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

Phase 1

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: SAR153191 (REGN88)

• Registration Number: NCT01328522
• Lead Sponsor: Sanofi

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2011-03-31
• Study First Submitted QC: 2011-03-31
• Study First Posted: 2011-04-04
• Study Start: 2011-05
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-21
• Last Update Posted: 2011-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAR153191 drug product 1	SAR153191 (REGN88)	SAR153191 drug product 1 in a single injection. Methotrexate (stable dose) and folic/folinic acid are continued as background therapy.
SAR153191 drug product 2	SAR153191 (REGN88)	SAR153191 drug product 2 in a single injection. Methotrexate (stable dose) and folic/folinic acid are continued as background therapy.

Primary Outcome Measures

Name	Time	Method
Occurrence of potentially clinically significant abnormalities in clinical laboratory test results	5 weeks
Occurrence of Adverse Events	5 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Investigational Site Number 840001; 🇺🇸 Ocala, Florida, United States

Investigational Site Number 840004; 🇺🇸 Duncansville, Pennsylvania, United States

Investigational Site Number 840002; 🇺🇸 Dallas, Texas, United States

Investigational Site Number 840003; 🇺🇸 Beverly Hills, California, United States