E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Arthritic Psoriasis |
Artritis Psoriásica |
|
E.1.1.1 | Medical condition in easily understood language |
A type of arthritis associated with psoriasis |
Un tipo de Artritis asociada con Psoriasis |
|
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 | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
|
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 |
Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis who are biologic disease-modifying antirheumatic drugs (bDMARD0-experienced, as measured by the percentage of patients achieving ACR20 response at Week 24. |
Eficacia de ixekizumab (LY2439821) comparado con placebo en participantes con artritis psoriásica activa que están con tratamiento previo de fármaco antirreumático modificador de la enfermedad biológico, FARMEb, determinado mediante la proporción de pacientes que alcancen una respuesta ACR20 en la semana 24. |
|
E.2.2 | Secondary objectives of the trial |
? Efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis based on ACR20 through 24 Weeks ? Efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis based on Non-Arthritic Disease Assessments through 24 Weeks ? Efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis based on Patient Reported Outcomes (PROs) through 24 Weeks |
?Eficacia de ixekizumab en comparación con placebo en participantes con artritis psoriásica activa basada en ACR20 a través de 24 semanas ? Eficacia de ixekizumab comparado con placebo en participantes con la artritis psoriásica activa basándose en evaluaciones de enfermedad no-artrítica a través de 24 semanas ? Eficacia de ixekizumab en comparación con el placebo en participantes con artritis psoriásica activa basada en los Resultados comunicados por el paciente (RCP) a través de las 24 Semanas |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? Presents with established diagnosis of active psoriatic arthritis (PSA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria ? Active psoriatic arthritis defined as the presence of at least 3 tender and at least 3 swollen joints ? Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps) ? Men must agree to use a reliable method of birth control or remain abstinent during the study ? Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment ? Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs) |
?Tener un diagnóstico de APs activa durante al menos 6 meses y cumplir actualmente con los criterios de clasificación para la artritis psoriásica (CASPAR). ?Tener APs activa, definida como la presencia de al menos 3 articulaciones dolorosas y 3 articulaciones inflamadas. ?Presentar lesiones psoriásicas cutáneas activas (placas) o antecedentes documentados de Ps en placas. ?Pacientes de sexo masculino que accedan a utilizar un método anticonceptivo fiable durante el estudio. ?Mujeres que accedan a utilizar un método anticonceptivo fiable o practiquen la abstinencia durante el estudio y al menos 12 semanas después de la última dosis del producto en investigación. ?Haber sido tratado con 1 o más Fármacos antirreumáticos modificadores de la enfermedad (FARMEc). |
|
E.4 | Principal exclusion criteria |
? Current use of biologic agents for treatment of Ps or PsA ? Inadequate response to greater than 2 bDMARDs ? Current use of more than one cDMARD ? Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA ? Have received treatment with IL-17 or IL12/23 targeted MAb therapy ? Serious disorder or illness other than psoriatic arthritis ? Serious infection within the last 3 months ? Breastfeeding or nursing (lactating) women |
?Estar actualmente recibiendo tratamiento con cualquier tratamiento biológico o de moléculas pequeñas para la APs o la Ps. ?Respuesta inadecuada a más de 2 bDMARDs ?Uso actual de más de un cDMARD ?Diagnóstico de síndromes artritis inflamatorios activos o espondiloartropatías aparte de PsA ?Haber recibido un tratamiento con AcM dirigidos a IL-17 o IL12/23. ?Grave trastorno o enfermedad aparte de la artritis psoriásica ?Infección grave de los últimos 3 meses ?Mujeres en periodo de lactancia. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
American College of Rheumatology 20 Index (ACR20) |
Colegio Americano de Reumatología Indice 20 (ACR20) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At 24 Weeks |
A las 24 semanas |
|
E.5.2 | Secondary end point(s) |
? ACR20 ? Non-Arthritic Disease Assessments ? Patient Reported Outcomes (PRO) |
? ACR20 ? evaluaciones de enfermedad no-artrítica ? Resultados comunicados por el paciente (RCP) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline through 24 Weeks |
Desde la visita basal durante 24 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 | Yes |
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 | 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 | 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 | 8 |
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 |
Australia |
Czech Republic |
France |
Germany |
Israel |
Italy |
Poland |
Spain |
Taiwan |
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
|
End of the study is the date of the last visit or the last scheduled procedure for the last active subject in the study whichever is later |
El fin del estudio es la fecha de la última visita o el último procedimiento programado para el ultimo paciente activo en el estudio, lo que ocurra más tarde. |
|
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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 3 |