Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
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).
Full description
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).
Enrollment
Sex
Ages
Volunteers
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.
Primary purpose
Allocation
Interventional model
Masking
217 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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