Comparison of the Safety and Pharmacokinetics of Two SAR153191 (REGN88) Drug Products in Rheumatoid Arthritis Patients

• Occurrence of potentially clinically significant abnormalities in clinical laboratory test results [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
• Occurrence of Adverse Events [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]

• Pain evaluation using the Present Pain Intensity (PPI) verbal questionnaire [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
• Pain evaluation using Visual Analog Scale (VAS) [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
• Diameter of the erythema at injection site [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
• Diameter of the edema at injection site [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
• Serum concentration of SAR153191: Maximum plasma concentration (Cmax), first time to reach Cmax (tmax), area under the plasma concentration (AUClast and AUC) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Primary Objective:

Assess the comparative safety and tolerability of two SAR153191 (REGN88) drug products after a single dose administration in rheumatoid arthritis patients.

Secondary Objective:

Assess the comparative pharmacokinetic profiles of the two SAR153191 (REGN88) drug products after a single dose administration in rheumatoid arthritis patients.

The duration of the study period per subject is 5-7 weeks broken down as follows:

• Screening: 1 to 14 days,
• Treatment: 1 day (2 overnight stays at the study site),
• Follow-up: up to 5 weeks after dosing (an additional outpatient follow-up may be scheduled depending on the last results).

• Experimental: SAR153191 drug product 1

  SAR153191 drug product 1 in a single injection.

  Methotrexate (stable dose) and folic/folinic acid are continued as background therapy.

  Intervention: Drug: SAR153191 (REGN88)
• Experimental: SAR153191 drug product 2

  SAR153191 drug product 2 in a single injection.

  Methotrexate (stable dose) and folic/folinic acid are continued as background therapy.

  Intervention: Drug: SAR153191 (REGN88)

Inclusion criteria:

• Diagnosis of rheumatoid arthritis (RA) > or = 3 months duration.
• Treated for a minimum of 12 weeks with Methotrexate (MTX) prior to randomization. Treatment must be continued on a stable dose for the duration of the study.

Exclusion criteria:

• Autoimmune disease other than RA.
• History of acute inflammatory joint disease other than RA.
• Surgery within 4 weeks prior to the screening visit or with planned elective surgery within the next 3 months.
• Latent or active tuberculosis.
• Fever (≥38 C) or persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit, or history of frequent recurrent infections.
• Received administration of any live (attenuated) vaccine within 3 months prior to the randomization visit (eg, varicella-zoster vaccine, oral polio, rabies).
• Received tuberculosis vaccination within 12 months prior to screening
• Prior therapy with a Tumor Necrosis Factor (TNF) antagonist or any other biologic agents within 3 months prior to inclusion.
• Known latex sensitivity.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.