NCT00903383

Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate

A Phase 2, Multi-center, Randomized, Double Blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Lexicon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX3305 versus a placebo control in subjects with active rheumatoid arthritis on stable methotrexate therapy.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	LX3305 low dose	A low dose of LX3305; daily oral intake for 12 weeks
DRUG	LX3305 mid dose	A mid dose of LX3305; daily oral intake for 12 weeks
DRUG	LX3305 high dose	A high dose of LX3305; daily oral intake for 12 weeks
DRUG	Placebo	Matching placebo dosing with daily oral intake for 12 weeks

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-09-01
• First posted: 2009-05-18
• Last updated: 2011-12-15
• Results posted: 2011-12-15

Locations

38 sites across 6 countries: United States, Bulgaria, Czechia, Hungary, Poland, Serbia