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

Completed · Phase 1

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT01328522

Run by

Sanofi

People needed

32

Starts

2011-05-01

Expected to finish

2011-09-01

Last updated by the study team

2011-10-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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