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 |
Colitis ulcerosa |
|
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 | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045365 |
E.1.2 | Term | Ulcerative colitis |
E.1.2 | System Organ Class | 100000004856 |
|
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 objective of the study is to evaluate the long-term safety, tolerability, and maintenance of clinical response, of repeated administration of adalimumab in pediatric subjects with ulcerative colitis who participated in, and successfully completed, Protocol M11-290 through Week 52. |
El objetivo del estudio es evaluar la seguridad, la tolerabilidad y el mantenimiento de la respuesta clínica a largo plazo de la administración repetida de adalimumab en sujetos pediátricos con colitis ulcerosa que participaron en el protocolo M11-290 y que lo completaron con éxito hasta la semana 52. |
|
E.2.2 | Secondary objectives of the trial |
|
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 |
Serologic markers |
Marcadores serológicos |
|
E.3 | Principal inclusion criteria |
Subject must have successfully enrolled in and completed Protocol M11-290 through Week 52. |
El sujeto debe haber sido incluido en y completado con éxito hasta la semana 52 el protocolo M11-290 |
|
E.4 | Principal exclusion criteria |
Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for continuing therapy in the Study M10-870. |
El sujeto es considerado por el investigador, por cualquier razón, que no es un candidato para continuar la terapia del estudio M11-290 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
This study will utilize the PMS (and Mayo score if available) and PUCAI to determine efficacy of the study drug |
En este estudio se usará la PMS (y la puntuación en la escala Mayo si se dispone de ella) y el PUCAI para determinar la eficacia del fármaco del estudio. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96/Premature Discontinuation |
Visita basal y las visitas de las semanas 4, 8, 12, 24, 36, 48, 60, 72, 84 y 96 o en la visita de retirada del estudio |
|
E.5.2 | Secondary end point(s) |
Safety analyses will be performed on all subjects who receive at least one dose of study drug. |
Los análisis de la seguridad se llevarán a cabo en todos los sujetos que reciban al menos una dosis del estudio. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84 and 96/Premature Discontinuation |
Visita basal y las visitas de las semanas 4, 8, 12, 24, 36, 48, 60, 72, 84 y 96 o en la visita de retirada del estudio |
|
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 | 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 | 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 | 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 | Yes |
E.8.1.7.1 | Other trial design description |
Estudio de extension abierto |
Open label extension study |
|
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 43 |
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 |
Japan |
New Zealand |
United States |
|
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 fin del estudio se define como la fecha de la última visita del último paciente, o el últimos contacto de seguimiento, lo que sea más largo. |
|
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 | 2 |
E.8.9.1 | In the Member State concerned days | 15 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 15 |