E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rheumatoid arthritis |
Artritis Reumatoide |
|
E.1.1.1 | Medical condition in easily understood language |
Rheumatoid arthritis |
Artritis Reumatoide |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039073 |
E.1.2 | Term | Rheumatoid arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue 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 tolerability of filgotinib in subjects who have completed one of the parent studies of filgotinib in RA. |
- Evaluar la seguridad y tolerabilidad a largo plazo de filgotinib en pacientes que han completado uno de los estudios originales de filgotinib en AR. |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the long-term efficacy of filgotinib in subjects with RA - To evaluate the long-term effects of filgotinib on subject-reported outcomes, such as disability, fatigue, and quality of life. |
- Evaluar la eficacia a largo plazo de filgotinib en pacientes con AR. - Evaluar los efectos a largo plazo de filgotinib en los resultados percibidos por el paciente, como la discapacidad, fatiga y calidad de vida. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
2) Male or female subjects who may benefit from filgotinib as judged by the investigator AND who completed a Gilead sponsored filgotinib parent study for RA as outlined below: a) Subjects who completed GS-US-417-0301, GS-US-417-0302, or GS-US-417-0303 on study drug OR b) Subjects who completed GS-US-417-0302 on standard of care therapy due to RA non-responder status
3) Females of childbearing potential must have a negative pregnancy test prior to first dose of study drug in the LTE;
4) Lactating female subjects must agree to discontinue nursing at Day -1 for the duration of the study
5)Male and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception, during the study and through 35 days (female) or 90 days (male) after their last dose of study drug or longer as indicated by the product label of the subject's concurrent csDMARD therapy.
6)Subjects receiving protocol permitted RA medications should be on a stable dose (defined as no change in prescription) within 7 days or 5 half lives (whichever is longer) prior to the first administration of study drug on Day 1.
7) Subjects, who meet study drug interruption criteria at Day 1, are eligible to enter into the LTE, but should not start study drug until deemed medically appropriate. |
2) Hombres o mujeres que podrían beneficiarse con filgotinib, según el criterio del investigador, Y que han completado un estudio original de filgotinib promovido por Gilead para la AR, tal como se describe a continuación: a) Pacientes que han completado los estudios GS-US-417-0301, GS-US-417-0302, GS-US-417-0303 o recibiendo el fármaco del estudio O b) Pacientes que han completado el estudio GS-US-417-0302 recibiendo el tratamiento estándar debido a su estado de AR sin respuesta
3) Las mujeres con capacidad de concebir deben presentar un resultado negativo en la prueba de embarazo antes de la primera dosis de fármaco del estudio en la ELP;
4) Las mujeres en periodo de lactancia deben acceder a interrumpir la lactancia materna el día -1 y durante todo el periodo del estudio.
5) Los pacientes de sexo masculino y las de sexo femenino con capacidad de concebir que mantengan relaciones sexuales heterosexuales deben aceptar el uso de métodos anticonceptivos especificados en el protocolo, durante el estudio y hasta 35 días(mujeres) o 90 días (hombres) después de su última dosis del fármaco del estudio como se indica en la etiqueta del producto de la terapia del sujeto concomitante csDMARD.
6) Los pacientes que reciban medicación para la AR, permitidos en el protocolo, deben estar en una dosis estable (definida como sin cambio en la prescripción) dentro de los 7 días o 5 vidas medias (el período más extenso) antes de la primera administración de la medicación en el Día 1
7) Los pacientes que cumplen con el criterio de interrupción del medicamento en el Día 1, son elegibles para ingresar al ELP, pero no deben comenzar con el tratamiento hasta que la medicación se considere aprobada |
|
E.4 | Principal exclusion criteria |
1) Diagnosis of an autoimmune or inflammatory joint disease other than RA, which would put the subject at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator
2) Known hypersensitivity to the study drug or its excipients.
3) Any medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) which would put the subject at risk by participating in the study or would interfere with study assessments/data interpretation, per judgment of the investigator.
4) History of an infected joint prosthesis or other implanted device with retention of the prosthesis or device in situ.
5) Administration of a live/ attenuated vaccine within 30 days prior to Day 1
6) Currently on any therapy for chronic infection (such as pneumocystis, cytomegalovirus, herpes zoster, and atypical mycobacteria)
7) History of disseminated/complicated herpes zoster infection (multi dermatomal involvement, ophthalmic zoster, central nervous system involvement or postherpetic neuralgia)
8) Any condition or circumstances which in the opinion of the investigator or Sponsor may make a subject unlikely or unable to complete the study or comply with study procedures and requirements
9) Use of prohibited medication as outlined in the protocol
10) Subjects who meet discontinuation criteria as outlined in outlined in the protocol |
1) Diagnóstico de una enfermedad autoinmune o inflamatoria articular distinta a la AR, que pondría al paciente en riesgo debido a su participación en el estudio o que interferiría en las evaluaciones del estudio o la interpretación de datos, según el criterio del investigador.
2) Hipersensibilidad conocida al fármaco del estudio o a sus excipientes.
3) Cualquier afección médica (entre otras, enfermedad cardíaca o pulmonar, abuso de alcohol o drogas) que pondría al paciente en riesgo debido a su participación en el estudio o que interferiría en las evaluaciones del estudio o la interpretación de datos, según el criterio del investigador.
4) Historia de una prótesis articular infectada u otro dispositivo implantado con retención de la prótesis o dispositivo in situ.
5) La administración de una vacuna viva / atenuada dentro de los 30 días previos al Día 1
6) Actualmente en cualquier terapia para la infección crónica (como pneumocystis, cytomegalovirus, herpes zoster y micobacterias atípicas)
7) Historia de la infección de herpes zóster diseminada / complicada (compromiso multi-dermatomal, zoster oftálmico, afectación del sistema nervioso central o neuralgia postherpética)
8) Cualquier condición o circunstancias que en la opinión del investigador o Promotor puedan hacer que un paciente sea poco probable o no pueda completar el estudio o cumplir con los procedimientos y requisitos del estudio
9) El uso de medicamentos prohibidos como se indica en el protocolo
10) Los pacientes que cumplan con los criterios de discontinuidad descritos en el protocolo |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety, evaluated through AEs, clinical laboratory tests, and vital signs. |
Seguridad evaluada mediante los AAs, pruebas analíticas y constantes vitales. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
ACR-N responses in each arm. |
Respuestas ACR-N en cada grupo. |
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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 | 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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
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 | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 144 |
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 |
Belgium |
Brazil |
Bulgaria |
Canada |
Chile |
Colombia |
Czech Republic |
France |
Georgia |
Germany |
Hong Kong |
Hungary |
India |
Ireland |
Israel |
Italy |
Japan |
Korea, Republic of |
Malaysia |
Mexico |
Moldova, Republic of |
Netherlands |
New Zealand |
Peru |
Poland |
Romania |
Russian Federation |
Serbia |
Slovakia |
South Africa |
Spain |
Switzerland |
Taiwan |
Thailand |
Ukraine |
United Kingdom |
United States |
|
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
|
End of Study is defined as when the last subject has completed their last study visit or until study closure, eg, for the reasons indicated in protocol Section 3.4. |
El final del estudio se define como el momento en que el último paciente ha completado su última visita del estudio o hasta la conclusión del estudio, p. ej., por alguno de los motivos indicados en la sección 3.4 del protocolo. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 7 |