E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022557 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036370 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10033687 |
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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 |
The primary objective of this study is to evaluate the long-term safety of adalimumab 40 mg given every other week (eow) subcutaneously (SC) in subjects with non-infectious intermediate-, posterior-, or pan-uveitis who participated in Study M10-877 or Study M10-880. Long-term efficacy will also be assessed. |
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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 |
• Subject must have successfully enrolled in either Study M10-877 or Study M10-880 and either met the endpointof ``Treatment Failure`` or completed the study. |
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E.4 | Principal exclusion criteria |
• 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) |
• 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 ≥ 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. Other efficacy variables include: Work Productivity and Activity Impairment Questionnaire: Specific Health Problem Questionnaire (WPAI-SHP), EuroQol-5D Questionnaire (EQ-5D) and Health Resource Utilization Questionnaire (HRU). Other efficacy variables include: Work Productivity and Activity Impairment Questionnaire: Specific Health Problem Questionnaire (WPAI-SHP), EuroQol-5D Questionnaire (EQ-5D) and Health Resource Utilization Questionnaire (HRU). 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 | 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 | No |
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) | 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 | 3 |
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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La conclusione della sperimentazione e` definita come l`ultima visita dell`ultimo soggetto o come la data effettiva di follow-up, quale delle due avvenga piu` tardi nel tempo. |
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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 |