E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis |
Artritis relacionada con entesitis y Artritis psoriásica juvenil |
|
E.1.1.1 | Medical condition in easily understood language |
Enthesitis-Related Arthritis and Juvenile Psoriatic Arthritis |
Artritis relacionada con entesitis y Artritis psoriásica juvenil |
|
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 | 20.0 |
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 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
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 |
|
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 evaluate the long-term efficacy of secukinumab (provided as pre-filled syringes) with respect to JIA ACR30 response over time up to Week 308 in patients with active JPsA and ERA subtypes of JIA and who completed the Phase III study CAIN457F2304. |
Evaluar la eficacia a largo plazo de secukinumab administrado por vía subcutánea (en jeringas precargadas) con respecto a la respuesta ACR30 en AIJ hasta la visita de la semana 308 en pacientes con los subtipos APJ y ARE activas de AIJ y que hayan completado el estudio de fase III CAIN457F2304. |
|
E.2.2 | Secondary objectives of the trial |
1. To evaluate the long-term safety, tolerability and immunogenicity of secukinumab as assessed by vital signs, clinical laboratory variables and adverse events monitoring over time up to Week 308. 2. To evaluate the long-term effect of secukinumab treatment for all patients and each JIA category with respect to: -JIA ACR/50/70/90/100 and inactive disease status -Each JIA ACR core component -Change from baseline of core study CAIN457F2304 -Juvenile Arthritis Disease Activity Score (JADAS) -Total Enthesitis count -Total Dactylitis count 3. To evaluate Pharmacokinetics (PK) of secukinumab. |
1. Evaluar la seguridad, tolerabilidad e inmunogenicidad a largo plazo de secukinumab según las constantes vitales, variables clínicas de laboratorio y monitorización de acontecimientos adversos hasta la semana 308. 2. Evaluar el efecto a largo plazo del tratamiento con secukinumab en todos los pacientes y cada categoría de AIJ con respecto a: - ACR/50/70/90/100 en AIJ y estado de enfermedad inactiva; - cada componente principal del ACR en AIJ; - cambio respecto a la basal del estudio principal CAIN457F2304; - Juvenile Arthritis Disease Activity Score (JADAS); - recuento total de entesitis; - recuento total de dactilitis. 3. Evaluar la farmacocinética (PK) de secukinumab |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patient must have participated in core study CAIN457F2304, and must have completed the entire treatment period up to and including Week 104. 2. Patients must be deemed by the investigator to benefit from continued secukinumab therapy.
Other protocol-defined inclusion criteria apply. |
1. Los pacientes deben haber participado en el estudio principal CAIN457F2304 y deben haber completado todo el periodo de tratamiento hasta la semana 104, incluida. 2. Según el criterio del investigador, los pacientes deberán beneficiarse del tratamiento continuo con secukinumab
Para el resto de criterios de inclusión ver el protocolo. |
|
E.4 | Principal exclusion criteria |
1. Plans for administration of live vaccines during the extension study period. 2. Any patient taking other concomitant biologic immunomodulating agent(s) except secukinumab. 3. Any patient who is deemed not to be benefiting from the study treatment based upon lack of improvement or worsening of their symptoms.
Other protocol-defined exclusion criteria apply. |
1. Previsión de administración de vacunas vivas durante el periodo del estudio de extensión. 2. Cualquier paciente que tome otros fármacos inmunomoduladores biológicos concomitantes excepto secukinumab. 3. Cualquier paciente que no vaya a obtener beneficios del tratamiento del estudio basándose en la falta de mejoría o el empeoramiento de sus síntomas.
Para el resto de criterios de exclusión ver el protocolo. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
JIA ACR30 response |
Respuesta ACR30 en AIJ |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Until Week 308 visit. |
Hasta la visita de la semana 308 |
|
E.5.2 | Secondary end point(s) |
AEs, lab values, vital signs, Anti-Drug Antibodies (ADAs).
JIA ACR 50/70/90/100, JIA ACR Core Components, Inactive Disease Status, JADAS Score, Total Enthesitis count, Total Dactylitis count.
Secukinumab serum concentrations and derived PK parameters. |
AA, variables de laboratorio, constantes vitales, ADAs ACR/50/70/90/100 en AIJ, cada componente principal del ACR en AIJ, estado de enfermedad inactiva, Juvenile Arthritis Disease Activity Score (JADAS); recuento total de entesitis;recuento total de dactilitis. Concentraciones séricas Secukinumab y parámetros derivados de PK. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Until Week 308 visit. |
Hasta la visita de la semana 308 |
|
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 | No |
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 |
Immunogenicity |
Inmunogenicidad |
|
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | 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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
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 |
Poland |
Russian Federation |
South Africa |
Spain |
Turkey |
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
|
LVLS |
Último paciente, última visita |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial months | 6 |