NCT01052194

A 12-week Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis

A 12-week, Double-blind, Randomized, Parallel-group, Placebo-controlled Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate safety and assess initial efficacy of VX-509, a JAK3 inhibitor, for treatment of subjects with active RA. This study will assess the clinical response of 4 doses of VX-509 compared to placebo when administered for 12 weeks to patients with active RA. The study will also evaluate the safety and tolerability of VX-509 compared to placebo when administered for 12 weeks to subjects with active RA.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Placebo	tablet, placebo b.i.d. for 12 weeks
DRUG	VX-509	tablets, 25mg b.i.d. for 12 weeks
DRUG	VX-509	tablet, 50 mg b.i.d. for 12 weeks
DRUG	VX-509	tablet, 100 mg b.i.d. for 12 weeks
DRUG	VX-509	tablet, 150 mg b.i.d. for 12 weeks

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-01-20
• Last updated: 2012-12-13

Locations

48 sites across 10 countries: United States, Belgium, Croatia, Germany, Hungary, Poland, Puerto Rico, Romania, Russia, Serbia