NCT01026519

A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis

A Single-dose, Double-Blind, Placebo-Controlled, Parallel Group Safety, Tolerability and Pharmacodynamic Study of Subcutaneous REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-dose, double-blind, placebo-controlled, parallel group safety, tolerability and pharmacodynamic study of subcutaneously (SC) administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate. Four (4) parallel groups of 8 subjects each with active rheumatoid arthritis will be dosed SC.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	REGN88	Single dose of REGN88 and 43 day follow up.
OTHER	Placebo	Placebo to match REGN88 administration

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-03-01
• Completion: 2009-05-01
• First posted: 2009-12-04
• Last updated: 2013-09-30

Locations

1 site across 1 country: Russia