To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis (SARIL-RA-EASY)
RA
About this trial
This is an interventional treatment trial for RA
Eligibility Criteria
Inclusion criteria:
- Diagnosis of RA, ≥3 months disease duration;
- Participant willing and able to self-inject;
- Continuous treatment with 1 or a combination of non-biologic disease modifying antirheumatic drugs (DMARDs) (except leflunomide in combination with methotrexate);
- Moderate-to-severely active RA.
Exclusion criteria:
- Participants <18 years;
- Prior treatment with anti-interleukin 6 (IL-6) or IL-6 receptor (IL-6R) antagonists;
- Treatment with tumor necrosis factor (TNF) antagonists;
- Treatment with RA-directed biologic agents other than with a TNF-α antagonist mechanism as follows: Anakinra, Abatacept, Rituximab or other cell-depleting agent;
- Prior treatment with a Janus kinase inhibitor.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Sites / Locations
- Investigational Site Number 840152
- Investigational Site Number 840221
- Investigational Site Number 840226
- Investigational Site Number 840223
- Investigational Site Number 840229
- Investigational Site Number 840236
- Investigational Site Number 840155
- Investigational Site Number 840220
- Investigational Site Number 840202
- Investigational Site Number 840232
- Investigational Site Number 840233
- Investigational Site Number 840037
- Investigational Site Number 840112
- Investigational Site Number 840039
- Investigational Site Number 840224
- Investigational Site Number 840002
- Investigational Site Number 840065
- Investigational Site Number 840009
- Investigational Site Number 840062
- Investigational Site Number 840016
- Investigational Site Number 840025
- Investigational Site Number 840038
- Investigational Site Number 840230
- Investigational Site Number 840001
- Investigational Site Number 840020
- Investigational Site Number 840239
- Investigational Site Number 840241
- Investigational Site Number 840242
- Investigational Site Number 840069
- Investigational Site Number 840074
- Investigational Site Number 840237
- Investigational Site Number 152005
- Investigational Site Number 152050
- Investigational Site Number 152014
- Investigational Site Number 152007
- Investigational Site Number 484002
- Investigational Site Number 484004
- Investigational Site Number 484005
- Investigational Site Number 616002
- Investigational Site Number 616005
- Investigational Site Number 616004
- Investigational Site Number 616017
- Investigational Site Number 616012
- Investigational Site Number 643006
- Investigational Site Number 643020
- Investigational Site Number 643001
- Investigational Site Number 643008
- Investigational Site Number 710050
- Investigational Site Number 710011
- Investigational Site Number 710007
- Investigational Site Number 710003
- Investigational Site Number 710001
- Investigational Site Number 710051
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Sarilumab 150 mg by AID
Sarilumab 150 mg by PFS
Sarilumab 200 mg by AID
Sarilumab 200 mg by PFS
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 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 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 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.