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)
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: sarilumab SAR153191 (REGN88)Drug: tocilizumabDrug: hydroxychloroquineDrug: methotrexateDrug: sulfasalazineDrug: leflunomideDrug: intravenous placeboDrug: subcutaneous placebo
- Registration Number
- NCT01768572
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To assess, in the same study, the safety of sarilumab and tocilizumab in participants with rheumatoid arthritis (RA) who were inadequate responders to or intolerant of tumor necrosis factor (TNF) antagonists.
- Detailed Description
Total study duration was up to 34 weeks: Screening up to 28 days, treatment phase of 24 weeks, and post-treatment follow-up of 6 weeks.
After completion of the treatment phase of this study, participants were eligible to enter a long term safety study (LTS11210) for active treatment with SAR153191 (REGN88).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 202
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sarilumab 150 mg q2w sarilumab SAR153191 (REGN88) Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) and placebo intravenous (IV) infusion once every 4 weeks (q4w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD), hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. Sarilumab 150 mg q2w intravenous placebo Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) and placebo intravenous (IV) infusion once every 4 weeks (q4w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD), hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. Sarilumab 150 mg q2w methotrexate Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) and placebo intravenous (IV) infusion once every 4 weeks (q4w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD), hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. Sarilumab 200 mg q2w intravenous placebo Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. Tocilizumab q4w subcutaneous placebo Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. Sarilumab 200 mg q2w sarilumab SAR153191 (REGN88) Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. Sarilumab 200 mg q2w hydroxychloroquine Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. Sarilumab 150 mg q2w hydroxychloroquine Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) and placebo intravenous (IV) infusion once every 4 weeks (q4w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD), hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. Sarilumab 150 mg q2w sulfasalazine Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) and placebo intravenous (IV) infusion once every 4 weeks (q4w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD), hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. Sarilumab 150 mg q2w leflunomide Sarilumab 150 mg subcutaneous (SC) injection once every 2 weeks (q2w) and placebo intravenous (IV) infusion once every 4 weeks (q4w) was added to one or a combination of the nonbiologic disease modifying antirheumatic drug (DMARD), hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. Sarilumab 200 mg q2w leflunomide Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. Sarilumab 200 mg q2w sulfasalazine Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. Sarilumab 200 mg q2w methotrexate Sarilumab 200 mg SC injection q2w and placebo IV infusion q4w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. Tocilizumab q4w tocilizumab Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. Tocilizumab q4w sulfasalazine Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. Tocilizumab q4w hydroxychloroquine Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. Tocilizumab q4w methotrexate Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate. Tocilizumab q4w leflunomide Tocilizumab 4 mg/kg or 8 mg/kg IV infusion q4w and placebo SC injection q2w was added to one or a combination of the nonbiologic DMARD, hydroxychloroquine, methotrexate, sulfasalazine and/or leflunomide for 24 weeks, except for the simultaneous use of leflunomide and methotrexate.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Adverse Events (TEAEs) Up to 211 days Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and does not necessary have to have a causal relationship with treatment. All adverse events that occurred from the first dose of the study drug administration up to 60 days after the end of treatment visit were considered as TEAEs. Serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly or a medically important event. A summary of SAEs, all other non-serious AEs, regardless of causality, are reported in AE section.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (78)
Investigational Site Number 840033
🇺🇸Fort Lauderdale, Florida, United States
Investigational Site Number 840150
🇺🇸Lansing, Michigan, United States
Investigational Site Number 840022
🇺🇸Dallas, Texas, United States
Investigational Site Number 840156
🇺🇸Dallas, Texas, United States
Investigational Site Number 032006
🇦🇷Caba, Argentina
Investigational Site Number 840074
🇺🇸Mesquite, Texas, United States
Investigational Site Number 032015
🇦🇷San Fernando, Argentina
Investigational Site Number 076001
🇧🇷Curitiba, Brazil
Investigational Site Number 203009
🇨🇿Liberec, Czechia
Investigational Site Number 203011
🇨🇿Praha 2, Czechia
Investigational Site Number 203010
🇨🇿Praha 4, Czechia
Investigational Site Number 246001
🇫🇮Helsinki, Finland
Investigational Site Number 348016
🇭🇺Kistarcsa, Hungary
Investigational Site Number 348009
🇭🇺Szolnok, Hungary
Investigational Site Number 348015
🇭🇺Szombathely, Hungary
Investigational Site Number 376010
🇮🇱Haifa, Israel
Investigational Site Number 484001
🇲🇽México, D.F., Mexico
Investigational Site Number 578010
🇳🇴Kristiansand, Norway
Investigational Site Number 528001
🇳🇱Leiden, Netherlands
Investigational Site Number 616019
🇵🇱Bydgoszcz, Poland
Investigational Site Number 642006
🇷🇴Braila, Romania
Investigational Site Number 616017
🇵🇱Warszawa, Poland
Investigational Site Number 642001
🇷🇴Bucuresti, Romania
Investigational Site Number 642021
🇷🇴Bucuresti, Romania
Investigational Site Number 642022
🇷🇴Targoviste, Romania
Investigational Site Number 643031
🇷🇺Moscow, Russian Federation
Investigational Site Number 643017
🇷🇺Kemerovo, Russian Federation
Investigational Site Number 643020
🇷🇺Moscow, Russian Federation
Investigational Site Number 643002
🇷🇺Moscow, Russian Federation
Investigational Site Number 643032
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 643030
🇷🇺Moscow, Russian Federation
Investigational Site Number 724021
🇪🇸Santander, Spain
Investigational Site Number 724020
🇪🇸Barcelona, Spain
Investigational Site Number 752004
🇸🇪Malmö, Sweden
Investigational Site Number 724022
🇪🇸Sevilla, Spain
Investigational Site Number 752002
🇸🇪Uppsala, Sweden
Investigational Site Number 826006
🇬🇧Edinburgh, United Kingdom
Investigational Site Number 826004
🇬🇧Doncaster, United Kingdom
Investigational Site Number 826005
🇬🇧Southampton, United Kingdom
Investigational Site Number 826001
🇬🇧Leeds, United Kingdom
Investigational Site Number 826002
🇬🇧London, United Kingdom
Investigational Site Number 826025
🇬🇧Wigan, United Kingdom
Investigational Site Number 840151
🇺🇸Colorado Springs, Colorado, United States
Investigational Site Number 840048
🇺🇸Miami, Florida, United States
Investigational Site Number 840038
🇺🇸Austin, Texas, United States
Investigational Site Number 840152
🇺🇸Huntsville, Alabama, United States
Investigational Site Number 840062
🇺🇸Reading, Pennsylvania, United States
Investigational Site Number 840154
🇺🇸Boston, Massachusetts, United States
Investigational Site Number 032005
🇦🇷Tucuman, Argentina
Investigational Site Number 348022
🇭🇺Budapest, Hungary
Investigational Site Number 032013
🇦🇷Rosario, Argentina
Investigational Site Number 076030
🇧🇷Sao Jose Do Rio Preto, Brazil
Investigational Site Number 233010
🇪🇪Tallinn, Estonia
Investigational Site Number 233002
🇪🇪Tallinn, Estonia
Investigational Site Number 840153
🇺🇸Aventura, Florida, United States
Investigational Site Number 246010
🇫🇮Riihimäki, Finland
Investigational Site Number 528010
🇳🇱Amsterdam, Netherlands
Investigational Site Number 616054
🇵🇱Bytom, Poland
Investigational Site Number 642020
🇷🇴Bucharest, Romania
Investigational Site Number 642010
🇷🇴Bucharest, Romania
Investigational Site Number 348021
🇭🇺Esztergom, Hungary
Investigational Site Number 376011
🇮🇱Tel Aviv, Israel
Investigational Site Number 380002
🇮🇹Firenze, Italy
Investigational Site Number 380005
🇮🇹Genova, Italy
Investigational Site Number 484008
🇲🇽Durango, Mexico
Investigational Site Number 484035
🇲🇽Leon, Mexico
Investigational Site Number 484036
🇲🇽Zapopan, Mexico
Investigational Site Number 616030
🇵🇱Lublin, Poland
Investigational Site Number 348014
🇭🇺Budapest, Hungary
Investigational Site Number 032010
🇦🇷Ramos Mejia, Argentina
Investigational Site Number 032004
🇦🇷San Miguel De Tucuman, Argentina
Investigational Site Number 056010
🇧🇪Leuven, Belgium
Investigational Site Number 484009
🇲🇽Merida, Mexico
Investigational Site Number 578006
🇳🇴Tønsberg, Norway
Investigational Site Number 616031
🇵🇱Warszawa, Poland
Investigational Site Number 643001
🇷🇺Moscow, Russian Federation
Investigational Site Number 840155
🇺🇸Palm Harbor, Florida, United States
Investigational Site Number 840013
🇺🇸Wheaton, Maryland, United States