E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
chronic non-infectious uveitis |
Uveítis crónica no infecciosa |
|
E.1.1.1 | Medical condition in easily understood language |
chronic non-infectious uveitis |
Uveítis crónica no infecciosa |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10022557 |
E.1.2 | Term | Intermediate uveitis |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10069034 |
E.1.2 | Term | Tubulointerstitial nephritis and uveitis syndrome |
E.1.2 | System Organ Class | 10038359 - Renal and urinary disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036370 |
E.1.2 | Term | Posterior uveitis |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071139 |
E.1.2 | Term | Behcet's uveitis |
E.1.2 | System Organ Class | 100000004866 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042745 |
E.1.2 | Term | Sympathetic uveitis |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012692 |
E.1.2 | Term | Diabetic uveitis |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10046851 |
E.1.2 | Term | Uveitis |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
|
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 long-term safety of gevokizumab in patient with chronic non-infectious uveitis who previously well tolerated the study drug and may benefit from longterm treatment with gevokizumab |
El objetivo primario de este estudio es evaluar la seguridad a largo plazo de gevokizumab en pacientes con uveítis crónica no infecciosa que previamente hayan tolerado bien el medicamento en investigación y que puedan beneficiarse del tratamiento con gevokizumab a largo plazo |
|
E.2.2 | Secondary objectives of the trial |
Not applicable |
No aplicable |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- either completed participation to one of the following : CL3-78989-002 open label extension, or X052130/CL3-78989-005 double masked period or open label period, or X052131/CL3-78989-006 double masked period or open label period, or currently benefiting from gevokizumab compassionate use after participation in gevokizumab uveitis studies, - Able to receive the first injection of gevokizumab within 6 weeks after the last study drug administration - Male or female, age ?18 (or legal age of majority in the country) at selection - For subjects with reproductive potential, a willingness to use highly effective contraceptive measures |
-Hombre o mujer, edad mayor o igual a 18 años (o mayoría de edad legal) en la visita de selección
-Hayan completado uno de los siguientes periodos: la extensión del periodo en abierto de CL3-78989-002, el periodo de doble enmascarado o periodo en abierto de X052130/CL3-78989-005 o X052131/CL3-78989-006 o que estén recibiendo gevokizumab como uso compasivo tras su participación en los estudios de uveítis -Capaces de recibir la primera inyección de gevokizumab en las 6 semanas posteriores a la última administración del medicamento en investigación -Para pacientes con potencial reproductivo, la voluntad de utilizar un método anticonceptivo altamente eficaz |
|
E.4 | Principal exclusion criteria |
- Meeting criteria for discontinuation of any of gevokizumab uveitis previous study. - Infectious uveitis and masquerade syndrome. - History of severe allergic or anaphylactic reaction to study drug administration during previous study or to gevokizumab or any of its excipient. - Currently active Infectious disease. |
- Que cumplan alguno de los criterios de retirada prematura de los estudios previos de uveítis con gevokizumab - Uveítis infecciosa y síndromes mascarada - Antecedente de alergia grave o reacción anafiláctica a la administración del medicamento en investigación durante el estudio previo, a gevokizumab o a alguno de sus excipientes - Enfermedad infecciosa activa |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Safety endpoints (adverse events assessment, vital signs, laboratory parameters, ophtalmological assessments,...) |
Objetivos de seguridad (evaluación de los acontecimientos adversos, signos vitales, parámetros de laboratorio, parámetros oftalmológicos, ...) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
-Adverse events and vital signs : From inclusion until the end of the study -laboratory parameters and ophtalmologic assessment : each 16 weeks from inclusion until the end of the study |
- Acontecimientos adversos y signos vitales: desde la visita de inclusión hasta el final del estudio - parámetros de laboratorio y evaluaciones oftalmológicas: cada 16 semanas desde la visita de inclusión hasta el final del estudio |
|
E.5.2 | Secondary end point(s) |
Not Applicable |
No aplicable |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
No aplicable |
|
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 | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 36 |
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 |
Armenia |
Australia |
Austria |
Brazil |
Canada |
China |
European Union |
France |
Germany |
Greece |
Hong Kong |
Israel |
Italy |
Korea, Republic of |
Mexico |
Poland |
Portugal |
Russian Federation |
South Africa |
Spain |
Taiwan |
Tunisia |
Turkey |
United Kingdom |
|
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
|
The end of trial is defined as the Last Visit of the Last Participant as stated in the clinical protocol. |
El final del ensayo se define como la última visita del último paciente como indica el protocolo |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
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 |