E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Crohn's disease |
Enfermedad de Crohn |
|
E.1.1.1 | Medical condition in easily understood language |
Crohn's disease |
Enfermedad de Crohn |
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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 | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011401 |
E.1.2 | Term | Crohn's disease |
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 |
The primary objective of this study is to assess the efficacy and safety of two adalimumab induction regimens in achieving clinical remission at Week 4 and endoscopic improvement at Week 12 in subjects with moderately to severely active Crohn's disease and evidence of mucosal ulceration. |
El objetivo principal de este estudio es evaluar la eficacia y seguridad de dos pautas de inducción con Adalimumab en lograr la remisión clínica en la semana 4 y una mejoría en la endoscopia en la Semana 12 en pacientes con enfermedad activa de Crohn de moderada a severa y evidencia de ulceración de la mucosa |
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E.2.2 | Secondary objectives of the trial |
? To assess the safety and efficacy of two adalimumab induction regimens in reducing signs and symptoms of Crohn's disease at Week 12. ? To assess pharmacokinetics (PK) and immunogenicity of two adalimumab induction regimens following subcutaneous (SC) administration. |
Evaluar la seguridad y eficacia de dos pautas de inducción con Adalimumab en la disminución de los signos y síntomas de la enfermedad de Crohn en la semana 12.
Evaluar la farmacocinética (FC) e inmunogenia de dos pautas de inducción con adalimumab después de la administración subcutánea (SC) . |
|
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 |
Prueba farmacogenetica |
|
E.3 | Principal inclusion criteria |
1)Subject is between the ages of 18 to 75 years 2) Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during the Screening Period 3) Active CD with a Crohn's Disease Activity Index (CDAI) ? 220 and ? 450 despite treatment with oral corticosteroids and/or immunosuppressants 4) Mucosal ulceration on endoscopy |
1) Varones y mujeres con una edad comprendida entre ? 18 y ? 75 años antes de iniciar el tratamiento del estudio.
2) Diagnóstico de enfermedad de Crohn colónica, ileocolónica o ileal durante 3 meses o más antes de iniciar el tratamiento del estudio y confirmada mediante endoscopia durante el período de selección.
3) Activa Enfermedad de Crohn con Índice de Actividad (CDAI) ? 220 y ? 450 a pesar del tratamiento con corticoides orales e inmunodepresores.
4) Ulceración de la mucosa en la Endoscopia |
|
E.4 | Principal exclusion criteria |
1) Subject with ulcerative colitis or indeterminate colitis 2) Subject who has had surgical bowel resections within the past 6 months or is planning resection 3) Subject with an ostomy or ileoanal pouch 4) Subject with bowel stricture or abdominal or peri-anal abscess 5) Subject who has short bowel syndrome 6) Chronic recurring infections or active TB |
1) El paciente tiene un diagnóstico actual de colitis ulcerosa o colitis indeterminada. 2) El paciente se ha sometido a resecciones quirúrgicas intestinales en los últimos 6 meses o se está planificando una resección en algún momento mientras está inscrito en el estudio. 3) El paciente tiene una estenosis intestinal. 4) El paciente tiene un absceso abdominal o perianal. 5) El paciente tiene una ostomía o bolsa ileoanal 6) El paciente tiene TB activa. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects who achieve clinical remission at Week 4 and proportion of subjects who achieve endoscopic response at Week 12. |
Proporción de pacientes que logran la remisión clínica en la semana 4 y porcentaje de pacientes que han conseguido una respuesta en la endoscopia en la semana 12. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Week 4 and Week 12 |
Semana 4 y Semana 12 |
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E.5.2 | Secondary end point(s) |
1. Clinical remission at Week 12. 2. Proportion of subjects who discontinued corticosteroid use and achieved clinical remission at Week 12. 3. Proportion of subjects with clinical response at Week 4. 4. Proportion of subjects with clinical response at Week 12. 5. Proportion of subjects with endoscopic response at Week 12. 6. Change in IBDQ from Baseline at Week 4. 7. Change in IBDQ from Baseline at Week 12. |
1. Remisión clínica en la semana 12 2. Proporción de pacientes con respuesta endoscópica en la semana 12. 3. Proporción de pacientes con respuesta clínica en la semana 4. 4. Porcentaje de pacientes con respuesta clínica en semana 12. 5. Proporción de pacientes con respuesta endoscópica en la semana 12.. 6. Cambio en el cuestionario IBDQ con respecto al inicio en la semana 4. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 4 and 12 depending on the endpoints |
Semana 4 y 12 dependiendo de los endpoints |
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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 | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
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 | 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 |
dos pautas de inducción con Adalimumab |
two adalimumab induction regimens |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 32 |
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 |
European Union |
Israel |
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 | 1 |
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 | 1 |
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 |