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

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Multicenter, Randomized, Open-Label, Parallel-Group Usability Study Of The Sarilumab Auto-Injector Device And A Prefilled Syringe In Patients With Moderate To Severe Active Rheumatoid Arthritis Who Are Candidates For Anti-IL6R Therapy

Conditions
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RA

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sarilumab 150 mg by AID<br>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. | Drug: Sarilumab<br>* Pharmaceutical form: Solution Route of administration: Subcutaneous<br>* Other names: REGN88;Device: Auto-Injector Device (AID)<br> <br> Drug: Methotrexate<br>* Dispensed according to local practice.<br>Drug: Sulfasalazine<br>* Dispensed according to local practice.<br>Drug: Leflunomide<br>* Dispensed according to local practice.<br>Drug: Hydroxychloroquine<br>* Dispensed according to local practice.<br>|
| Experimental: Sarilumab 150 mg by PFS<br>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. | Drug: Sarilumab<br>* Pharmaceutical form: Solution Route of administration: Subcutaneous<br>* Other names: REGN88;Device: Pre-filled Syringe (PFS)<br> <br> Drug: Methotrexate<br>* Dispensed according to local practice.<br>Drug: Sulfasalazine<br>* Dispensed according to local practice.<br>Drug: Leflunomide<br>* Dispensed according to local practice.<br>Drug: Hydroxychloroquine<br>* Dispensed according to local practice.<br>|
| Experimental: Sarilumab 200 mg by AID<br>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. | Drug: Sarilumab<br>* Pharmaceutical form: Solution Route of administration: Subcutaneous<br>* Other names: REGN88;Device: Auto-Injector Device (AID)<br> <br> Drug: Methotrexate<br>* Dispensed according to local practice.<br>Drug: Sulfasalazine<br>* Dispensed according to local practice.<br>Drug: Leflunomide<br>* Dispensed according to local practice.<br>Drug: Hydroxychloroquine<br>* Dispensed according to local practice.<br>|
| Experimental: Sarilumab 200 mg by PFS<br>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. | Drug: Sarilumab<br>* Pharmaceutical form: Solution Route of administration: Subcutaneous<br>* Other names: REGN88;Device: Pre-filled Syringe (PFS)<br> <br> Drug: Methotrexate<br>* Dispensed according to local practice.<br>Drug: Sulfasalazine<br>* Dispensed according to local practice.<br>Drug: Leflunomide<br>* Dispensed according to local practice.<br>Drug: Hydroxychloroquine<br>* Dispensed according to local practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Validated AID Associated Product Technical Failures (PTFs) | 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. | Baseline up to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Serum Concentration Versus Time Curve Calculated Using the Trapezoidal Method During a Dose Interval (AUC[0-tau]) for Sarilumab | 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). | 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 |