Primary Objective: To collect real-use data of the sarilumab auto-injector device (AID) used by rheumatoid arthritis (RA) participants. Secondary Objective: To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus prefilled syringes (PFS).
Total study duration up to 74 weeks: screening up to 4 weeks, AID assessment phase of 12 weeks, extension phase of 52 weeks and post-treatment follow-up of 6 weeks. For participants not entering the extension phase, total study duration up to 22 weeks (screening, AID assessment phase and follow-up).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
217
Pharmaceutical form: Solution Route of administration: Subcutaneous
Number of Validated AID Associated Product Technical Failures (PTFs)
A PTF was defined as any product technical complaint (PTC) related to the use of the AID that had a validated technical cause. Each participant was given a diary having questions related to participant's ability to remove the cap, to start the injection, to complete the injection and regarding confirmation of completing the injection. Participants were asked to answer the questions each time they self-inject the sarilumab. If the response was "no" to any of the first 3 questions, this was considered as a PTC. The used AID, for which PTC was reported, was sent to sponsor, examined and evaluated for the occurrence of a PTF.
Time frame: Baseline up to Week 12
Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab
AUC(0-tau) is defined as area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval, where dose interval was 2 weeks. Serum concentrations of sarilumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Time frame: Week 0-2: pre-dose on Day 1, anytime post-dose on Day 3, Day 5, Day 8, Day 12, Day 15; Week 10-12: pre-dose on Day 71, anytime post-dose on Day 73, Day 75, Day 78, Day 82, Day 85
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Dispensed according to local practice.
Dispensed according to local practice.
Dispensed according to local practice.
Dispensed according to local practice.
Investigational Site Number 840152
Huntsville, Alabama, United States
Investigational Site Number 840221
Peoria, Arizona, United States
Investigational Site Number 840226
Roseville, California, United States
Investigational Site Number 840223
Boulder, Colorado, United States
Investigational Site Number 840229
Miami, Florida, United States
Investigational Site Number 840236
Orlando, Florida, United States
Investigational Site Number 840155
Palm Harbor, Florida, United States
Investigational Site Number 840220
South Miami, Florida, United States
Investigational Site Number 840202
Hagerstown, Maryland, United States
Investigational Site Number 840232
Flint, Michigan, United States
...and 43 more locations