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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: SAR153191 (REGN88)

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Investigational Site Number 840003
  • Florida
    • Ocala, Florida, United States, 34471
      • Investigational Site Number 840001
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Investigational Site Number 840004
  • Texas
    • Dallas, Texas, United States, 75235
      • Investigational Site Number 840002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: SAR153191 (REGN88); Pharmaceutical form:solution Route of administration: subcutaneous
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.	Drug: SAR153191 (REGN88); Pharmaceutical form:solution Route of administration: subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: March 31, 2011
• First Submitted That Met QC Criteria: March 31, 2011
• First Posted (Estimate): April 4, 2011

Study Record Updates

• Last Update Posted (Estimate): October 24, 2011
• Last Update Submitted That Met QC Criteria: October 21, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: PKM12058; U1111-1119-2883 (Other Identifier: UTN)