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 | 16.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
|
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 based on ACR20 at 24 Weeks |
Eficacia de ixekizumab (LY2439821) comparado con placebo en participantes con artritis psoriásica basada en una respuesta ACR20 a las 24 semanas |
|
E.2.2 | Secondary objectives of the trial |
· Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on modified Total Sharp Score (mTSS) through 24 weeks · Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on ACR20 through 24 Weeks · Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on Non-Arthritic Disease Assessments through 24 Weeks · Efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis based on Patient Reported Outcomes (PROs) through 24 Weeks |
- Eficacia de ixekizumab (LY2439821) comparado con placebo en participantes con artritis psoriásica basada en el cambio del índice total de Sharp modificado (mTSS) durante 24 semanas - Eficacia de ixekizumab (LY2439821) comparado con placebo en participantes con artritis psoriásica basada en una respuesta ACR20 durante 24 semanas - Eficacia de ixekizumab (LY2439821) comparado con placebo en participantes con artritis psoriásica basada en Non Arthritic Disease Assesment durante 24 semanas - Eficacia de ixekizumab (LY2439821) comparado con placebo en participantes con artritis psoriásica basada en los Resultados Reportados por el Paciente (PROs) durante 24 semanas |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
? Presents with established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria ? Active psoriatic arthritis (PsA) 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 |
- Con un diagnóstico confirmado de APs desde un mínimo de 6 meses que cumplen los criterios CASPAR (clasificación para la artritis psoriásica) -Con APs activa, definida como la presencia de al menos 3/68 articulaciones dolorosas y 3/66 de articulaciones inflamadas, determinado mediante el formulario de evaluación del número de articulaciones dolorosas e inflamadas en la visita 1 (selección) y visita 2 (semana 0, periodo basal). - Con 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 fértiles que den negativo en la prueba de embarazo y 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, lo que dure más. |
|
E.4 | Principal exclusion criteria |
? Current or prior use of biologic agents for treatment of Ps or PsA ? Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (DMARDs) ? Current use of more than one conventional DMARD ? Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA ? Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab ? Serious disorder or illness other than psoriatic arthritis ? Serious infection within the 3 months prior to randomization ? Breastfeeding or nursing (lactating) women |
- Haber recibido, o estar recibiendo, cualquier tratamiento con FARMEb para la APs o terapia biológica para la Ps. - Haber tenido, en opinión del investigador, una respuesta insuficiente a ? 4 FARME convencionales o modificadores de la respuesta inmunitaria. - Haber utilizado FARME convencionales distintos de MTX, leflunomida, sulfasalazina, o hidroxicloroquina. - Haber completado o abandonado previamente este estudio o cualquier otro estudio de investigación de ixekizumab u otros inhibidores de la IL-17. - Tener diagnosticada otra artropatía inflamatoria como AR, espondilitis anquilosante, artritis reactiva (síndrome de Reiter) o síndrome de Felty. - Tener una enfermedad grave diferente a la artritis psoriásica -Tener o haber tenido una infección grave en los 3 meses anteriores a la aleatorización - Mujeres en periodo de lactancia |
|
E.5 End points |
E.5.1 | Primary end point(s) |
American College of Rheumatology 20 Index (ACR20) |
Índice ACR20 (American College of Rheumatology 20 Index) |
|
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) |
· modified Total Sharp Score (mTSS) · ACR20 · Non-Arthritic Disease Assessments · Patient Reported Outcomes (PRO) |
- índice total de Sharp modificado (mTSS) - ACR20 - Non-Arthritic Disease Assessments - Resultados reportados por el paciente (PROs) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline through 24 Weeks |
desde la visita basal a las 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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 12 |
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 |
Argentina |
Belgium |
Bulgaria |
Canada |
Czech Republic |
Estonia |
France |
Hungary |
Ireland |
Japan |
Mexico |
Netherlands |
Poland |
Russian Federation |
South Africa |
Spain |
Turkey |
Ukraine |
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 |
Final del estudio es la fecha de la última visita o la fecha del último procedimiento realizado al último paciente activo en el estudio, lo que sea más tarde |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |