockers or Ustekinumab). - Current treatment with disease modifying anti-rheumatic drugs (DMARDs) other than Methotrexate. - Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine). - Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician.
Other protocol-defined exclusion criteria may apply. |
- Antecedentes de exposición a otro(s) fármaco(s) biológico(s) inhibidor(es) de IL-17 o IL-23. - Antecedentes de exposición a fármaco(s) antirreumático(s) modificador(es) de la enfermedad (FAME(s)) biológico(s) (bloqueadores del factor de necrosis tumoral (TNF) o ustekinumab). - Tratamiento actual con FAME(s) distintos a MTX. - Pacientes que tomen analgésicos opioides de alta potencia (p. ej., metadona, hidromorfona, morfina). - Radiografía de tórax o RM de tórax con evidencia de proceso infeccioso o maligno en curso, obtenida en los 3 meses previos a la Selección y evaluada por un médico cualificado.
Otros criterios de exclusión definidos en el protocolo pueden aplicar. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Assessment of spondyloarthritis international society (ASAS) 20 response |
Evaluación respuesta según la Sociedad Internacional para la evaluación de la espondiloartritis (ASAS) 20 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At Week 12 |
En la semana 12 |
|
E.5.2 | Secondary end point(s) |
- Assessment of spondyloarthritis international society (ASAS) 20 response. (a) - Assessment of spondyloarthritis international society (ASAS) 40 response. (a) - Bath ankylosing spondylitis disease activity index (BASDAI) 50 response. (a) - Spinal pain visual analog scale (VAS) scale. (b) - Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index. (b) - Health assessment questionnaire – disability index (HAQ-DI). (b) - Functional assessment of chronic illness therapy fatigue scale (FACIT-Fatigue). (b) - Assessment of spondyloarthritis international society (ASAS) Health Index. (b) - American College of Rheumatology (ACR) 20 response. (a) - Percentage of patients with Adverse Events. (a) |
- Evaluación de respuesta según la Sociedad Internacional para la evaluación de la espondiloartritis (ASAS) 20. (a) - Evaluación de respuesta según la Sociedad Internacional para la evaluación de la espondiloartritis (ASAS) 40. (a) - Índice de actividad de Bath para la espondilitis anquilosante (BASDAI) 50.(a) - Dolor de columna según escala visual analógica (EVA). (b) - Índice de entesitis del Consorcio de Investigación de la Espondiloartritis de Canadá (SPARCC).(b) - Cuestionario de evaluación de la salud – Índice de discapacidad (HAQ-DI©).(b) - Evaluación funcional del tratamiento de las enfermedades crónicas – Escala de fatiga (FACIT-Fatigue©). (b) - Índice de salud ASAS.(b) - Colegio Americano de Reumatología (ACR) respuesta 20. (a) - Porcentaje de pacientes con Acontecimientos Adversos.(a) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
a) at week 12 b) at baseline, at week 12 |
a) en la semana 12 b) en la visita basal, en la semana 12 |
|
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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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 | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 99 |
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 |
Belgium |
Bulgaria |
Czech Republic |
Denmark |
Estonia |
Finland |
France |
Germany |
Greece |
Hungary |
Ireland |
Israel |
Italy |
Norway |
Poland |
Romania |
Russian Federation |
Spain |
Sweden |
Switzerland |
United Kingdom |
|
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 Último Paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 8 |