E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
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 | 18.1 |
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 |
|
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 sarilumab in patients with
rheumatoid arthritis |
|
E.2.2 | Secondary objectives of the trial |
Assess the long term efficacy of sarilumb in patients with rheumatoid arthritis |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Title: A multi-center open-label sub-study of SARIL-RA-EXTEND to
explore the usability of the Sarilumab pre-filled syringe with safety
system (PFS-S) in patients with active rheumatoid arthritis [RA]
Protocol: version 1, 31 August 2015
Primary objective: To assess the usability of the sarilumab pre-filled
syringe with safety system (PFS-S) when administered to patients with
active rheumatoid arthritis (RA)
Secondary objective: To document the safety of sarilumab Dose 1 PFS-S
and sarilumab Dose 2 PFS-S |
|
E.3 | Principal inclusion criteria |
Patient with Rheumatoid Arthritis (RA) who were previously randomized in the sarilumab RA clinical program: e.g., the EFC11072 study, ACT11575 study, EFC10832 study, SFY13370 study; or EFC13752 study |
|
E.4 | Principal exclusion criteria |
Patient with any adverse event leading to permanent study drug discontinuation from a prior study.
Patients with an abnormality(ies) or adverse event(s) that per investigator judgment would adversely affect participation of the patient in the study |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Number of patients with adverse events |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At least 264 weeks or until commercial availability whichever later but
no later than 2020 |
|
E.5.2 | Secondary end point(s) |
1- Percentage of patients who achieve 20% improvement response according to the American College of Rheumatology criteria (ACR20)
2- Disease Activity Score (DAS28-CRP)
3- European League Against Rheumatism (EULAR) response |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1- Up to 264 weeks
2-3- At least 264 weeks or until commercial availability whichever
later but no later than 2020 |
|
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 | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 106 |
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 |
Austria |
Belarus |
Belgium |
Brazil |
Canada |
Chile |
Colombia |
Czech Republic |
Ecuador |
Estonia |
Finland |
Germany |
Greece |
Guatemala |
Hong Kong |
Hungary |
Israel |
Italy |
Korea, Republic of |
Lithuania |
Malaysia |
Mexico |
Netherlands |
New Zealand |
Peru |
Philippines |
Poland |
Portugal |
Romania |
Russian Federation |
South Africa |
Spain |
Sweden |
Taiwan |
Thailand |
Turkey |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 10 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial months | 6 |