A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA)
A Multi-center, Uncontrolled Extension Study Evaluating Efficacy and Safety of SAR153191 in Patients With Active Rheumatoid Arthritis (RA)
Main Study:
Primary Objective:
Assess the long term safety of sarilumab in participants with rheumatoid arthritis (RA).
Secondary Objective:
Assess the long term efficacy of sarilumab in participants with RA.
Sub-Study:
This phase 3, open label sub-study was aimed to assess the usability of PFS-S when used by participants with moderate or severe RA, or their professional or non-professional healthcare providers in an unsupervised real-world situation. To mimic the real-world practice, the sub-study was incorporated into the LTS11210 study without additional visits compared to the scheduled visits in the main study. The duration of this sub-study was 12 weeks.
The maximum duration of the study was up to 523 weeks:
Inclusion criteria :
Main study:
Participants with RA who were previously randomized in the sarilumab RA clinical program: e.g., the EFC11072 study, ACT11575 study, EFC10832 study, SFY13370, and EFC13752 study.
Sub-study:
Participants enrolled in the LTS11210 study who were receiving either sarilumab 200mg q2w PFS or sarilumab 150mg q2w PFS and who were able and willing to participate in this sub-study.
Participants who had been enrolled in the main study for at least 24 weeks. Participants must sign a sub-study written informed consent prior to any sub-study related procedure.
Exclusion criteria:
Main study:
Participants with any adverse event (AE) led to permanent study drug discontinuation from a prior study.
Participants with an abnormality(ies) or AEs that per investigator judgment would adversely affect participation of the participant in the study.
Sub-study: There are no additional exclusion criteria to those defined in main study.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Caba, C1015ABO, Argentina
Caba, C1055AAF, Argentina
Caba, C1428DZF, Argentina
Capital Federal, 1180, Argentina
Capital Federal, 1425, Argentina
Temuco IX Region, 4790928, Chile
Taoyuan County, 33305, Taiwan