E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Giant cell arteritis |
Arteritis de células gigantes |
|
E.1.1.1 | Medical condition in easily understood language |
Giant cell arteritis |
Arteritis de células gigantes |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018250 |
E.1.2 | Term | Giant cell arteritis |
E.1.2 | System Organ Class | 100000004866 |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The objective of this study is to evaluate the efficacy and safety of gevokizumab on symptoms of giant cell arteritis (GCA) in relapsing patients receiving systemic oral corticosteroids (CS) |
El objetivo de este estudio es evaluar la eficacia y seguridad de gevokizumab en los síntomas de la arteritis de células gigantes ( ACG ) de pacientes con recaída que reciban corticoterapia sistémica oral |
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E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Relapsing GCA with systemic symptoms, - Diagnosis of GCA according to ACR criteria and at least one previous GCA relapse, - Oral CS therapy, - Male or female, age ? 50 years, - Weight > 40 kg at selection, - For subjects with reproductive potential, a willingness to use highly effective contraceptive measures. |
- ACG recidivantes con síntomas sistémicos - Diagnóstico de ACG de acuerdo con los criterios ACR y con al menos una recaída previa, - Corticoterapia oral - Hombres o mujeres de edad > 50 años , - Peso > 40 kg en la selección - Para sujetos fértiles, la voluntad de utilizar métodos anticonceptivos altamente eficaces |
|
E.4 | Principal exclusion criteria |
- relapse of GCA with symptoms indicative of a risk of ischemic event, - History of recent, permanent or transient visual loss due to GCA and the presence of any specific visual abnormality, - History of major ischemic event, unrelated to GCA, - History of fibromyalgia, - Evidence of active pulmonary infection, active TB disease, or malignancy, or suspicion of active or latent TB, or exposition to TB, - History of severe allergic or anaphylactic reactions to monoclonal antibodies, - History of malignancy within 5 years prior to selection, - Known immunodeficiency, - Infectious disease, - Pregnancy, breastfeeding or possibility to become pregnant during the study |
- recaída de ACG cuyos síntomas denoten riesgo de isquemia - Antecedentes de ceguera reciente, permanente o transitoria debida a ACG y la presencia de cualquier anomalía visual específica - Episodio isquémico importante, no relacionado con la CGA - Antecedentes de fibromialgia - Evidencia de infección pulmonar activa, tuberculosis activa o neoplasia o sospecha de TB activa o latente o exposición a la TB . - Antecedentes de reacción alérgica o anafilactica grave a los anticuerpos monoclonales - Antecedentes de neoplasis maligna en los 5 años anteriores a la selección - Inmunodeficiencia conocida - Embarazo, lactancia o posibilidad de quedar embarazada durante el estudio |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Proportion of responders to treatment, - Physician Global Assessment, - Patient Global Assessment, - PMR activity score (PMR-AS), - Quality of life (SF-36), - Inflammation markers, - Corticosteroids use. |
- Proporción de respondedores al tratamiento - Evaluación global del médico - Evaluación global del paciente - Indice de actividad PMR ( PMR-AS) - Calidad de vida ( SF-36 ) - Marcadores inflamatorios - uso de corticoides |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Response to treatment: at week 4, Physician/Patient Global Assessment, PMR-AS, inflammation markers, remission, CS use: at each visit from selection to end of study visit, SF-36 : at week 0, week 4, week 12, week 24, week 36 and end of study visit |
Respuesta al tratamiento: en W4, Evaluación global del paciente /médico, PMR-AS, marcadores inflamatorios, remisión, uso de CS: en cada visita desde seleción hasta el final de las visitas de estudio, SF-36: en semana 0, semana 4, semana 12, semana 24, semana 36 y al final del estudio |
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E.5.2 | Secondary end point(s) |
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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 | 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 | No |
E.6.11 | Pharmacogenomic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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 |
Canada |
Australia |
Russian Federation |
|
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 del ultimo paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |