E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rheumatoid arthritis |
Artritis Reumatoide |
|
E.1.1.1 | Medical condition in easily understood language |
Rheumatoid arthritis |
Artritis Reumatoide |
|
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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039073 |
E.1.2 | Term | Rheumatoid 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 with respect to ACR20, ACR50 and ACR70 response over time up to Month 60 in patients who completed the phase III study CAIN457F2309 |
Evaluar la eficacia a largo plazo de secukinumab con respecto a la respuesta ACR20, ACR50 y ACR70 con el tiempo hasta el Mes 60 en pacientes que hayan finalizado el estudio de fase III CAIN457F2309. |
|
E.2.2 | Secondary objectives of the trial |
1) To evaluate the long-term efficacy of secukinumab with respect to changes in HAQ-DI relative to baseline over time up to Month 60
2) To evaluate the long-term efficacy of secukinumab with respect to the proportion of subjects achieving major clinical response (continuous six-month period of ACR70 response) over time up to Month 60
3) To evaluate the long-term efficacy of secukinumab with respect to the changes in DAS28 relative to baseline over time up to Month 60 |
1. Evaluar la eficacia a largo plazo de dos dosis diferentes de secukinumab en cuanto a los cambios en el HAQ-DI respecto a la visita basal con el tiempo hasta el Mes 60 2. Evaluar la eficacia a largo plazo de dos dosis diferentes de secukinumab en lo que respecta a la proporción de pacientes que alcancen una respuesta clínica considerable (periodo continuo de seis meses de respuesta ACR70) con el tiempo hasta el Mes 60 3. Evaluar la eficacia a largo plazo de dos dosis diferentes de secukinumab en cuanto a los cambios en la DAS28 respecto a la visita basal con el tiempo hasta el Mes 60 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Subjects who provide a written, signed and dated informed consent before any study assessment is performed
2) Subjects must have participated in phase III study CAIN457F2309, must have completed the entire treatment period and must have received secukinumab during phase III study (either from start of phase III study or after re-assignment to one of the secukinumab arms after week 16/24)
3) Subjects who are deemed by the investigator to benefit from continued secukinumab therapy |
1. Los pacientes deben ser capaces de comprender y comunicarse con el investigador y cumplir los requisitos del estudio y deberán otorgar su consentimiento informado firmado y fechado por escrito antes de que se realice ninguna de las evaluaciones del estudio. 2. Los pacientes deben haber participado en el estudio de fase III CAIN457F2309, deben haber completado el periodo completo de tratamiento y deben haber recibido secukinumab durante el estudio de fase III (ya sea desde el inicio del estudio de fase III o tras haber sido reasignados a uno de los brazos de secukinumab después de la semana 16/24) 3. Pacientes que el investigador considere que se benefician de la terapia continuada con secukinumab |
|
E.4 | Principal exclusion criteria |
1) Any subject taking other concomitant biologic immunomodulating agent(s) except secukinumab
2) Any subject who is deemed not to be benefiting from the study drug based upon lack of improvement or worsening of their symptoms
3) Any subject who continued to receive abatacept after week 16 during the phase III study CAIN457F2309
Other protocol-defined exclusion criteria may apply |
1. Cualquier paciente que esté tomando otro(s) fármaco(s) inmunomodulador(es) biológico(s) concomitante(s), excepto secukinumab 2. Cualquier paciente que se considere que no se está beneficiando de la medicación del estudio en base a la falta de mejoría o al empeoramiento de sus síntomas.
Ver otros criterios de exclusion en el protocolo. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
ACR 20, 50 and 70 |
ACR 20, 50 y 70 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Over the entire duration of the study up to Month 60 |
Durante toda la duración del ensayo hasta el Mes 60 |
|
E.5.2 | Secondary end point(s) |
1) Questionnaire Disability Index (HAQ-DI) 2) Major clinical response 3) DAS28 |
1) Cuestionario Indice de discapacidad (HAQ-DI) 2) Respuesta clínica mayor 3) DAS28 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Over the entire duration of the study up to Month 60 |
Durante toda la duración del ensayo hasta el Mes 60 |
|
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 | 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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 71 |
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 |
Brazil |
Bulgaria |
Canada |
Colombia |
Czech Republic |
France |
Germany |
Hungary |
Italy |
Mexico |
Romania |
Russian Federation |
Slovakia |
Spain |
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 |
Ultima visita del ultimo paciente |
|
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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |