E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Uveítis no infecciosa intermedia, posterior o de todo el ojo (panuveítis). Non-infectious Intermediate-, Posterior-, or Pan-uveitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022557 |
E.1.2 | Term | Intermediate uveitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033687 |
E.1.2 | Term | Panuveitis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036370 |
E.1.2 | Term | Posterior uveitis |
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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 |
El objetivo principal de este estudio es evaluar la seguridad a largo plazo de adalimumab 40 mg administrado en semanas alternas por vía subcutánea (SC) en sujetos con uveítis no infecciosa intermedia, posterior o panuveítis que hayan participado en los estudios M10 877 o M10 880. También se evaluará la eficacia a largo plazo. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
El sujeto deberá haberse incluido con éxito en cualquiera de los estudios M10 877 o M10 880 y cumplir el criterio de valoración de fracaso del tratamiento o haber completado el estudio
Subject must have successfully enrolled in either Study M10-877 or Study M10-880 and either met the endpoint of "Treatment Failure" or completed the study. |
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E.4 | Principal exclusion criteria |
1. En este estudio se excluirá a los sujetos que se hayan retirado prematuramente de los estudios M10 877 o M10 880 por cualquier motivo distinto de sufrir un episodio de fracaso del tratamiento. 2. Sujetos con opacidad corneal o del cristalino que impida la visión del fondo del ojo o que probablemente requieran cirugía de cataratas durante el estudio. 3. Sujetos con una presión intraocular ≥ 25 mm Hg y que estén recibiendo ≥ 2 medicamentos para el glaucoma o que presenten signos de lesión glaucomatosa del nervio óptico. 4. Sujetos que tengan una mejor agudeza visual corregida (MAVC) inferior a 20/200 (logMAR de ETDRS > 1,0) en un ojo como mínimo. 5. Sujetos con retinopatía diabética no proliferativa intensa o proliferativa. 6. Sujetos con degeneración macular neovascular/húmeda relacionada con la edad. 7. Sujetos con anomalías de la interfaz vitreorretiniana (p. ej., tracción vitreomacular, membranas epirretinianas, etc.) que puedan causar lesión estructural macular independiente del proceso inflamatorio. 8. Sujetos que presenten enfermedad inflamatoria sistémica que requiera tratamiento con un agente inmunodepresor prohibido en el momento de entrar en el estudio.
? A subject will be excluded from this study if the patient prematurely discontinued from Study M10-877 or Study M10-880 for any reason other than having a Treatment Failure event. ? Subject with corneal or lens opacity that precludes visualization of the fundus or that likely requires cataract surgery during the duration of the trial. ? Subjects with intraocular pressure of more than or equal to 25 mmHg and more than or equal to 2 glaucoma medications or evidence of glaucomatous optic nerve injury. ? Subject with best corrected visual acuity (BCVA) worse than 20/200 (ETDRS logMAR > 1.0) in at least one eye. ? Subject with proliferative or severe non-proliferative diabetic retinopathy. ? Subject with neovascular/wet age-related macular degeneration. ? Subject with abnormality of vitreo-retinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) with the potential for macular structural damage independent of the inflammatory process. ? Subject with a systemic inflammatory disease that requires therapy with a prohibited immunosuppressive agent at the time of study entry. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Porcentaje de sujetos que en cada punto temporal del estudio no presentan una nueva lesión activa, inflamatoria coriorretiniana o retiniana en ambos ojos, con respecto al momento basal para los que presentaban uveítis inactiva cuando entraron en el estudio, y con respecto a la semana 8 para los que presentaban uveítis activa cuando entraron en el estudio. Porcentaje de sujetos que en cada punto temporal del estudio presenten células en la CA de grado ≤ 0,5+ en ambos ojos en el análisis con lámpara de hendidura, según los criterios del SUN. Porcentaje de sujetos que en cada punto temporal del estudio presenten turbidez en el vítreo de grado ≤ 0,5+ en ambos ojos en la oftalmoscopia indirecta según los criterios NEI/SUN. Porcentaje de sujetos que en cada punto temporal del estudio presenten un empeoramiento de la MAVC de ≥ 3 líneas / 15 letras en el ETDRS en ambos ojos, con respecto al momento basal en los sujetos que presentaban uveítis inactiva cuando entraron en el estudio, y con respecto a la semana 8 para los que presentaron uveítis activa cuando entraron en el estudio Cambio en el grosor de la retina central (subcampo de 1 mm) en cada ojo en cada punto temporal del estudio, con respecto al momento basal para los sujetos que presentaban uveítis inactiva cuando entraron en el estudio y a la semana 8 para los que presentaron uveítis activa cuando entraron en el estudio. Variación de la puntuación en el cuestionario de funcionamiento visual NEI (VFQ-25) en cada punto temporal del estudio, con respecto al momento basal para los sujetos que presentaban uveítis inactiva cuando entraron en el estudio y a la semana 8 para los que presentaban uveítis activa cuando entraron en el estudio. Porcentaje de sujetos que en cada punto temporal del estudio logren una reducción ≥ 50% de la carga de la inmunodepresión, con respecto al momento basal para los que presentaban uveítis inactiva cuando entraron en el estudio y a la semana 8 para los que presentaban uveítis activa cuando entraron en el estudio. La seguridad se evaluará mediante los acontecimientos adversos, los datos de laboratorio, la exploración física y las constantes vitales durante todo el estudio
Proportion of subjects at each study time point with no new active, inflammatory chorioretinal or inflammatory retinal vascular lesion in both eyes relative to Baseline for subjects who had inactive uveitis when they entered the study and to Week 8 for subjects who had active uveitis when they entered the study.
· Proportion of subjects at each study time point with a Grade <= 0.5+ in AC cells in both eyes on Slit Lamp Exam according to SUN criteria.
· Proportion of subjects at each study time point with a Grade <= 0.5+ in vitreous haze in both eyes on indirect ophthalmoscopy according to NEI/SUN criteria.
· Proportion of subjects at each study time point without a worsening of BCVA by >= 3 lines or 15 letters on the ETDRS in both eyes relative to Baseline for subjects who had inactive uveitis when they entered the study and to Week 8 for subjects who had active uveitis when they entered the study.
· Change in central retinal thickness (1 mm subfield) in each eye at each study time point relative to Baseline for subjects who had inactive uveitis when they entered the study and to Week 8 for subjects who had active uveitis when they entered the study.
· Change in NEI Visual Functioning Questionnaire (VFQ-25) score at each study time point relative to Baseline for subjects who had inactive uveitis when they entered the study and to Week 8 for subjects who had active uveitis when they entered the study.
· Proportion of subjects at each study time point achieving a >= 50% reduction in immunosuppression load relative to Baseline for subjects who had inactive uveitis when they entered the study and to Week 8 for subjects who had active uveitis when they entered the study.
· Safety will be assessed by adverse events, laboratory data, physical examinations and vital signs throughout the study. |
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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 | 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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
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 | Information not present in EudraCT |
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 |
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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
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El final del estudio se define como la fecha de la última visita programada del último sujeto o la fecha real del contacto de seguimiento, lo que ocurra más tarde.
The end-of-study is defined as the date of the last subject's last scheduled visit or the actual date of follow-up contact, whichever is later. |
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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 | 11 |
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 | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |