Phase 3
Completed N=217
To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis
RA
Source: ClinicalTrials.gov NCT02057250 ↗
Enrolled (actual)
217
Serious AEs
6.7%
Results posted
Jun 2017
Primary outcomePrimary: Number of Validated AID Associated Product Technical Failures (PTFs) — 0; 0 PTFs
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Validated AID Associated Product Technical Failures (PTFs) |
0; 0 | — |
| SECONDARY Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab |
131; 152; 235; 227; 205; 220 | — |
Eligibility Criteria
Inclusion criteria
- Diagnosis of RA, ≥3 months disease duration;
- Participant willing and able to self-inject;
- Continuous treatment with 1 or a combination of non-biologic disease modifying antirheumatic drugs (DMARDs) (except leflunomide in combination with methotrexate);
- Moderate-to-severely active RA.
Exclusion criteria
- Participants <18 years;
- Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonists;
- Treatment with tumor necrosis factor (TNF) antagonists;
- Treatment with RA-directed biologic agents other than with a TNF-α antagonist mechanism as follows: Anakinra, Abatacept, Rituximab or other cell-depleting agent;
- Prior treatment with a Janus kinase inhibitor.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT02057250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.