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

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals

Criteria

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.