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 |
|
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 | 14.0 |
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 |
|
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 |
Composite of major adverse cardiovascular events (MACE) consisting of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke of all classifications. |
Combinación de acontecimientos cardiovasculares adversos graves (ACAG) consistentes en fallecimiento de origen cardiovascular, infarto de miocardio no mortal y accidente cerebrovascular no mortal de todo tipo. |
|
E.2.2 | Secondary objectives of the trial |
Composite endpoint of major cardiovascular events, non-elective coronary revascularization procedures and hospitalization for unstable angina |
Combinación cardiovascular del primer criterio de valoración con la adición de procedimientos de revascularización coronaria no selectivos y hospitalización por angina de pecho inestable. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adult patients, >/=50 years of age - Patients with moderate to severe rheumatoid arthritis >/=6 months duration - Inadequate response to at least one non-biologic disease-modifying antirheumatic drug (DMARD) - Presence of one or more additional Coronary Heart Disease (CHD) risk factors, including current cigarette smoking, hypertension, low HDL cholesterol, family history of premature CHD, diabetes, presence of extra-articular disease associated with rheumatoid arthritis |
- Hombres y mujeres, de 50 años. - Pacientes con AR de duración > 6 meses en el momento de la visita inicial. - Respuesta inadecuada a, al menos, un FARME no biológico. - Presencia de uno o más factores de riesgo de enfermedad de las arterias coronarias (EAC), que incluyen tabaquismo (en la actualidad), hipertensión, colesterol HDL bajo, antecedentes familiares de EAC precoz, diabetes, presencia de enfermedad extraarticular asociada a la AR. |
|
E.4 | Principal exclusion criteria |
- Major surgery within 8 weeks prior to screening or planned major surgery within 1 year of study start - Rheumatic autoimmune disease other than rheumatoid arthritis - History or current inflammatory joint disease other than rheumatoid arthritis - Current or recent (within past 3 months) evidence of serious uncontrolled concomitant cardiovascular or cerebrovascular disease (Myocardial infarction, revascularization, stroke, transient ischaemic attack, or acute coronary syndrome) |
- Cirugía mayor en las 8 semanas anteriores a la selección o cirugía mayor planificada en el plazo de un año antes del inicio. - Enfermedad reumática autoinmune distinta de la AR. - Antecedentes o presencia de enfermedad inflamatoria de las articulaciones distinta de la AR. - Evidencia actual o reciente (en los últimos 3 meses) de enfermedad cerebrovascular o cardiovascular concomitante grave sin controlar (IM, revascularización, accidente cerebrovascular isquémico, ataque isquémico transitorio o síndrome coronario agudo). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is defined as the time to first cardiovascular event, cardiovasular death, myocardial infarction or stroke. |
El criterio de valoración principal se define como el tiempo transcurrido hasta el primer acontecimiento adjudicado por CV-EAC. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Monthly assessments for CV events with the onset date of the event based on the clinical presentation. |
Evaluaciones mensuales de acontecimientos CV con la fecha de inicio del acontecimiento basado en la aparición clínica. |
|
E.5.2 | Secondary end point(s) |
The time to first occurrence of an expanded composite endpoint, defined as the primary endpoint with the addition of nonelective coronary revascularization procedures and hospitalization for unstable angina. |
El tiempo hasta la aparición del primer criterio de valoración combinado ampliado, definido como el criterio de valoración principal con la adición de procedimientos de revascularización coronaria no selectivos y hospitalización por angina de pecho inestable. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Monthly assessments for CV events with the onset date of the event based on the clinical presentation. |
Evaluaciones mensuales de acontecimientos CV con la fecha de inicio del acontecimiento basado en la aparición clínica. |
|
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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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) | Yes |
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 | 12 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 99 |
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 |
Austria |
Belgium |
Bosnia and Herzegovina |
Brazil |
Canada |
Chile |
China |
Croatia |
Czech Republic |
Denmark |
Ecuador |
France |
Germany |
Greece |
Hungary |
India |
Israel |
Italy |
Latvia |
Lithuania |
Malaysia |
Mexico |
Netherlands |
Philippines |
Poland |
Romania |
Russian Federation |
Serbia |
South Africa |
Spain |
Turkey |
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
|
See protocol section 3.1.2. |
Ver protocolo sección 3.1.2. |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |