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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: SAR153191 (REGN88)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAR153191 drug product 1<br>SAR153191 drug product 1 in a single injection. Methotrexate (stable dose) and folic/folinic acid are continued as background therapy. | Drug: SAR153191 (REGN88)<br>* Pharmaceutical form:solution Route of administration: subcutaneous<br>|
| Experimental: SAR153191 drug product 2<br>SAR153191 drug product 2 in a single injection. Methotrexate (stable dose) and folic/folinic acid are continued as background therapy. | Drug: SAR153191 (REGN88)<br>* Pharmaceutical form:solution Route of administration: subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of potentially clinically significant abnormalities in clinical laboratory test results |  | 5 weeks | 
| Occurrence of Adverse Events |  | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain evaluation using the Present Pain Intensity (PPI) verbal questionnaire |  | 2 days | 
| Pain evaluation using Visual Analog Scale (VAS) |  | 2 days | 
| Diameter of the erythema at injection site |  | 2 days | 
| Diameter of the edema at injection site |  | 2 days | 
| Serum concentration of SAR153191: Maximum plasma concentration (Cmax), first time to reach Cmax (tmax), area under the plasma concentration (AUClast and AUC) |  | 5 weeks |