Primary Objective: To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.
Total study duration was up to 34 weeks: Screening up to 28 days, treatment phase of 24 weeks, and post-treatment follow-up of 6 weeks. After completion of the treatment phase of this study, participants were eligible to enter a long term safety study (LTS11210) for active treatment with SAR153191 (REGN88).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
202
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: solution Route of administration: intravenous
Dispensed according to local practice.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. All adverse events that occurred from the first dose of the study drug administration up to 60 days after the end of treatment visit were considered as TEAEs. Serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. A summary of SAEs, all other non-serious AEs, regardless of causality, are reported in AE section.
Time frame: Up to 211 days
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Dispensed according to local practice.
Dispensed according to local practice.
Dispensed according to local practice.
Pharmaceutical form: solution Route of administration: subcutaneous
Pharmaceutical form: solution Route of administration: intravenous
Investigational Site Number 840152
Huntsville, Alabama, United States
Investigational Site Number 840151
Colorado Springs, Colorado, United States
Investigational Site Number 840153
Aventura, Florida, United States
Investigational Site Number 840033
Fort Lauderdale, Florida, United States
Investigational Site Number 840048
Miami, Florida, United States
Investigational Site Number 840155
Palm Harbor, Florida, United States
Investigational Site Number 840013
Wheaton, Maryland, United States
Investigational Site Number 840154
Boston, Massachusetts, United States
Investigational Site Number 840150
Lansing, Michigan, United States
Investigational Site Number 840062
Reading, Pennsylvania, United States
...and 68 more locations