To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis
- Conditions
- RA
- Interventions
- Device: Auto-Injector Device (AID)Device: Pre-filled Syringe (PFS)
- Registration Number
- NCT02057250
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To collect real-use data of the sarilumab auto-injector device (AID) used by rheumatoid arthritis (RA) participants.
Secondary Objective:
To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus prefilled syringes (PFS).
- Detailed Description
Total study duration up to 74 weeks: screening up to 4 weeks, AID assessment phase of 12 weeks, extension phase of 52 weeks and post-treatment follow-up of 6 weeks.
For participants not entering the extension phase, total study duration up to 22 weeks (screening, AID assessment phase and follow-up).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 217
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sarilumab 150 mg by PFS Sarilumab Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 200 mg by PFS Sarilumab Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 150 mg by AID Sarilumab Sarilumab 150 mg subcutaneous (SC) injection every 2 weeks (q2w) administered by AID with one or a combination of non-biologic disease-modifying anti-rheumatic drug (DMARD) (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 150 mg by AID Auto-Injector Device (AID) Sarilumab 150 mg subcutaneous (SC) injection every 2 weeks (q2w) administered by AID with one or a combination of non-biologic disease-modifying anti-rheumatic drug (DMARD) (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 150 mg by PFS Pre-filled Syringe (PFS) Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 200 mg by AID Auto-Injector Device (AID) Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 200 mg by PFS Pre-filled Syringe (PFS) Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 150 mg by AID Methotrexate Sarilumab 150 mg subcutaneous (SC) injection every 2 weeks (q2w) administered by AID with one or a combination of non-biologic disease-modifying anti-rheumatic drug (DMARD) (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 150 mg by AID Sulfasalazine Sarilumab 150 mg subcutaneous (SC) injection every 2 weeks (q2w) administered by AID with one or a combination of non-biologic disease-modifying anti-rheumatic drug (DMARD) (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 150 mg by AID Leflunomide Sarilumab 150 mg subcutaneous (SC) injection every 2 weeks (q2w) administered by AID with one or a combination of non-biologic disease-modifying anti-rheumatic drug (DMARD) (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 150 mg by AID Hydroxychloroquine Sarilumab 150 mg subcutaneous (SC) injection every 2 weeks (q2w) administered by AID with one or a combination of non-biologic disease-modifying anti-rheumatic drug (DMARD) (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 150 mg by PFS Methotrexate Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 150 mg by PFS Sulfasalazine Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 150 mg by PFS Leflunomide Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 150 mg by PFS Hydroxychloroquine Sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 200 mg by AID Sarilumab Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 200 mg by AID Hydroxychloroquine Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 200 mg by AID Methotrexate Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 200 mg by AID Sulfasalazine Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 200 mg by AID Leflunomide Sarilumab 200 mg SC injection q2w administered by AID with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 200 mg by PFS Methotrexate Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 200 mg by PFS Leflunomide Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 200 mg by PFS Sulfasalazine Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks. Sarilumab 200 mg by PFS Hydroxychloroquine Sarilumab 200 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD (hydroxychloroquine, methotrexate, sulfasalazine and/or Leflunomide, except for simultaneous combination use of leflunomide and methotrexate) in AID assessment phase for 12 weeks. Participants who completed 12 weeks AID assessment phase entered in open-label extension phase and received sarilumab 150 mg SC injection q2w administered by PFS with one or a combination of non-biologic DMARD for 52 weeks.
- Primary Outcome Measures
Name Time Method Number of Validated AID Associated Product Technical Failures (PTFs) Baseline up to Week 12 A PTF was defined as any product technical complaint (PTC) related to the use of the AID that had a validated technical cause. Each participant was given a diary having questions related to participant's ability to remove the cap, to start the injection, to complete the injection and regarding confirmation of completing the injection. Participants were asked to answer the questions each time they self-inject the sarilumab. If the response was "no" to any of the first 3 questions, this was considered as a PTC. The used AID, for which PTC was reported, was sent to sponsor, examined and evaluated for the occurrence of a PTF.
- Secondary Outcome Measures
Name Time Method Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab Week 0-2: pre-dose on Day 1, anytime post-dose on Day 3, Day 5, Day 8, Day 12, Day 15; Week 10-12: pre-dose on Day 71, anytime post-dose on Day 73, Day 75, Day 78, Day 82, Day 85 AUC(0-tau) is defined as area under the serum concentration versus time curve calculated using the trapezoidal method during a dose interval, where dose interval was 2 weeks. Serum concentrations of sarilumab were analyzed using validated enzyme linked immunosorbent assay (ELISA).
Trial Locations
- Locations (53)
Investigational Site Number 152050
🇨🇱Santiago, Chile
Investigational Site Number 152007
🇨🇱Viña Del Mar, Chile
Investigational Site Number 484005
🇲🇽Monterrey, Mexico
Investigational Site Number 616002
🇵🇱Bialystok, Poland
Investigational Site Number 484002
🇲🇽Guadalajara, Mexico
Investigational Site Number 484004
🇲🇽Merida, Mexico
Investigational Site Number 616017
🇵🇱Warszawa, Poland
Investigational Site Number 616005
🇵🇱Lublin, Poland
Investigational Site Number 616004
🇵🇱Warszawa, Poland
Investigational Site Number 616012
🇵🇱Wroclaw, Poland
Investigational Site Number 840233
🇺🇸Kalamazoo, Michigan, United States
Investigational Site Number 710050
🇿🇦Bellville, South Africa
Investigational Site Number 710003
🇿🇦Durban, South Africa
Investigational Site Number 840223
🇺🇸Boulder, Colorado, United States
Investigational Site Number 840155
🇺🇸Palm Harbor, Florida, United States
Investigational Site Number 840232
🇺🇸Flint, Michigan, United States
Investigational Site Number 710011
🇿🇦Cape Town, South Africa
Investigational Site Number 840062
🇺🇸Reading, Pennsylvania, United States
Investigational Site Number 840009
🇺🇸Duncansville, Pennsylvania, United States
Investigational Site Number 840065
🇺🇸Tulsa, Oklahoma, United States
Investigational Site Number 840220
🇺🇸South Miami, Florida, United States
Investigational Site Number 643001
🇷🇺Moscow, Russian Federation
Investigational Site Number 643006
🇷🇺Kemerovo, Russian Federation
Investigational Site Number 840039
🇺🇸Albany, New York, United States
Investigational Site Number 152005
🇨🇱Osorno, Chile
Investigational Site Number 840152
🇺🇸Huntsville, Alabama, United States
Investigational Site Number 840236
🇺🇸Orlando, Florida, United States
Investigational Site Number 840202
🇺🇸Hagerstown, Maryland, United States
Investigational Site Number 840229
🇺🇸Miami, Florida, United States
Investigational Site Number 840020
🇺🇸Houston, Texas, United States
Investigational Site Number 840241
🇺🇸Houston, Texas, United States
Investigational Site Number 840242
🇺🇸Houston, Texas, United States
Investigational Site Number 840002
🇺🇸Oklahoma City, Oklahoma, United States
Investigational Site Number 710001
🇿🇦Johannesburg, South Africa
Investigational Site Number 840221
🇺🇸Peoria, Arizona, United States
Investigational Site Number 840226
🇺🇸Roseville, California, United States
Investigational Site Number 840224
🇺🇸Cincinnati, Ohio, United States
Investigational Site Number 840001
🇺🇸Dallas, Texas, United States
Investigational Site Number 840112
🇺🇸Lincoln, Nebraska, United States
Investigational Site Number 840025
🇺🇸Jackson, Tennessee, United States
Investigational Site Number 840016
🇺🇸North Charleston, South Carolina, United States
Investigational Site Number 840069
🇺🇸Lubbock, Texas, United States
Investigational Site Number 152014
🇨🇱Talca, Chile
Investigational Site Number 840037
🇺🇸Tupelo, Mississippi, United States
Investigational Site Number 840239
🇺🇸Houston, Texas, United States
Investigational Site Number 643020
🇷🇺Moscow, Russian Federation
Investigational Site Number 710007
🇿🇦Cape Town, South Africa
Investigational Site Number 840074
🇺🇸Mesquite, Texas, United States
Investigational Site Number 840237
🇺🇸Plano, Texas, United States
Investigational Site Number 710051
🇿🇦Port Elizabeth, South Africa
Investigational Site Number 643008
🇷🇺Saint-Petersburg, Russian Federation
Investigational Site Number 840038
🇺🇸Austin, Texas, United States
Investigational Site Number 840230
🇺🇸Carrollton, Texas, United States