E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ulcerative Colitis |
Colitis Ulcerosa |
|
E.1.1.1 | Medical condition in easily understood language |
Ulcerative colitis is a type of inflammatory bowel disease that causes inflammation and sores (ulcers) in the lining of the rectum and colon. |
Colitis Ulcerosa es un tipo de enfermedad inflamatoria que causa inflamación y úlceras en las paredes del recto y colon |
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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 | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10017947 |
E.1.2 | Term | Gastrointestinal disorders |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
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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 |
Assess the effect of adalimumab on QOL as measured by the Short Inflammatory Bowel Disease (SIBDQ), the utilization of health care resources and the costs of care for the UC subjects treated with adalimumab. |
Evaluar el efecto de adalimumab en la CdV medido por el breve cuestionario de enfermedad inflamatoria intestinal, la utilización de los recursos sanitarios y el coste asistencial de los pacientes con colitis ulcerosa tratados con adalimumab. |
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E.2.2 | Secondary objectives of the trial |
Assess the effect of adalimumab on UC subjects' additional QOL measurements and disease activities, as well as to further characterize the safety profile of adalimumab. |
Evaluar la calidad de vida con medidas adicionales y la actividad de la enfermedad así como aportar más datos al perfil de seguridad de adalimumab |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects must be male or female between the ages of 18 and 75 years old at the time of the Screening Visit. 2. Subjects must have a diagnosis of Ulcerative Colitis (UC) greater than 90 days prior to Week 0 (Baseline) and failed conventional treatment. 3. Subjects' diagnosis of active UC must be confirmed by a colonoscopy with biopsy or flexible sigmoidoscopy with biopsy. 4. Subjects must have active UC with a Physicians Global Assessment (PGA) score of 2 or 3 and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) ? 45 at Week 0 (Baseline). 5. Subjects must be on a concurrent treatment with at least one of the following (oral corticosteroids or immunosuppressants or both as defined below): ? Stable oral corticosteroid dose (prednisone ? 20 mg/day or equivalent) for at least 14 days prior to Baseline. or ? Stable oral corticosteroid dose (prednisone < 20 mg/day) for at least 21 days prior to Baseline. and/or ? At least a consecutive 12 weeks (84 days) course of azathioprine or 6-mercaptopurine (6-MP) prior to Baseline.
Concurrent therapy will not be required for subjects who were previously treated with corticosteroids or immunosuppressants (azathioprine or 6-MP) and, in the judgment of the investigator, have failed to respond to or could not tolerate their treatment. |
1. Pacientes de ambos sexos de edades comprendidas entre 18 y 75 años en el momento de la visita de selección 2. Los pacientes deberán estar diagnosticados de CU desde más de 90 días antes de la semana 0 (momento basal) y no haber respondido al tratamiento convencional. 3. El diagnóstico de CU activa debe confirmarse mediante una colonoscopia con biopsia o una sigmoidoscopia flexible con biopsia (véanse los criterios de realización de la sigmoidoscopia flexible en la sección 5.3.1.1). 4. Los pacientes deberán tener CU activa con una puntuación PGA de 2 o 3 y un SIBDQ ? 45 en la semana 0 (momento basal). 5. Los pacientes deberán seguir un tratamiento simultáneo con al menos uno de los medicamentos siguientes (corticosteroides orales, inmunosupresores o ambos según se define a continuación): ? Dosis estable de un corticosteroide oral (prednisone ? 20 mg/día o equivalente) durante al menos 14 días antes de la visita basal o ? Dosis estable de un corticosteroide oral (prednisone < 20 mg/día o equivalente) durante al menos 21 días antes de la visita basal y/o ? Al menos un ciclo de azatioprina o 6-mercaptopurina (6-MP) de 12 semanas (84 días) consecutivas antes de la visita basal.
No es necesario el tratamiento concomitante en los pacientes tratados previamente con corticosteroides o inmunosupresores (azatioprina o 6-MP) y que, a juicio del investigador, no hayan respondido o no puedan tolerar el tratamiento. |
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E.4 | Principal exclusion criteria |
1. Subjects with a history of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch, Kock pouch, or ileostomy for UC or planned bowel surgery. 2. Subjects received previous treatment with an anti-tumor necrosis factor (TNF) agent (including infliximab or adalimumab) or previous participation in an adalimumab clinical study. 3. Subjects received cyclosporine, tacrolimus, or mycophenolate mofetil within 30 days of Week 0 (Baseline). 4. Subjects received intravenous (IV) corticosteroids within 14 days of Screening or during the Screening period. 5. Subjects with a current diagnosis of fulminant colitis and/or toxic megacolon. |
1. Pacientes con antecedentes de colectomía subtotal con ileorrectostomía o colectomía con reservorio ileoanal, bolsa de Kock o ileostomía por CU o cirugía intestinal prevista. 2. Pacientes que hayan recibido previamente tratamiento con un fármaco anti-TNF (incluidos infliximab o adalimumab) o que hayan participado en un estudio clínico de adalimumab. 3. Pacientes tratados con ciclosporina, tacrolimus o micofenolato mofetilo en los 30 días previos a la visita de la semana 0 (momento basal). 4. Pacientes tratados con corticosteroides intravenosos (IV) en los 14 días anteriores a la selección o durante el período de selección. 5. Pacientes con diagnóstico actual de colitis fulminante o megacolon tóxico. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change in SIBDQ at Week 26 from Baseline |
Variación en el SIBDQ de semana 26 con respecto a la Basal |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 0, Week 2, Week 8, Week 26/Premature Discontinuation |
Semana 0, semana 2, semana 8 semana 26/terminación prematura |
|
E.5.2 | Secondary end point(s) |
Key Secondary: ? Change (6 months after versus the previous 6 months) in costs of UC-related medical care excluding adalimumab costs ? Change (6 months after versus the past 6 months) in total all-cause direct health care costs ? Change (6 month after versus the past 6 months) in direct UC-related health care costs and indirect UC-related health care costs ? Reduction (6 months after versus the past 6 months) in UC-related and all-cause hospitalization ? Change in patient satisfaction (TSQM) at Week 26 from Baseline |
? Variación (después de 6 meses con respecto a los últimos 6 meses) de los costes de la asistencia médica de la CU excepto los costes de adalimumab ? Variación (después de 6 meses frente a los últimos 6 meses) del coste sanitario directo total por cualquier causa ? Variación (después de 6 meses frente a los últimos 6 meses) de los costes sanitarios directos e indirectos de la CU ? Reducción (después de 6 meses frente a los últimos 6 meses) de los ingresos hospitalarios por la CU y por cualquier causa ? Variación de la satisfacción del paciente (TSQM) en la semana 26 con respecto al valor basal |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 months prior to Baseline, Week 0, Week 2, Week 8, Week 26/Premature Discontinuation |
6 meses antes de la basal, Semana 0, semana 2, semana 8 semana 26/terminación prematura |
|
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 | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | 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 | 75 |
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 |
Austria |
Belgium |
Canada |
Denmark |
Finland |
France |
Germany |
Greece |
Ireland |
Israel |
Italy |
Netherlands |
Norway |
Portugal |
Spain |
Sweden |
Switzerland |
Turkey |
United Kingdom |
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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 the study is Week 26 or premature discontinuation. In addition, there will be a 70-day call/visit after the last dose of study drug. |
El final del estudio es semana 26 o una terminación prematura. Además, habrá una llamada/visita a los 70 días desde la última dosis del fármaco del estudio. |
|
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 | 3 |
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |