Sarilumab SAR153191 (REGN88) ( DrugBank: Sarilumab, REGN88, SAR153191 )

2 diseases
告示番号疾患名（ページ内リンク）臨床試験数
46悪性関節リウマチ7
107若年性特発性関節炎1

46. 悪性関節リウマチ

臨床試験数 : 4,356 /  薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT03378219
(ClinicalTrials.gov)		May 18, 201815/12/2017An Observational Study on Sarilumab-exposed PregnanciesKevzara® (Sarilumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance StudyRheumatoid Arthritis -Exposure During PregnancyDrug: Sarilumab SAR153191 (REGN88)SanofiRegeneron PharmaceuticalsActive, not recruitingN/AN/AFemale113United States;Canada
2NCT02404558
(ClinicalTrials.gov)		May 201526/3/2015Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid ArthritisAn Open-label, Randomized, Parallel Group, Single-dose Study to Describe the Safety of IL-6 Receptor Blockade With Sarilumab or Tocilizumab Monotherapy in Japanese Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: sarilumab SAR153191 (REGN88);Drug: tocilizumabSanofiRegeneron PharmaceuticalsCompleted20 YearsN/ABoth30Phase 1Japan
3NCT02293902
(ClinicalTrials.gov)		November 201413/11/2014A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)A Randomized, Double-blind, Multicenter Study With a Placebo-controlled Period Assessing the Efficacy and Safety of Sarilumab Added to Methotrexate (MTX) in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis Who Are Inadequate Responders to MTX TherapyRheumatoid ArthritisDrug: Sarilumab SAR153191 (REGN88);Other: Placebo (for sarilumab);Drug: Methotrexate;Drug: Folic acidSanofiRegeneron PharmaceuticalsCompleted20 Years75 YearsAll243Phase 3Japan
4NCT02121210
(ClinicalTrials.gov)		June 201421/4/2014To Evaluate the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Rheumatoid Arthritis (RA)An Open-label, Randomized, Parallel Group Study Assessing the Immunogenicity and Safety of Sarilumab Administered as Monotherapy in Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: sarilumab SAR153191 (REGN88)SanofiRegeneron PharmaceuticalsCompleted18 YearsN/AAll132Phase 3United States;Chile;Czechia;Estonia;Hungary;Poland;Russian Federation;Czech Republic
5NCT02017639
(ClinicalTrials.gov)		January 20142/12/2013Sarilumab Effect on the Pharmacokinetics of SimvastatinA Multi-center, Open-label, 2-treatment, Single-sequence Clinical Study to Evaluate the Effects of a Single 200 mg Subcutaneous Injection of Sarilumab on the Pharmacokinetics of a Single 40 mg Oral Dose of Simvastatin, With Optional 1-year Extension of Open Label Treatment of Sarilumab, in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: sarilumab SAR153191 (REGN88);Drug: simvastatinSanofiRegeneron PharmaceuticalsCompleted18 Years75 YearsBoth19Phase 1United States;Korea, Republic of;Moldova, Republic of
6NCT01850680
(ClinicalTrials.gov)		April 20131/5/2013Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered Sarilumab in Japanese Patients With Rheumatoid Arthritis Receiving Concomitant MethotrexateRheumatoid ArthritisDrug: sarilumab SAR153191 (REGN88);Drug: placebo;Drug: methotrexate;Drug: folic acidSanofiRegeneron PharmaceuticalsCompleted20 Years65 YearsBoth61Phase 1Japan
7NCT01768572
(ClinicalTrials.gov)		March 201311/1/2013To 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)A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF AntagonistsRheumatoid ArthritisDrug: sarilumab SAR153191 (REGN88);Drug: tocilizumab;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide;Drug: subcutaneous placebo;Drug: intravenous placeboSanofiRegeneron PharmaceuticalsCompleted18 YearsN/AAll202Phase 3United States;Argentina;Belgium;Brazil;Czechia;Estonia;Finland;Hungary;Israel;Italy;Mexico;Netherlands;Norway;Poland;Romania;Russian Federation;Spain;Sweden;United Kingdom;Czech Republic

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107. 若年性特発性関節炎

臨床試験数 : 447 /  薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT02991469
(ClinicalTrials.gov)		August 9, 201814/10/2016A Repeated Dose-finding Study of Sarilumab in Children and Adolescents With Systemic Juvenile Idiopathic Arthritis (SKYPS)An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered With Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, With Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension PhaseJuvenile Idiopathic ArthritisDrug: Sarilumab SAR153191 (REGN88)SanofiRegeneron PharmaceuticalsRecruiting1 Year17 YearsAll72Phase 2Argentina;Bulgaria;Canada;Czechia;Finland;France;Germany;Ireland;Italy;Russian Federation;Spain;United Kingdom;Chile;Estonia;Netherlands;Poland;United States

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