E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rheumatoid Arthritis |
artrite reumatoide |
|
E.1.1.1 | Medical condition in easily understood language |
Rheumatoid Arthritis |
Artrite 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 |
Assess the long term safety of SAR153191 on top of Disease Modifying Anti-Rheumatic Drugs (DMARDs) in patients with rheumatoid arthritis |
Valutazione della sicurezza a lungo termine di SAR153191 somministrato in associazione a un farmaco antireumatico che modifica il decorso della malattia (DMARD) in pazienti con Artrite Reumatoide (RA). |
|
E.2.2 | Secondary objectives of the trial |
Assess the long term efficacy of SAR153191 on top of DMARDs in patients with rheumatoid arthritis |
valutazione dell'efficacia a lungo termine di SAR153191 in associazione a un farmaco antireumatico che modifica il decorso della malattia (DMARD) in pazienti con Artrite Reumatoide (RA). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient with Rheumatoid Arthritis (RA) who was previously randomized in the EFC11072 study (MOBILITY): - Randomized in Part A (dose selection part) and who have completed the12-week treatment period, - Or randomized in Part B (confirmatory part) and who have completed the 52-week treatment period - Or randomized in Part B prior to dose selection then discontinued because non-selected dose regimen. Or Patient with Rheumatoid Arthritis (RA) who was previously randomized in the ACT11575 study and who have completed the 12-week treatment period. |
- Pazienti con RA che sono stati randomizzati nello studio (non in corso in Italia) EFC11072 MOBILITY - e che hanno completato la parte A (12 settimane) o la parte B (52 settimane) dello studio EFC11072. - oppure pazienti randomizzati nella parte B (coorte 1) dello studio EFC11072 a un braccio di trattamento non scelto dopo la selezione della dose nella fase pivotal - Pazienti con RA che sono stati randomizzati nello studio ACT11575 (in corso in Italia) e che hanno completato il periodo di trattamento dello studio di 12 settimane |
|
E.4 | Principal exclusion criteria |
Adverse event(s) having lead to treatment discontinuation in the previous study (EFC11072 or ACT11575). Event or laboratory abnormality observed at the last treatment visit of the previous study (EFC11072 or ACT11575) that would adversely affect participation of the patient in this study as per investigator judgment |
Pazienti che hanno avuto un qualunque evento avverso che ha causato l’interruzione del farmaco in studio (attivo o placebo) nell’ambito dello studio EFC11072 o ACT11575 - Pazienti che hanno avuto un qualsiasi evento o alterazione degli esami di laboratorio allo screening (corrispondente alla visita di fine trattamento nell’ambito dello studio EFC11072 o ACT11575) che a parere dello sperimentatore potrebbe compromettere la partecipazione del paziente in questo studio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Number of patients with adverse events |
Numero di pazienti con eventi avversi |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to a maximum of 266 weeks |
fino ad un massimo di 266 settimane |
|
E.5.2 | Secondary end point(s) |
Percentage of patients who achieve 20% improvement response according to the American College of Rheumatology criteria (ACR20) - Disease Activity Score (DAS28) - European League Against Rheumatism (EULAR) response |
Percentuale di pazienti che hanno raggiunto un miglioramento del 20% dell’indice di attività di malattia ACR (ACR20), che hanno avuto risposta in base ai criteri del Disease Activity Score 28 (DAS 28), e dell’European League Against Rheumatism (Eular) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
up to a maximum of 260 weeks |
fino ad un massimo di 260 settimane |
|
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 | 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) | 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 | 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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 94 |
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 |
Brazil |
Canada |
Chile |
Colombia |
Egypt |
India |
Korea, Democratic People's Republic of |
Malaysia |
Mexico |
New Zealand |
Peru |
Philippines |
Russian Federation |
South Africa |
Taiwan |
Thailand |
Ukraine |
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
|
LVLS taking into account treatment up to 5 years from the first study drug intake or until commercially available or until discontinuation of the project whichever sooner |
LVLS tenendo conto di un periodo massimo di 5 anni a partire dalla data della prima assunzione, oppure fino alla sua commercializzazione o fino all’interruzione dello studio, qualunque delle condizioni si verifichi prima. |
|
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 | 11 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 14 |
E.8.9.2 | In all countries concerned by the trial days | 0 |