E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriatic Arthritis |
Artritis Psoriásica |
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E.1.1.1 | Medical condition in easily understood language |
Psoriatic Arthritis |
Artritis Psoriásica |
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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 | 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 |
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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 monotherapy (300 mg s.c.) at Week 52 is superior to adalimumab monotherapy (40 mg s.c.) based on the proportion of subjects achieving an American College of Rheumatology 20 (ACR20) response. |
Demostrar que la eficacia de secukinumab 300 mg s.c. en monoterapia en la semana 52 es superior a la de adalimumab (40 mg s.c.) en monoterapia basándose en la proporción de sujetos que alcanzan una respuesta ACR20 del American College of Rheumatology. |
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E.2.2 | Secondary objectives of the trial |
To demonstrate that: Secukinumab monotherapy (300 mg s.c.) is superior to adalimumab monotherapy (40 mg s.c.) at Week 52, based on the proportion of subjects achieving - PASI90 response. - ACR50 response.
The improvement (change) from baseline on secukinumab monotherapy (300 mg s.c.) is superior to adalimumab monotherapy (40 mg s.c.) at Week 52, for the Health Assessment Questionnaire – Disability Index (HAQ-DI©) score.
Secukinumab monotherapy (300 mg s.c.) is superior to adalimumab monotherapy (40 mg s.c.) at Week 52, based on the proportion of subjects achieving the resolution of enthesitis.
An additional secondary objective is to evaluate the safety and tolerability of secukinumab monotherapy (300 mg s.c.) compared with adalimumab monotherapy (40 mg s.c.) as assessed by vital signs, clinical laboratory values, and adverse events monitoring. |
Demostrar que: 1. Secukinumab en monoterapia (300 mg s.c.) es superior a adalimumab en monoterapia (40 mg s.c.) en la semana 52, basándose en la proporción de sujetos que alcanzan - Respuesta PASI90. - Respuesta ACR50 response.
La mejora (cambio) respecto a la basal en secukinumab en monoterapia (300 mg s.c.) es superior a adalimumab en monoterapia (40 mg s.c.) en la semana 52, basándose en el índice de discapacidad del cuestionario de evaluación de la salud (HAQ-DI©).
Otro objetivo secundario es evaluar la seguridad y tolerabilidad de secukinumab en monoterapia (300 mg s.c.) en comparación con adalimumab en monoterapia (40 mg s.c.) evaluadas según las constantes vitales, los valores de laboratorio clínico y la monitorización de acontecimientos adversos |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Diagnosis of PsA classified by CASPAR; Rheumatoid factor and anti-CCP antibodies negative; diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥2cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis; inadequate control of symptoms with NSAIDs; inadequate control of symptoms with a conventional DMARD.
Other protocol-defined inclusion criteria may apply. |
Diagnóstico de APs según los criterios de clasificación CASPAR; Factor reumatoide (FR) y anticuerpos anti-péptido cíclico citrulinado (CCP) negativos, diagnóstico de psoriasis en placas activa con al menos una placa psoriásica, con un diámetro de ≥2 cm o cambios en las uñas que indiquen psoriasis o antecedentes documentados de psoriasis en placas, sujetos con un control inadecuado de los síntomas con AINEs, sujetos con un control inadecuado de los síntomas con FAME convencional.
Se pueden aplicar otros criterios de inclusión definidos en el protocolo. |
|
E.4 | Principal exclusion criteria |
- Pregnant or nursing women, evidence of ongoing infectious or malignant process; previous exposure to any biologic drug for Psoriatic Arthritis or Psoriasis; subjects taking high potency opioid analgesics; ongoing use of prohibited psoriasis treatments / medications; previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents
Other protocol-defined exclusion criteria may apply. |
Mujeres embarazadas o en periodo de lactancia, evidencia de proceso infeccioso o maligno, exposición previa a cualquier fármaco biológico para artritis psoriásica o psoriasis, sujetos que reciban analgésicos opioides de alta potencia, uso actual de tratamientos/medicaciones prohibidas para la psoriasis, Tratamiento previo con terapias de depleción celular, incluyendo, entre otros, anti-CD20 o fármacos en investigación. Se pueden aplicar otros criterios de inclusión definidos 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 |
Respuesta ACR20 del American College of Rheumatology. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- PASI90 (a) - ACR50 response (a) - Health Assessment Questionnaire - Disability Index (HAQDI score), relative to baseline (a) - Resolution of enthesitis (a) |
- PASI90 (a) - Respuesta ACR50 (a) - Indice de discapacidad del cuestionario de evaluación de la salud (HAQ-DI©) (a) - Resolución de la entesitis. (a) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
a) at 52 weeks |
a) A las 52 semanas |
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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 | No |
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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 26 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 149 |
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 |
Czech Republic |
Denmark |
Estonia |
Finland |
France |
Germany |
Greece |
Hungary |
Iceland |
India |
Ireland |
Israel |
Italy |
Korea, Republic of |
Latvia |
Lithuania |
Netherlands |
Poland |
Portugal |
Russian Federation |
Slovakia |
Spain |
Sweden |
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 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
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 | 4 |