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

Phase 1

Conditions: Rheumatoid Arthritis
MedDRA version: 18.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2012-004339-21-PL

Lead Sponsor: sanofi-aventis Recherche & Développement

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

Diagnosis of rheumatoid arthritis (RA), =3 months disease duration
Patient willing and able to self-inject
Continuous treatment with 1 or a combination of nonbiologic DMARDs (except leflunomide in combination with methotrexate)
Moderate-to-severely active RA defined as: = 4/66 swollen and ….

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

Patients<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 TNFa antagonist mechanism as follows: Anakinra, Abatacept, Rituximab or other cell-depleting agent
Prior treatment with a Janus kinase inhibitor

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To collect real-use data of the sarilumab auto-injector used by rheumatoid arthritis (RA) patients;Secondary Objective: To compare the pharmacokinetic (PK) exposure of sarilumab administered by AID versus prefilled syringes (PFS);Primary end point(s): Number of validated AID-associated product technical failures (PTFs);Timepoint(s) of evaluation of this end point: Up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Sarilumab exposure using the auto-injector (AID) versus the prefilled syringe (PFS);Timepoint(s) of evaluation of this end point: Up to 12 weeks (during the AID assessment phase)