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sarilumab SAR153191 (REGN88)

DRUG9 trials

Sponsors

Sanofi

Conditions

Juvenile Idiopathic ArthritisPolymyalgia RheumaticaRheumatoid ArthritisRheumatoid Arthritis -Exposure During Pregnancy

Phase 1

Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis
CompletedNCT01850680
SanofiRheumatoid Arthritis
Start: 2013-04-30End: 2013-12-31Updated: 2014-01-28
Sarilumab Effect on the Pharmacokinetics of Simvastatin
CompletedNCT02017639
SanofiRheumatoid Arthritis
Start: 2014-01-31End: 2016-03-31Updated: 2016-04-07
Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis
CompletedNCT02404558
SanofiRheumatoid Arthritis
Start: 2015-05-31End: 2016-03-31Updated: 2016-03-28

Phase 2

A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)
RecruitingNCT02991469
SanofiJuvenile Idiopathic Arthritis
Start: 2018-08-09End: 2029-02-19Target: 51Updated: 2026-03-11

Phase 3

To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)
CompletedNCT01768572
SanofiRheumatoid Arthritis
Start: 2013-03-31End: 2014-10-31Updated: 2017-06-26
To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)
CompletedNCT02121210
SanofiRheumatoid Arthritis
Start: 2014-06-30End: 2015-05-31Updated: 2017-06-20
A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)
CompletedNCT02293902
SanofiRheumatoid Arthritis
Start: 2014-11-30End: 2016-10-31Updated: 2018-01-30
Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica
TerminatedNCT03600818
SanofiPolymyalgia Rheumatica
Start: 2018-10-09End: 2021-05-19Updated: 2022-06-10

Unknown Phase

An Observational Study on Sarilumab-exposed Pregnancies
CompletedNCT03378219
SanofiRheumatoid Arthritis -Exposure During Pregnancy
Start: 2018-05-18End: 2024-12-06Updated: 2025-01-17

Related Papers

Sarilumab in relapsing polymyalgia rheumatica: patient-reported outcomes from a phase 3, double-blind, randomised controlled trial.
2025-06-195 citations
Population Pharmacokinetics and Exposure‐Response Analyses of Sarilumab in Patients with Polymyalgia Rheumatica
The Journal of Clinical Pharmacology2025-03-19
Efficacy and safety of sarilumab in patients with rheumatoid arthritis stratified by age (&amp;lt;65 and ≥65 years): A <i>post hoc</i> analysis of Japanese Phase 3 clinical trials
Modern Rheumatology2024-07-282 citations
Sarilumab for Relapse of Polymyalgia Rheumatica during Glucocorticoid Taper
New England Journal of Medicine2023-10-0489 citations
Long-term safety and efficacy of sarilumab with or without background csDMARDs in rheumatoid arthritis
Lara D. Veeken2023-02-0211 citations
Disproportionate articular pain is a frequent phenomenon in rheumatoid arthritis and responds to treatment with sarilumab
Lara D. Veeken2022-11-2117 citations
Haemoglobin changes and disease activity in Japanese patients with rheumatoid arthritis treated with sarilumab.
2022-10-281 citations
Sarilumab for polymyalgia rheumatica led to sustained remission and fewer flares
2022-07-21
Pharmacokinetics, pharmacodynamics, and safety of single-dose subcutaneous sarilumab with or without methotrexate in Japanese patients with rheumatoid arthritis: Two single-dose studies
Modern Rheumatology2022-04-21
Identification of a Rule to Predict Response to Sarilumab in Patients with Rheumatoid Arthritis Using Machine Learning and Clinical Trial Data
Rheumatology and Therapy2021-09-1423 citations
Subcutaneous Sarilumab in Patients With Rheumatoid Arthritis who Previously Received Subcutaneous Sarilumab or Intravenous Tocilizumab: An Open‐Label Extension of a Randomized Clinical Trial
ACR Open Rheumatology2020-11-0119 citations
Population Pharmacokinetic-Pharmacodynamic Relationships of Sarilumab Using Disease Activity Score 28-Joint C-Reactive Protein and Absolute Neutrophil Counts in Patients with Rheumatoid Arthritis.
2020-11-014 citations
Population Pharmacodynamic Model of Neutrophil Margination and Tolerance to Describe Effect of Sarilumab on Absolute Neutrophil Count in Patients with Rheumatoid Arthritis
CPT Pharmacometrics & Systems Pharmacology2020-05-269 citations
Immunogenicity of Sarilumab Monotherapy in Patients with Rheumatoid Arthritis Who Were Inadequate Responders or Intolerant to Disease-Modifying Antirheumatic Drugs.
2019-05-1424 citations
Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a randomized, placebo-controlled phase III trial in Japan.
2019-03-2017 citations
Safety and tolerability of subcutaneous sarilumab and intravenous tocilizumab in patients with rheumatoid arthritis
Lara D. Veeken2018-11-22123 citations
Disease-Drug Interaction of Sarilumab and Simvastatin in Patients with Rheumatoid Arthritis.
2017-06-0159 citations