Sarilumab sar153191 (regn88) (DrugBank: Sarilumab, REGN88, SAR153191)
2 diseases| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 46 | Malignant rheumatoid arthritis | 7 |
| 107 | Juvenile idiopathic arthritis [Systemic juvenile idiopathic arthritis (~Mar 2018)] | 1 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03378219 (ClinicalTrials.gov) | May 18, 2018 | 15/12/2017 | An Observational Study on Sarilumab-exposed Pregnancies | Kevzara® (Sarilumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study | Rheumatoid Arthritis -Exposure During Pregnancy | Drug: Sarilumab SAR153191 (REGN88) | Sanofi | Regeneron Pharmaceuticals | Recruiting | N/A | N/A | Female | 300 | United States;Canada | |
| 2 | NCT02404558 (ClinicalTrials.gov) | May 2015 | 26/3/2015 | Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis | An 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 Arthritis | Rheumatoid Arthritis | Drug: sarilumab SAR153191 (REGN88);Drug: tocilizumab | Sanofi | Regeneron Pharmaceuticals | Completed | 20 Years | N/A | Both | 30 | Phase 1 | Japan |
| 3 | NCT02293902 (ClinicalTrials.gov) | November 2014 | 13/11/2014 | 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) | 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 Therapy | Rheumatoid Arthritis | Drug: Sarilumab SAR153191 (REGN88);Other: Placebo (for sarilumab);Drug: Methotrexate;Drug: Folic acid | Sanofi | Regeneron Pharmaceuticals | Completed | 20 Years | 75 Years | All | 243 | Phase 3 | Japan |
| 4 | NCT02121210 (ClinicalTrials.gov) | June 2014 | 21/4/2014 | To 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 Arthritis | Rheumatoid Arthritis | Drug: sarilumab SAR153191 (REGN88) | Sanofi | Regeneron Pharmaceuticals | Completed | 18 Years | N/A | All | 132 | Phase 3 | United States;Chile;Czechia;Estonia;Hungary;Poland;Russian Federation;Czech Republic |
| 5 | NCT02017639 (ClinicalTrials.gov) | January 2014 | 2/12/2013 | Sarilumab Effect on the Pharmacokinetics of Simvastatin | A 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 Arthritis | Rheumatoid Arthritis | Drug: sarilumab SAR153191 (REGN88);Drug: simvastatin | Sanofi | Regeneron Pharmaceuticals | Completed | 18 Years | 75 Years | Both | 19 | Phase 1 | United States;Korea, Republic of;Moldova, Republic of |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT01850680 (ClinicalTrials.gov) | April 2013 | 1/5/2013 | Single Ascending Dose Study of Safety and Tolerability of Sarilumab and Methotrexate in Japanese Patients With Rheumatoid Arthritis | A 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 Methotrexate | Rheumatoid Arthritis | Drug: sarilumab SAR153191 (REGN88);Drug: placebo;Drug: methotrexate;Drug: folic acid | Sanofi | Regeneron Pharmaceuticals | Completed | 20 Years | 65 Years | Both | 61 | Phase 1 | Japan |
| 7 | NCT01768572 (ClinicalTrials.gov) | March 2013 | 11/1/2013 | 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) | 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 Antagonists | Rheumatoid Arthritis | Drug: sarilumab SAR153191 (REGN88);Drug: tocilizumab;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide;Drug: subcutaneous placebo;Drug: intravenous placebo | Sanofi | Regeneron Pharmaceuticals | Completed | 18 Years | N/A | All | 202 | Phase 3 | United States;Argentina;Belgium;Brazil;Czechia;Estonia;Finland;Hungary;Israel;Italy;Mexico;Netherlands;Norway;Poland;Romania;Russian Federation;Spain;Sweden;United Kingdom;Czech Republic |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02991469 (ClinicalTrials.gov) | August 9, 2018 | 14/10/2016 | A 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 Phase | Juvenile Idiopathic Arthritis | Drug: Sarilumab SAR153191 (REGN88) | Sanofi | Regeneron Pharmaceuticals | Recruiting | 1 Year | 17 Years | All | 72 | Phase 2 | Argentina;Canada;Czechia;Finland;France;Germany;Italy;Russian Federation;Spain;United Kingdom;Chile;Estonia;Netherlands;Poland;United States |