E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ulcerative colitis |
Colitis Ulcerosa |
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E.1.1.1 | Medical condition in easily understood language |
Ulcerative colitis |
Colitis Ulcerosa |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
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 | 10045365 |
E.1.2 | Term | Ulcerative colitis |
E.1.2 | System Organ Class | 100000004856 |
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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 is to evaluate safety and efficacy of higher induction and maintenance dosing regimens in subjects with moderately to severely active Ulcerative Colitis (UC). |
El objetivo principal del estudio es evaluar la seguridad y eficacia de pautas posológicas más altas de inducción y mantenimiento en pacientes con colitis ulcerosa moderada o muy activa |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacogenetic testing |
Estudio farmacogenético |
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E.3 | Principal inclusion criteria |
1)Subject is between the ages of 18 to 75 years 2) Diagnosis of UC for at least 90 days, confirmed by endoscopy with biopsy during the Screening Period 3) Active ulcerative colitis with a Mayo Score of 6 ? 12 points and endoscopy subscore of 2 ? 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both |
1)Pacientes de ambos sexos con una edad comprendida entre ? 18 y ? 75 años en la visita inicial 2) Paciente con un diagnóstico de CU durante 90 días o más antes de iniciar el tratamiento del estudio, confirmado mediante endoscopia con biopsia durante el período de selección 3)CU activa con una puntuación Mayo de 6 a 12 puntos y subpuntuación endoscópica de 2 a 3 (confirmada por el lector central) a pesar del tratamiento concurrente con corticoestoroidoes orales o inmunodepresores o ambos. |
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E.4 | Principal exclusion criteria |
1. Subject with Crohn's disease (CD) or indeterminate colitis (IC). 2. Current diagnosis of fulminant colitis and/or toxic megacolon. 3. Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy. 4. Chronic recurring infections or active TB |
1. Paciente con diagnóstico y/o antecedentes de enfermedad de Crohn (EC) o diagnóstico de colitis indeterminada (CI). 2.Diagnóstico actual de colitis fulminante y/o megacolon tóxico 3.Paciente con enfermedad limitada al recto (proctitis ulcerosa) en la endoscopia de selección. 4. Infecciones crónicas recurrentes o TB activa. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects achieving clinical remission (per Full Mayo Score) at Week 8 |
La variable principal de la eficacia es la proporción de pacientes que alcanzan la remisión clínica (según la puntuación Mayo total) en la semana 8. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Proportion of subjects achieving endoscopic improvement (endoscopic subscore of 0 or 1) at Week 8. 2. Proportion of Week 8 responders (per Full Mayo Score) achieving clinical remission (per Full Mayo Score) at Week 52. 3. Proportion of Week 8 responders (per Full Mayo Score) achieving endoscopic improvement (endoscopic subscore of 0 or 1) at Week 52. |
1.Proporción de pacientes que alcanzan una mejora endoscópica (subpuntuación endoscópica de 0 o 1) en la semana 8. 2. Proporción de respondedores en la semana 8 (según la puntuación Mayo total) que alcanzan la remisión clínica (según la puntuación Mayo total) en la semana 52. 3. Proporción de respondedores en la semana 8 (según la puntuación Mayo total) que alcanzan una mejora endoscópica (subpuntuación endoscópica de 0 o 1) en la semana 52. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 8 and week 52 |
Semana 8 y Semana 52 |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
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 | 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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Other doses of adalimumab |
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E.8.2.4 | Number of treatment arms in the trial | 5 |
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 | 97 |
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 |
Israel |
Japan |
Switzerland |
United States |
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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
|
The end of study is defined as the date of the Last subject last visit, or the last follow-up contact, whichever is longer. |
El final del estudio está definido como la fecha de la última visita del último paciente o el último contacto de seguimiento, lo que sea más largo. |
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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 | 6 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 4 |