E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Axial Spondyloarthritis |
Espondiloartritis axial radiografica |
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E.1.1.1 | Medical condition in easily understood language |
Chronic Inflammatory disease affecting the spine and sacroiliac joint. It is characterized by pain and stiffness of joints. |
Condicion inflamatoria crónica que afecta a la articulación sacroiliaca y espinal. Se caracteriza por dolor y rigidez en las articulaciones. |
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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 | 10041672 |
E.1.2 | Term | Spondylitis ankylosing |
E.1.2 | System Organ Class | 100000004859 |
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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 evaluate in patients having achieved a state of sustained remission whether the ixekizumab treatment group is superior to the placebo group in maintaining response during the randomized-withdrawal period |
Evaluar en pacientes que hayan alcanzado un estado de remisión sostenida si los grupos de tratamiento con ixekizumab combinados son superiores al grupo del placebo desde el punto de vista del mantenimiento de la respuesta durante el período aleatorizado de retirada-retratamiento |
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E.2.2 | Secondary objectives of the trial |
-To compare the combined ixekizumab treatment group to historical control for 2-year radiographic progression in spine in patients with active radiographic axSpA -To evaluate in patients having achieved a state of sustained remission whether the ixekizumab 80 mg every 2 weeks (Q2W) treatment group or ixekizumab 80 mg every 4 weeks (Q4W) treatment group is superior to placebo in maintaining response -To evaluate in patients having achieved a state of sustained remission whether the combined ixekizumab treatment group is superior to the placebo group in maintaining response after treatment withdrawal -To evaluate in patients having achieved a state of sustained remission whether the ixekizumab 80 mg Q2W treatment group or ixekizumab 80 mg Q4W treatment group is superior to placebo in maintaining response after treatment withdrawal |
-Comparar los grupos de tto. con ixekizumab combinados con el control histórico, en lo que respecta a la progresión radiológica en la columna vertebral al cabo de 2 años, en pacientes con EpAax radiológica. -Evaluar en pacientes que hayan alcanzado un estado de remisión sostenida si el grupo de tto. con 80 mg de ixekizumab cada 2 semanas (C2S) o el grupo de tratamiento con 80 mg de ixekizumab cada 4 semanas (C4S) es superior al grupo del placebo en el mantenimiento de la respuesta. -Evaluar en pacientes que hayan alcanzado un estado de remisión sostenida si los grupos de tto. con ixekizumab combinados son superiores al grupo del placebo en el mantenimiento de la respuesta tras la retirada del tratamiento. -Evaluar en pacientes que hayan alcanzado un estado de remisión sostenida si el grupo de tto. con 80 mg de ixekizumab C2S o el grupo de tratamiento con 80 mg de ixekizumab C4S es superior al grupo del placebo en el mantenimiento de la respuesta tras la retirada del tto. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Have completed the final study visit in Study RHBV, RHBW, or RHBX. (Note: Patients from Study RHBX are not eligible if they permanently discontinued ixekizumab and were receiving a TNF inhibitor). 2.Must agree to use a reliable method of birth control. 3.Have given written informed consent. |
1. Haber completado la visita final del Estudio RHBV, RHBW, o RHBX. (Nota: Los pacientes que vengan del RHBX no son elegibles si discontinuaron permanentemente el ixekizumab y estuvieron recibiendo un inhibidor TNF). 2.Debe estar de acuerdo en aceptar un metodo fiable de control de natalidad. 3.Haber dado el consentimiento informado por escrito. |
|
E.4 | Principal exclusion criteria |
-Have significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous ixekizumab study that, in the opinion of the investigator, pose an unacceptable risk to the patient if investigational product continues to be administered. -Have a known hypersensitivity to ixekizumab or any component of this investigational product. -Had investigational product permanently discontinued during a previous ixekizumab study. -Had temporary investigational product interruption at any time during or at the final study visit of a previous ixekizumab study and, in the opinion of the investigator, restarting ixekizumab poses an unacceptable risk for the patient’s participation in the study. -Have any other condition that, in the opinion of the investigator, renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol -Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study. |
-Tener importantes trastornos cerebro-cardiovasculares, respiratorios, hepáticos, renales, gastrointestinales, endocrinos, hematológicos, neuropsiquiátricos o valores anormales de laboratorio que se desarrollaron durante un estudio previo de ixekizumab que, a juicio del investigador, suponen un riesgo inaceptable para el paciente si este medicamento en investigación sigue siendo administrado. -Poseer hipersensibilidad conocida al ixekizumab o a cualquier componente de este medicamento en investigación. -Haber discontinuado permanentemente el medicamento en investigación durante un estudio previo con ixekizumab. -Haber tenido una interrupción temporal del medicamento en investigacion en cualquier momento durante o en la visita final de un estudio previo de ixekizumab, y que a juicio del investigador, suponga un riesgo inaceptable para la participación del paciente en el studio. -Tener alguna otra condición que, a juicio del investigador, haga al paciente incapaz de comprender la naturaleza, el alcance y las posibles consecuencias del estudio o que impida al paciente continuar y completar el protocol. -Estar actualmente participando en cualquier otro ensayo clínico que incluya un medicamento en investigación o en cualquier otro tipo de investigación médica que se valore científica o médicamente como no compatible con este estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of patients in the randomized withdrawal population who do not experience a flare during the randomized withdrawal retreatment period |
Porcentaje de pacientes en la población de retirada aleatorizada que no experimenten una exacerbación durante el período aleatorizado de retirada-retratamiento. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
-Change in modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS score) -The proportion of patients in the randomized withdrawal population who do not experience a flare during the randomized withdrawal-retreatment period -Time to flare during the randomized withdrawal-retreatment period -Time to flare during the randomized withdrawal-retreatment period |
-Variación en la puntuación de la escala Stoke modificada de espondilitis anquilosante en la columna (mSASSS) -Porcentaje de pacientes en la población de retirada aleatorizada que no experimenten una exacerbación durante el período aleatorizado de retirada-retratamiento. -Tiempo transcurrido hasta la exacerbación durante el período aleatorizado de retirada-retratamiento. -Tiempo transcurrido hasta la exacerbación durante el período aleatorizado de retirada-retratamiento. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | 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 | 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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 6 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 67 |
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 |
Austria |
Brazil |
Canada |
Czech Republic |
Finland |
France |
Germany |
Hungary |
Israel |
Italy |
Japan |
Korea, Democratic People's Republic of |
Mexico |
Netherlands |
Poland |
Puerto Rico |
Romania |
Russian Federation |
Spain |
Taiwan |
United Kingdom |
United States |
|
E.8.7 | Trial has a data monitoring committee | No |
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 ultimo paciente |
|
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 | 6 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |