Sarilumab
DrugPharmaceutical form: Solution Route of administration: Subcutaneous
Other names: SAR153191, REGN88
NCT Number: NCT02057250
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).
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Investigational Site Number 152005, Osorno, Chile
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Pharmaceutical form: Solution Route of administration: Subcutaneous
Other names: SAR153191, REGN88
Dispensed according to local practice.
Dispensed according to local practice.
Dispensed according to local practice.
Dispensed according to local practice.
Time frame: Baseline up to Week 12
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: 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
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).
Sanofi
Industry
A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy
Acronym: SARIL-RA-EASY
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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