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To Evaluate Sarilumab - SAR153191 (REGN88) - Auto-injector Device In Patients With Rheumatoid Arthritis (SARIL-RA-EASY)

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Sanofi

Status and phase

Completed
Phase 3

Conditions

RA

Treatments

Device: Pre-filled Syringe (PFS)
Drug: Sarilumab
Drug: Sulfasalazine
Drug: Methotrexate
Drug: Leflunomide
Device: Auto-Injector Device (AID)
Drug: Hydroxychloroquine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02057250
U1111-1130-9931 (Other Identifier)
2012-004339-21
MSC12665

Details and patient eligibility

About

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).

Full 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).

Enrollment

217 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

217 participants in 4 patient groups

Sarilumab 150 mg by AID
Experimental group
Description:
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.
Treatment:
Drug: Sulfasalazine
Drug: Leflunomide
Drug: Methotrexate
Drug: Sarilumab
Drug: Hydroxychloroquine
Device: Auto-Injector Device (AID)
Sarilumab 150 mg by PFS
Experimental group
Description:
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.
Treatment:
Drug: Sulfasalazine
Drug: Leflunomide
Drug: Methotrexate
Device: Pre-filled Syringe (PFS)
Drug: Sarilumab
Drug: Hydroxychloroquine
Sarilumab 200 mg by AID
Experimental group
Description:
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.
Treatment:
Drug: Sulfasalazine
Drug: Leflunomide
Drug: Methotrexate
Drug: Sarilumab
Drug: Hydroxychloroquine
Device: Auto-Injector Device (AID)
Sarilumab 200 mg by PFS
Experimental group
Description:
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.
Treatment:
Drug: Sulfasalazine
Drug: Leflunomide
Drug: Methotrexate
Device: Pre-filled Syringe (PFS)
Drug: Sarilumab
Drug: Hydroxychloroquine

Trial contacts and locations

53

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Data sourced from clinicaltrials.gov

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