Primary Objective: To evaluate the immunogenicity of sarilumab administered as monotherapy. Secondary Objectives: * To evaluate the other safety aspects of sarilumab administered as monotherapy. * To assess the exposure of sarilumab administered as monotherapy.
Total study duration was up to 34 weeks: Up to 4-week screening period, 24-week open-label treatment phase, 6-week post-treatment observation. After completion of the treatment phase of this study, participants were eligible to enter a long term safety study (LTS11210 - SARIL-RA-EXTEND) for continuous treatment with sarilumab (SAR153191 \[REGN88\]).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
Percentage of Participants With Incidence of Antidrug Antibodies (ADA)
ADA to sarilumab and anti-sarilumab neutralizing antibodies in serum samples were determined using a validated electrochemiluminescence immunoassay method. Percentage of participants with positive ADA during treatment emergent adverse event (TEAE) period (time from first dose of investigational medicinal product \[IMP\] to last dose of IMP + 60 days) was determined. Persistent ADA Response: treatment-emergent ADA detected at 2 or more consecutive sampling time points during the TEAE period, where the first and last ADA positive samples were separated by a period of at least 16 weeks or if the last measured sample was positive. ADA samples were collected prior to IMP administration at Week 0 (baseline), Week 2, 4, 12, 24 and 30.
Time frame: From Baseline to Week 30 [End of study (EOS)]
Serum Sarilumab Concentration
Trough Concentration (Ctrough).
Time frame: Pre-dose at Week 0 (Baseline), 2, 4, 12, 16, 20, 24 and 30
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Investigational Site Number 840072
Gilbert, Arizona, United States
Investigational Site Number 840049
Upland, California, United States
Investigational Site Number 840220
South Miami, Florida, United States
Investigational Site Number 840230
Elizabethtown, Kentucky, United States
Investigational Site Number 840233
Minot, North Dakota, United States
Investigational Site Number 840127
Oklahoma City, Oklahoma, United States
Investigational Site Number 840011
Tulsa, Oklahoma, United States
Investigational Site Number 840009
Duncansville, Pennsylvania, United States
Investigational Site Number 840025
Jackson, Tennessee, United States
Investigational Site Number 840032
Amarillo, Texas, United States
...and 18 more locations