NCT01055899

Safety Study of a Single Dose of REGN88(SAR153191)in Patients With Rheumatoid Arthritis

A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety and Tolerability of Subcutaneously Administered REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test the safety and tolerability (how the body reacts to the drug) of REGN88 and placebo (an inactive substance that contains no medicine) in patients with Rheumatoid Arthritis.

Detailed description

This is a multi-center, randomized, double blind, placebo-controlled, single dose escalation study of the safety and tolerability of subcutaneously administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate. Three (3) sequential dose cohorts of 5 subjects (4:1 active: placebo) will be dosed SC with REGN88 or placebo. Subjects who complete the study will participate in 14 study visits over 16 weeks.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	REGN88	Single SC Dose
BIOLOGICAL	REGN88	Single SC Dose
BIOLOGICAL	REGN88	Single SC Dose

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2010-01-26
• Last updated: 2013-09-30

Locations

2 sites across 1 country: United States