E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriatic Arthritis |
Artritis Psoriasica |
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E.1.1.1 | Medical condition in easily understood language |
Psoriatic Arthritis |
Artritis 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 | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
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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 that the efficacy of secukinumab 150 mg s.c. or 300 mg s.c., at Week 24 is superior to placebo based on proportion of subjects achieving American College of Rheumatology 20 (ACR20) response in subjects with active PsA |
Demostrar que la eficacia de secukinumab 150 mg s.c. o 300 mg s.c., en la Semana 24 es superior al placebo en base a la proporción de pacientes que alcancen una respuesta de 20 (ACR20) según la American College of Rheumatology en pacientes con APs activa. |
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E.2.2 | Secondary objectives of the trial |
To demonstrate: - the efficacy of secukinumab 150mg or 300mg at Week 24 is superior to placebo based on the proportion of subjects achieving PASI75 response. - the efficacy of secukinumab 150mg or 300mg at Week 24 is superior to placebo based on the proportion of subjects achieving PASI90 response. - the improvement on secukinumab 150mg or 300mg at Week 24 is superior to placebo for DAS28-CRP (utilizing hsCRP) relative to baseline. - the improvement (change) from baseline on secukinumab 150mg or 300mg is superior to placebo at Week 24 for the physical function assessed by SF-36-PCS. - the improvement (change) from baseline on secukinumab 150mg or 300mg is superior to placebo at Week 24 for the Health Assessment Questionnaire - Disability Index (HAQ-DI score). - the efficacy of secukinumab 150mg or 300mg at Week 24 is superior to placebo based on the proportion of subjects achieving an ACR50 response. - Overall safety and tolerability of secukinumab. |
Demostrar que: La eficacia de secukinumab 150 mg o 300 mg en la Semana 24 es superior a placebo en base a la proporción de pacientes que alcancen un PASI75. La eficacia de secukinumab 150 mg o 300 mg en la Semana 24 es superior a placebo en base a la proporción de pacientes que alcancen un PASI90. La mejoría con secukinumab 150 mg o 300 mg en la Semana 24 es superior a placebo en cuanto a la actividad de la enfermedad evaluada por los cambios en la puntuación DAS28-PCR (utilizando hsPCR) respecto a la visita basal. La mejoría (cambio) desde la visita basal con secukinumab 150 mg o 300 mg es superior al placebo en la Semana 24 para la función física evaluada mediante la encuesta SF-36-PCS. La mejoría (cambio) desde la visita basal con secukinumab 150 mg o 300 mg es superior al placebo en la Semana 24 según puntuación HAQ-DI. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Diagnosis of Psoriatic Arthritis (PsA) classified by ClASification crietria for Psoriatic ARthritis (CASPAR) criteria - Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative - Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis - Inadequate control of symptoms with NSAID Other protocol-definied inclusion criteria may apply |
- Diagnóstico de APs clasificada según los criterios CASPAR y con síntomas durante al menos 6 meses con APs de moderada a grave - Factor reumatoide y anticuerpos anti-CCP negativos en la selección - Diagnóstico de psoriasis en placas activa o cambios en las uñas que coincidan con la psoriasis - Inadecuado control de los sintomas con AINES. Ver otros criterios de inclusion en el protocolo |
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E.4 | Principal exclusion criteria |
- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing infectious or malignant process. - Subjects taking high potency opioid analgesics - Previous exposure to secukinumab or other biologic drug directly targeting interleukin-17 (IL-17) or IL-17 receptor. - Ongoing use of prohibited psoriasis treatments/medications - Subjects who have ever received biologic immunomodulating agents except for those targeting TNF-alpha. - Previous treatment with any cell-depleting therapies Other protocol-definied exclusion criteria may apply |
- Radiografía de tórax o RM de tórax con evidencia de proceso infeccioso o maligno en curso - Pacientes que tomen analgésicos opioides de alta potencia - Exposición previa a secukinumab o a otro fármaco biológico que se dirija directamente a la IL-17 o al receptor de IL-17. - Uso actual de tratamientos / medicaciones prohibidas para el tratamiento de la psoriasis - Pacientes que alguna vez hayan recibido inmunomoduladores biológicos, excepto los que se dirijan al TNF?, en investigación o aprobados - Tratamiento previo con cualquier terapia de depleción celular Ver otros criterios de exclusion en el protocolo |
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E.5 End points |
E.5.1 | Primary end point(s) |
American College of Rheumatology 20 (ACR20) response in subjects treated with secukinumab versus placebo |
Respuesta según la American College of Rheumatology 20 (ACR 20) en pacientes tratados con secukinumab versus placebo |
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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) |
(1) Psoriatic Area and Severity Index 75 (PASI75) response in subjects treated with secukinumab versus placebo (2) Psoriatic Area and Severity Index 90 (PASI90) response in subjects treated with secukinumab versus placebo (3) Disease Activity Score for 28 joints (DAS28-CRP) (utilizing hsCRP) relative to baseline, assessed in subjects treated with secukinumab versus placebo (4) Physical function component of the short-form health survey (SF-36-PCS), relative to baseline, in subjects treated with secukinumab versus placebo (5)Health Assessment Questionnaire - Disability Index (HAQ-DI score), relative to baseline, in subjects treated with secukinumab versus placebo (6) American College of Rheumatology 50 (ACR50) response in subjects treated with secukinumab versus placebo (7) Treatment emergent adverse events for each treatment group |
1) Índice de severidad y área de la psoriasis 75 (PASI75) en pacientes tratados con secukinumab versus placebo (2) Índice de severidad y área de la psoriasis 90 (PASI90) en pacientes tratados con secukinumab versus placebo (3) puntuación de actividad de la enfermedad para 28 articulaciones(DAS28-CRP) (utilizando hsPCR) respecto a la visita basal, en pacientes tratados con secukinumab versus placebo (4) función física evaluada mediante la encuesta de salud abreviada (SF-36-PCS), respecto a la visita basal, en pacientes tratados con secukinumab versus placebo (5) Cuestionario de evaluación de la salud ? Índice de discapacidad(HAQ-DI score), respecto a la visita basal, en pacientes tratados con secukinumab versus placebo (6) Respuesta según la American College of Rheumatology 50 (ACR50) en pacientes tratados con secukinumab versus placebo (7) tratamiento para los efectos adversos que sucedan en cada grupo de tratamiento |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- 24 weeks (1, 2, 3, 4, 5, 7) - Week 24 (6) |
- 24 semanas (1, 2, 3, 4, 5, 7) - Semana 24 (6) |
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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 | 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 related to targeted pathway |
Biomarcadores sericos relacionados con la via de estudio |
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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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
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 |
Bulgaria |
Canada |
Denmark |
Italy |
Netherlands |
Norway |
Portugal |
Sweden |
Australia |
Brazil |
Czech Republic |
Finland |
Germany |
Hungary |
Iceland |
Malaysia |
Spain |
Russian Federation |
Switzerland |
United Kingdom |
United States |
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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
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LVLS |
Ultima visita del ultimo paciente |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 10 |
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 | 11 |