E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Crohn's disease |
Enfermedad de Crohn |
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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 | 18.0 |
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 investigate long-term safety of BI 655066, in patients with moderately to severely active Crohn`s disease, who showed a clinical response or remission on previous treatment with BI 655066 and are now receiving long term treatment. |
Investigar la seguridad a largo plazo de BI 655066 en pacientes con enfermedad de Crohn activa de moderada a grave, que mostraron respuesta o remisión clínicas con el tratamiento previo con BI 655066 y que ahora reciben tratamiento a largo plazo. |
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E.2.2 | Secondary objectives of the trial |
To further investigate long-term efficacy, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of BI 655066. |
Seguir investigando la eficacia, la tolerabilidad, la farmacocinética, la farmacodinámica y la inmunogenicidad de BI 655066 a largo plazo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients with Crohn`s disease, who have successfully completed the preceding trial 1311.6. Successful treatment is defined as: a. Completion of period 2 in 1311.6 with a clinical response (drop in Crohn's Disease Activity Index from baseline by =100) but no remission (Crohn's Disease Activity Index < 150) at Visit E1; or b. Completion of period 3 in 1311.6 with a clinical response (drop in Crohn's Disease Activity Index from baseline by =100) or remission (Crohn's Disease Activity Index < 150) at Visit E5; or c. Completion of period 2 or 3 in 1311.6 per protocol with a clinical response or remission before initiation of 1311.20 can roll-over either directly or through an open-label i.v. re-induction phase. - Female patients: a. Women of childbearing potential (not surgically sterilized and between menarche and 1 year postmenopause), that, if sexually active agree to use one of the appropriate medically accepted methods of birth control in addition to the consistent and correct use of a condom from date of screening until 15 weeks after last administration of study medication. Medically accepted methods of contraception are: ethinyl estradiol containing contraceptives, diaphragm with spermicide substance, and intra-uterine-device, or b. Surgically sterilized female patients with documentation of prior hysterectomy, tubal ligation or complete bilateral oophorectomy, or c. Postmenopausal women with postmenopausal is defined as permanent cessation = 1 year of previously occurring menses, and d. Negative serum ß-Human Chorionic Gonadotrophin test at screening and urine pregnancy test prior to randomization. Male patients: a. Who are documented to be sterile, or b. Who consistently and correctly use effective method of contraception (i.e. condoms) during the study and 15 weeks after last administration of study medication. - Be able to adhere to the study visit schedule and other protocol requirements. |
1. Pacientes con enfermedad de Crohn que han finalizado con éxito el estudio 1311.6 anterior. El éxito del tratamiento se define como: - Finalización del periodo 2 en 1311.6 con respuesta clínica (descenso en la puntuación del CDAI respecto al periodo basal ? 100), pero sin remisión (CDAI < 150) en la visita E1; o - Finalización del periodo 3 en 1311.6 con respuesta clínica (descenso en la puntuación del CDAI respecto al periodo basal ? 100) o remisión (CDAI < 150) en la visita E5; o - Finalización del periodo 2 o 3 en 1311.6, según el protocolo, con respuesta o remisión clínicas antes del inicio de 1311.20. Los pacientes pueden continuar directamente o pasar por una fase de reinducción con tratamiento i.v. en abierto.
2. Mujeres: a. Mujeres potencialmente fértiles (no esterilizadas quirúrgicamente y entre la menarquia y un año después de la posmenopausia), que, si son sexualmente activas, aceptan utilizar uno de los métodos anticonceptivos médicamente aceptables, además del uso sistemático y correcto de un preservativo, desde la fecha de selección hasta 15 semanas después de la última administración de la medicación del estudio. Los métodos anticonceptivos médicamente aceptables son: anticonceptivos que contengan etinilestradiol, diafragma con sustancia espermicida y dispositivo intrauterino, o b. Mujeres quirúrgicamente esterilizadas con confirmación de histerectomía, ligadura de trompas u ooforectomía bilateral completa, o c. Mujeres posmenopáusicas, definiéndose la posmenopausia como el cese permanente hace ? 1 año de la menstruación previa, y d. Resultado negativo en la prueba de determinación de la subunidad ß de la gonadotropina coriónica humana (ß-HCG) en suero y en la prueba de embarazo en orina antes de la aleatorización.
Varones: a. Que se confirme que son estériles, o b. Que utilizan de manera constante y correcta un método anticonceptivo eficaz (p. ej., preservativos) durante el estudio y durante las 15 semanas posteriores a la última administración de la medicación del estudio.
3. Poder cumplir el calendario de visitas del estudio y otros requisitos del protocolo. |
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E.4 | Principal exclusion criteria |
- Patients who were not compliant with key study procedures (colonoscopy, treatment compliance, endpoint assessment, contraception measures) in preceding trial 1311.6 - Patients who could not tolerate BI 655066 treatment for tolerability or safety reasons in the preceding trial - Are pregnant, nursing, or planning pregnancy while enrolled in the study, or within 15 weeks after receiving the last dose of study medication. - Patients must agree not to receive a live virus or bacterial or Bacille Calmette-Guérin vaccination during the study or up to 12 months after the last administration of study drug. - Patients who have developed malignancy, or suspicion of active malignant disease during the preceding trial - Are intending to participate in any other study using an investigational agent or procedure during participation in this study. - Cannot adhere to the concomitant medication requirements |
1. Pacientes que no cumplieron los principales procedimientos del estudio (colonoscopia, cumplimiento terapéutico, evaluación de los criterios de valoración, medidas anticonceptivas) en el ensayo 1311.6. 2. Pacientes que no pudieron tolerar el tratamiento con BI 655066 por motivos de tolerabilidad o seguridad en el estudio anterior. 3. Mujeres embarazadas, en periodo de lactancia o que prevean quedarse embarazadas durante la participación en el estudio o en las 15 semanas siguientes a la administración de la última dosis de medicación del estudio. 4. Los pacientes deben aceptar no recibir vacunas elaboradas con virus vivos, bacterias o el BCG durante el estudio y hasta transcurridos 12 meses de la última administración de fármaco del estudio. 5. Pacientes que hayan presentado una neoplasia maligna o en los que se sospeche la presencia de una neoplasia maligna activa durante el estudio anterior. 6. Pacientes que tienen intención de participar en otro estudio con un fármaco o procedimiento en fase de investigación durante la participación en este estudio. 7. Pacientes que no pueden cumplir los requisitos de medicación concomitante |
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E.5 End points |
E.5.1 | Primary end point(s) |
1: Incidence of drug-related adverse events |
Incidencia de acontecimientos adversos relacionados con el fármaco |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1: 216 weeks |
1: 216 semanas |
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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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 36 |
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 |
Korea, Republic of |
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
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 10 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
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 | 10 |