E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ulcerative Colitis |
Colitis Ulcerosa |
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E.1.1.1 | Medical condition in easily understood language |
Ulcerative Colitis |
Colitis Ulcerosa |
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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 | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10009900 |
E.1.2 | Term | Colitis ulcerative |
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 |
To evaluate the Long-Term Safety and Efficacy of ABT-494 |
Evaluar la seguridad a largo plazo y la eficacia de ABT-494 |
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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 |
1. Subject has not responded at the end of the induction period (Week 8) in Study M14-234 (Substudies 1 and 2), who has been an inadequate responder during the maintenance period of Study M14-234 (Substudy 3), or who has responded and successfully completed Study M14-234. 2. If female, subject must meet the criteria as stated in Section 5.2.4 of this protocol: Contraception Recommendations and Pregnancy Testing. 3. Male subjects must agree to follow protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 90 days post last dose of study drug. 4. Subject is judged to be in otherwise good health as determined by the principal investigator based upon clinical evaluations performed during the preceding study (Study M14-234). 5. Must be able and willing to give written informed consent and to comply with the requirements of this study protocol. |
1. El paciente no ha respondido tras el periodo de inducción (Semana 8) en el estudio M14-234 (sub estudios 1 y 2), o ha tenido una respuesta inadecuada durante el periodo de mantenimiento del estudio M14-234 (sub estudio 3), o ha respondido y completado con éxito el estudio M14-234. 2. Si es mujer, la paciente tiene que cumplir con los criterios de la sección 5.2.4 de este protocolo: recomendaciones de contracepción y test de embarazo. 3. El paciente de sexo masculino tiene que estar de acuerdo en seguir las medidas del protocolo sobre evitar el embarazo, incluyendo evitar la donación de esperma durante y hasta 90 días después de la última dosis del fármaco de estudio. 4. Pacientes que tengan una buena salud determinado por el investigador principal basándose en las evaluaciones clínicas realizadas durante el estudio anterior (Estudio M14-234) 5. Debe ser capaz y estar dispuesto a dar su consentimiento informado por escrito y cumplir con los requerimientos del protocolo del este ensayo. |
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E.4 | Principal exclusion criteria |
1. For any reason subject is considered by the investigator to be an unsuitable candidate. 2. Female subject with a positive pregnancy test at Baseline (final visit of Study M14-234) or who is considering becoming pregnant during the study. 3. Subject with a poorly controlled medical condition, such as uncontrolled diabetes, unstable ischemic heart disease, moderate or severe congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the investigator or sponsor, would put the subject at risk by participation in this study. |
1. Por alguna razón el paciente es considerado un candidato no apto a criterio del investigador principal. 2. Las pacientes que tengan un resultado positivo en el test de embarazo en el momento basal (visita final del estudio M14-234) o que estén considerando quedarse embarazadas durante el estudio. 3. Pacientes con unas condiciones médicas poco controladas, como diabetes descontrolada, parada cardiaca isquémica inestable, fallos cardiacos congestivos moderados/severos, accidente cerebrovascular reciente y otras condiciones que, en opinión del investigador o del promotor, pongan al paciente en riesgo con su participación en el estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The clinical remission or response will be evaluated using the Mayo Scoring System for Assessment of Ulcerative Colitis Activity (Full Mayo score), Adapted Mayo score (Full Mayo score excluding Physician’s Global Assessment), or Partial Mayo score (Full Mayo score excluding endoscopic subscore). |
La remisión clínica, o la respuesta podrá ser evaluada usando el Índice de Mayo para la determinación de la actividad de la colitis ulcerosa (resultados completos de Mayo), Índice adaptado de Mayo todos los resultados del índice de Mayo excluyendo el asesoramiento global del Medico), o íncide parcial de Mayo ( esultados completos de Mayo excluyendo los sub-resultados endoscópicos). |
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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 | 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) | 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.8.3 |
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 | 130 |
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 |
Argentina |
Australia |
Belarus |
Bosnia and Herzegovina |
Brazil |
Canada |
Chile |
China |
Colombia |
Egypt |
European Union |
Israel |
Japan |
Kazakhstan |
Korea, Republic of |
Malaysia |
Mexico |
New Zealand |
Norway |
Puerto Rico |
Russian Federation |
Saudi Arabia |
Serbia |
Singapore |
South Africa |
Switzerland |
Taiwan |
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
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 27 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 27 |