E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate to Severe Rheumatoid Arthritis |
Artritis reumatoide de moderada a severa. |
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E.1.1.1 | Medical condition in easily understood language |
Moderate to Severe Rheumatoid Arthritis |
Artritis reumatoide de moderada a severa. |
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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 | 16.1 |
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 |
The primary objective is to evaluate the long-term safety and efficacy of ABP 501 in subjects with moderate to severe rheumatoid arthritis. |
Evaluar la eficacia y seguridad a largo plazo de ABP 501 en pacientes con artritis reumatoide (AR) moderada o severa |
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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 must sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved nformed consent form before any study specific procedures. 2. Subject was randomized into protocol 20120262 and has completed the week 26 visit. 3. Women with childbearing potential should have a negative urine pregnancy test prior to the first investigational product (IP) dose. |
1. El paciente debe firmar un documento de consentimiento informado aprobado por un Comité Ético de Investigación Clínica (CEIC) antes de que se realice cualquier procedimiento específico del estudio. 2. El paciente debe haber sido aleatorizado en el estudio 20120262 y haber completado la visita de la semana 26. 3. Las mujeres con capacidad de quedar embarazadas deben tener una prueba de embarazo en orina con resultado negativo antes de la administración de la primera dosis del producto en investigación (PI). |
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E.4 | Principal exclusion criteria |
1. Subject experienced a serious adverse event (SAE) or an adverse event (AE) in the 20120262 study that, in the opinion of the Investigator, could cause extension of treatment to be detrimental to the subject. 2. Subject is currently experiencing an infection requiring the use of oral or intravenous antibiotics. Subject is ineligible until the infection is resolved in the opinion of the Investigator. 3. Subject has completed study 20120262 but cannot be dosed within 4 weeks of the week 26 visit of study 20120262. 4. Subject has laboratory abnormalities during screening for this study 20130258, including: - Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT); > 2.0 x upper limit of normal - Hemoglobin < 9 g/dL - Platelet count < 100,000/mm3 - White blood cell count < 3,000 cells/mm3 - Estimated creatinine clearance < 50 mL/min (Cockroft-Gault formula) - Any other laboratory abnormality, which, in the opinion of the Investigator, will prevent the subject from completing the study or will interfere with the interpretation of the study results 5. Subject has developed significant concurrent medical condition during study 20120262, including: - Uncontrolled, clinically significant systemic disease such as diabetes mellitus, cardiovascular disease including moderate to severe heart failure (New York Heart Association [NYHA] class III/IV), renal disease, liver disease, or hypertension - Major chronic inflammatory disease or connective tissue disease other than RA (eg, systemic lupus erythematosus), with the exception of secondary Sjögren?s syndrome - Multiple sclerosis or any other demyelinating disease - Malignancy EXCEPT treated and considered cured cutaneous squamous or basal cell carcinoma, in situ cervical cancer, OR in situ breast ductal carcinoma - Any condition that, in the opinion of the Investigator, could cause this study to be detrimental to the subject 6. Subject will not be available for protocol-required study visits, to the best of the subject?s and Investigator?s knowledge 7. Subject is pregnant or breast feeding, or planning to become pregnant while enrolled in the study and 5 months after the last dose of IP 8. Sexually active subjects and their partners who are of childbearing potential (ie, neither surgically sterile nor postmenopausal) and not agreeing to use adequate contraception (eg, true abstinence, sterilization, birth control pills, Depo-Provera injections, or contraceptive implants) while on study and for 5 months after the last dose of study drug. Male subjects must agree not to donate sperm during the study and for 5 months following treatment with IP or until the scheduled end of the stud (whichever is longer) 9. Known sensitivity to mammalian cell-derived drug products or hypersensitivity to the active substance or to any of the excipients of ABP 501 10. Any physical or psychiatric disorder which, in the opinion of the Investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results 11. Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures 12. Active substance abuse, in the opinion of the Investigator 13. Any subject, who in the opinion of the Investigator, will not benefit from the long-term treatment in this study |
1. En el estudio 20120262 el paciente ha experimentado un contecimiento adverso grave (AAG) o un acontecimiento adverso (AA) que, a criterio del investigador, podría hacer que la extensión del tratamiento sea perjudicial para el paciente. 2. El paciente está experimentando actualmente una infección que requiere el uso de antibióticos orales o intravenosos. El paciente no es elegible hasta que la infección no se haya resuelto, a criterio del investigador. 3. El paciente ha completado el estudio 20120262 pero no puede ser tratado en el transcurso de las 4 semanas siguientes a la visita de la semana 26 del estudio 20120262. 4. El paciente presenta alteraciones analíticas durante la selección para este estudio 20130258, incluyendo: ? Elevación de aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT); > 2,0 x límite superior de normalidad ? Hemoglobina < 9 g/dl ? Recuento de plaquetas < 100.000 mm3 ? Recuento de leucocitos <3.000 células/mm3 ? Aclaramiento de creatinina estimado < 50 ml/min (fórmula de Cockroft-Gault) ? Cualquier otra alteración analítica que, a criterio del investigador, impedirá al paciente completar el estudio o interferirá con la interpretación de los resultados del estudio 5. El paciente ha desarrollado una afección médica concurrente significativa en el transcurso del estudio 20120262, incluyendo: ? Enfermedad sistémica clínicamente significativa no controlada como diabetes mellitus, enfermedad cardiovascular incluyendo insuficiencia cardiaca moderada o severa (clase III/IV de la Asociación del Corazón de Nueva York [NYHA]), enfermedad renal, enfermedad hepática o hipertensión ? Enfermedad inflamatoria crónica importante o enfermedad del tejido conectivo distinta de la AR (p. ej., lupus eritematoso sistémico), exceptuando el síndrome de Sjögren secundario ? Esclerosis múltiple o cualquier otra enfermedad desmielinizante ? Neoplasia maligna EXCEPTO carcinoma cutáneo basocelular o espinocelular, cáncer cervical in situ O carcinoma ductal de mama in situ, tratados y que se consideran curados. ? Cualquier afección que, a criterio del investigador, podría hacer que este estudio sea perjudicial para el paciente 6. El paciente no tendrá disponibilidad para efectuar las visitas que el protocolo requiere, según el leal saber y entender del paciente y del investigador 7. La paciente está embarazada o dando el pecho, o está considerando quedarse embarazada mientras está incluida en el estudio o en los 5 meses posteriores a la última dosis del PI 8. Pacientes sexualmente activos con parejas con capacidad de quedar embarazadas (es decir, que no sean quirúrgicamente estériles ni postmenopáusicas) que no accedan a utilizar métodos anticonceptivos adecuados (p. ej., abstinencia verdadera, esterilización, píldoras anticonceptivas, inyecciones de Depo-Provera o implantes anticonceptivos) mientras estén participando en el estudio y durante los 5 meses siguientes a la última dosis del fármaco del estudio. Los pacientes varones deben acceder a no donar esperma en el transcurso del estudio y durante los 5 meses posteriores al tratamiento con el PI o hasta la finalización programada del estudio (el periodo que sea más prolongado) 9. Sensibilidad conocida a productos farmacéuticos derivados de células de mamíferos o hipersensibilidad al principio activo o a cualquiera de los excipientes de ABP 501 10. Cualquier trastorno físico o psiquiátrico que, a criterio del investigador, impedirá al paciente completar el estudio o interferirá con la interpretación de los resultados del estudio 11. Cualquier trastorno que comprometa la capacidad del paciente de dar su consentimiento informado por escrito y/o de cumplir los procedimientos del estudio 12. Abuso activo de sustancias, a criterio del investigador 13. Cualquier paciente que, a criterio del investigador, no vaya a beneficiarse del tratamiento a largo plazo en este estudio |
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E.5 End points |
E.5.1 | Primary end point(s) |
Safety Endpoints: - treatment-emergent adverse events and SAEs - clinically significant changes in laboratory analytes - antidrug antibody incidence |
Criterios de valoración de seguridad: ? acontecimientos adversos surgidos durante el tratamiento y AAG ? cambios clínicamente relevantes en analitos de laboratorio ? incidencia de anticuerpos anti-fármaco |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
During entire duration of the study. |
A lo largo de todo el estudio. |
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E.5.2 | Secondary end point(s) |
Efficacy Endpoints: - Disease Activity Score (DAS)28 and ACR20 (20% improvement in American College of Rheumatology [ACR] core set measurements) at all measured time points |
Criterios de valoración de eficacia: ? Índice de actividad de la enfermedad (DAS)28 y respuesta ACR20 (mejoría del 20% en las medidas del grupo principal de respuesta del Colegio Americano de Reumatología [ACR]) en todas las visitas en las que se evalúen |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
ACR20 and DAS28 will be summarized descriptively during the study. Evaluations to be performed at weeks 4, 24, 48 and 70. |
La respuesta ACR20 (mejoría del 20% en las medidas del grupo principal de respuesta del Colegio Americano de Reumatología [ACR]) y el índice de actividad de la enfermedad (DAS)28 serán evaluados de forma descriptiva durante el estudio. |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
ADA - anti-drug antibody testing is being performed |
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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 | 70 |
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 |
Bulgaria |
Canada |
Romania |
Argentina |
Czech Republic |
Germany |
Hungary |
Spain |
Mexico |
Poland |
Russian Federation |
United Kingdom |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |