E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis |
Artritis juvenil psoriásica y artritis relacionada con entesitis |
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E.1.1.1 | Medical condition in easily understood language |
Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis |
Artritis juvenil psoriásica y artritis relacionada con entesitis |
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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 | 10072745 |
E.1.2 | Term | Enthesitis related arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10076674 |
E.1.2 | Term | Juvenile psoriatic arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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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 time to flare in Treatment Period 2 is longer with secukinumab for combined ERA and JPsA groups than with placebo. |
Demostrar que el tiempo hasta el brote en el Período de tratamiento 2 es más largo con secukinumab para los grupos combinados de ERA y APsJ que con placebo |
|
E.2.2 | Secondary objectives of the trial |
1. To evaluate the effect of secukinumab treatment for all patients and each JIA category in Treatment Period 1 up to Week 12 (end of Treatment period 1) with respect to: - JIA ACR (American College of Rheumatology) 30/50/70/90/100 and inactive disease status - Each JIA ACR core component - Change from baseline Juvenile Arthritis Disease Activity Score (JADAS) - Total enthesitis count - Total dactylitis count 2. To evaluate withdrawal effect of secukinumab treatment for all patients and each JIA category during and at the end of Treatment Period 2 with respect to: - JIA ACR 30/50/70/90/100 and inactive disease status 3. To evaluate Pharmacokinetics (PK) of secukinumab and confirm the predicted dose in Treatment Period 1 4. To evaluate the safety/tolerability and immunogenicity of Secukinumab |
1. Evaluar el efecto del tratamiento con secukinumab en todos los pacientes en cada categoría de AIJ en el Período de tratamiento 1 hasta la Semana 12 (final del Período de tratamiento 1) con respecto a: - AIJ ACR (American College of Rheumatology) 30/50/70/90/100 y estado de enfermedad inactiva - Componentes que conforman el AIJ ACR - Cambio respecto al valor basal en la Puntuación de actividad de la enfermedad para la artritis juvenil (JADAS) - Número total con entesitis - Número total con dactilitis
2. Evaluar el efecto de la retirada del tratamiento con secukinumab en todos los pacientes y cada categoría de AIJ durante y al final del período de tratamiento 2 con respecto a: - AIJ ACR 30/50/70/90/100 y estado de enfermedad inactiva 3. Evaluar la farmacocinética (PK) de secukinumab y confirmar la dosis prevista en el Período de tratamiento 1 4. Evaluar la seguridad/tolerabilidad e inmunogenicidad de secukinumab. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Confirmed diagnosis of Enthesitis-related arthritis (ERA) or Juvenile psoriatic arthritis (JPsA) according to the international League of Associations for Rheumatology (ILAR) classification criteria of at least 6 months duration. 2. Active disease (ERA or JPsA) defined as having both: - at least 3 active joints - at least 1 site of active enthesitis at baseline or documented by history. 3. Inadequate response (at least 1 month) or intolerance to at least 1 nonsteroidal anti-inflammatory drugs (NSAID) 4. Inadequate response (at least 2 months) or intolerance to at least 1 Disease-modifying antirheumatic drugs (DMARD) 5. No concomitant use of second line agents such as disease-modifying and/or immunosuppressive drugs.
Other protocol-defined inclusion/exclusion criteria apply. |
1. Diagnóstico confirmado de ERA según los criterios de clasificación de la ILAR o de APsJ según los criterios de clasificación modificados de la ILAR que deberá haber tenido lugar al menos 6 meses antes de la Selección 2. Enfermedad activa (ERA o APsJ) definida como presentar las 2 condiciones siguientes: ≥ 3 articulaciones activas (tumefactas o si no son tumefactas deberán ser tanto dolorosas como con limitación del movimiento) en la visita basal. ≥1 zona de entesitis activa en la visita basal o documentada en la historia 3. Respuesta inadecuada (≥ 1 mes) o intolerancia a ≥ 1 NSAID (antiinflamatorio no esteroideo) 4. Respuesta inadecuada (≥ 2 meses) o intolerancia a ≥ 1 FAME (fármacos antirreumáticos modificadores de la enfermedad) 5. No se permitirá el uso concomitante de fármacos de segunda línea tales como fármacos modificadores de la enfermedad y/o inmunosupresores.
Aplicaran el resto de criterios de inclusión/exclusión definidos por protocolo. |
|
E.4 | Principal exclusion criteria |
1. Patients fulfilling any ILAR diagnostic JIA category other than ERA or JPsA. 2. Patients who have ever received biologic immunomodulating agents. 3. Patients taking any non-biologic DMARD except for MTX (or sulfasalazine for ERA patients only). 4. Patients with active uncontrolled inflammatory bowel disease or active uncontrolled uveitis.
Other protocol-defined inclusion/exclusion criteria apply. |
1. Pacientes que cumplan cualquier categoría diagnóstica de AIJ según la ILAR distinta a ERA o APsJ. 2. Sujetos que nunca hayan recibido inmunomoduladores biológicos, 3. Sujetos que estén tomando algún FAME no biológico excepto MTX (metotrexato) (o sulfasalazina [SSZ] sólo en pacientes con ERA) 4. Pacientes con enfermedad inflamatoria intestinal activa no controlada o con uveítis activa no controlada
Aplicaran el resto de criterios de inclusión/exclusión definidos por protocolo. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Time to flare in Treatment Period 2 |
Tiempo hasta el brote en el Período de tratamiento 2 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From Week 12 until max Week 104 |
Desde la semana 12 hasta como máximo la semana 104. |
|
E.5.2 | Secondary end point(s) |
Change from baseline for Juvenile idiopathic arthritis (JIA) American college of rheumatology (ACR) 30/50/70/90/100 response and inactive disease status (a)
Change from baseline for each JIA ACR core component (a)
Chance from baseline Juvenile Arthritis Disease Activity Score (JADAS) score (a)
Change from baseline in total enthesitis count (a)
Change from baseline in total dactylitis count (a)
Percentage of participants with JIA ACR 30/50/70/90/100 and inactive disease (b)
Secukinumab serum concentration (c)
Number of participants with reported Adverse Events (c)
Percentage of participants with anti-secukinumab antibodies (c) |
Criterios de respuesta para artritis idiopática juvenil (AIJ) ACR (American College of Rheumatology) 30/50/70/90/100y estado de enfermedad inactive
Cambios desde basal para cada componente que conforman el AIJ ACR
Cambio respecto al valor basal en la Puntuación de actividad de la enfermedad para la artritis juvenil (JADAS)
Cambios desde basal en el número total con entesitis
Cambios desde basal en el número total con dactilitis
Porcentaje de participantes con AIJ ACR 30/50/70/90/100 y estado de enfermedad inactive
Concentración en suero de secukinumab
Número de participantes con Efectos Adversos reportados
Porcentaje de participantes con anticuerpos anti-secukinumab. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
(a) = 12 weeks (b) = From week 12 to up to week 104 (c) = 104 weeks |
(a) = 12 semanas (b) = Desde la semana 12 hasta la semana 104 (c) = 104 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 | 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) | No |
E.8.2.2 | Placebo | Yes |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
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 |
Germany |
Italy |
Netherlands |
Poland |
Russian Federation |
South Africa |
Spain |
Turkey |
United Kingdom |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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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|
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 | 6 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 15 |