At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 132 enrolled
Drug / intervention
sarilumab SAR153191 (REGN88)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Randomized, Parallel Group Study Assessing the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Active Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating sarilumab SAR153191 (REGN88) for Rheumatoid Arthritis. Completed, enrolled 132 participants across 28 sites in 7 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesChile, Czechia, Estonia, Hungary, Poland, Russia, United States
CollaboratorsRegeneron Pharmaceuticals
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 2014
Enrollment StartJun 2014
Primary CompletionMay 2015
TodayJul 2026
First PostedApr 23, 2014
Enrollment StartJun 1, 2014
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.2 years ago
Interventions
sarilumab SAR153191 (REGN88)drug
Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous