E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Crohn's Disease |
Enfermedad de Chron |
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E.1.1.1 | Medical condition in easily understood language |
Crohn's Disease |
Enfermedad de Chron |
|
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 | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013099 |
E.1.2 | Term | Disease Crohns |
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 |
To observe the long-term efficacy, safety, and tolerability of repeated administration of ABT-494 in subjects with Crohn's disease (CD) who completed Study M13-740. |
Para observar la eficacia a largo plazo, seguridad y tolerabilidad en la administración repetida de ABT-494 en pacientes con enfermedad de Crohn, los cuales han completado el estudio M13-740 |
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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 completed Study M13-740 through Week 52. |
Los sujetos deben haber completado el estudio M13-740 a lo largo de 52 semanas. |
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E.4 | Principal exclusion criteria |
• For any reason subject is considered by the investigator to be an unsuitable candidate • Female subject with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study. • Subject is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740. |
•Por ninguna razón el sujeto es considerado por el investigador como un candidato inadecuado • Los sujetos del sexo femenino que den positivo en un test de embarazo o que estén considerando quedarse embarazadas a lo largo del estudio •Sujeto que no esté conforme con la medicación anterior y concomitante requerida o los procedimientos a lo largo del Estudio M13-740. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Proportion of subjects achieving Remission at Week 0 (Week 52 of Study M13-740), Month 12 and Month 24. • Proportion of subjects in Remission at Week 0 who maintain remission at Month 12, and Month 24. • Proportion of subjects achieving Response at Week 0 (Week 52 of Study M13-740), Month 12, and Month 24. |
• Proporción de los sujetos que consigan una remisión en la semana 0 (semana 52 del estudio M13-740), mes 12 y mes 24. •Proporción de los sujetos en remisión en la semana 0 que mantengan la remisión en el mes 12 y en el mes 24 •Proporción de los sujetos que consigan una respuesta en la semana 0 ( semana 52 del estudio M13-740), mes 12 , y mes 24 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Every 12 months |
Cada 12 meses |
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E.5.2 | Secondary end point(s) |
• Proportion of subjects in Remission, and hs-CRP < 5 mg/L, and fecal calprotectin < 250 μg/g at Week 0 (Week 52 of Study M13-740), Month 12, Month 24, Month 36, Month 48, Month 60, Month 72, Month 84 and Month 96. |
• Proporción de los sujetos en remisión, y hs-CRP < 5 mg/L, y calprotectina fecal < 250 μg/g en la semana 0 (Semana 52 del Estudio M13-740), mes 12, mes 24, mes 36, mes 48, mes 60, mes 72, mes 84 y mes 96. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Every 12 months |
Cada 12 meses |
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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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 65 |
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 |
Australia |
Canada |
Israel |
New Zealand |
Puerto Rico |
United States |
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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
|
Last subject last visit, or the last follow-up contact, whichever is longer. |
La última visita del ultimo sujeto, o el último contacto de seguimiento, cualquiera que sea el periodo más extenso. |
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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 | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial months | 24 |
E.8.9.2 | In all countries concerned by the trial days | 0 |