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

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