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 | 17.0 |
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 evaluate the long-term efficacy, safety, and tolerability of repeated administration of adalimumab in subjects with Crohn's disease (CD). |
El objetivo principal de este estudio es evaluar la eficacia, la seguridad y la tolerabilidad a largo plazo de la administración repetida de adalimumab en pacientes con enfermedad de Crohn (EC) que participaron en el estudio M14-115 y lo completaron satisfactoriamente. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to assess pharmacokinetics (PK) and immunogenicity of adalimumab following subcutaneous (SC) administration. |
El objetivo secundario es evaluar la farmacocinética (FC) y la inmunogenia de adalimumab después de la administración subcutánea (s.c.). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subject successfully enrolled in and completed Study M14-115, including the Week 12 ileocolonoscopy. |
El paciente deberá haber estado incluido y completado satisfactoriamente el estudio M14-115, incluida la ileocolonoscopia de la semana 12. |
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E.4 | Principal exclusion criteria |
1) If the Week 12 (Study M14 115) colonoscopy shows evidence of dysplasia or a malignancy. 2) Subject is not in compliance with prior and concomitant medication requirements throughout Study M14-115. 3) Subject who developed active Tuberculosis (TB) during Study M14-115, or subject who is non compliant with prophylaxis for latent TB initiated per Study M14-115 procedures. |
1) El paciente no debe inscribirse en el estudio si la colonoscopia realizada en la semana 12 (estudio M14 115) muestra signos de displasia o un proceso maligno; 2) El paciente no cumple los requisitos de medicación previa y concomitante en el estudio M14-115; 3) Paciente que desarrolle una tuberculosis (TB) activa durante el estudio M14-115, o paciente que no cumple con la profilaxis de TB latente iniciada según los procedimientos del estudio M14-115. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects with endoscopic improvement at Week 40 among subjects with endoscopic improvement at Week 0 of Study M14-347. |
Porcentaje de pacientes con mejoría endoscópica, definida como un SES-CD ? 4 con una subpuntuación de superficie ulcerada no mayor de 1 en cualquier segmento en la semana 40 en los pacientes con mejoría endoscópica en la semana 0 del estudio M14-347. |
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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) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 57 |
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 |
Ukraine |
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. |
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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 | 1 |
E.8.9.1 | In the Member State concerned days | |
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 | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |