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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00903383

Run by

Lexicon Pharmaceuticals

People needed

208

Starts

2009-07-01

Last updated by the study team

2011-12-15

Who can join

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

You may qualify if…

• Males and females aged 18-75 years old
• Rheumatoid arthritis present for at least 6 months, functional class I, II, or III as defined by ACR criteria
• Active disease as determined by the presence of ≥6 swollen joints, ≥6 tender joints, and serum C-reactive protein level > upper limit of normal
• Receiving stable dose of MTX (≥10 mg/wk) and folate supplementation at least 8 weeks prior to Day 1
• Ability to provide written informed consent

You may not qualify if…

• RA diagnosis prior to 16 years of age (Juvenile RA)
• Lack of response to >3 disease modifying anti-rheumatic drugs (DMARDs) or exposure to >1 biologic DMARD
• Use of DMARDs other than MTX within 12 weeks prior to Day 1
• Intra-articular and/or parenteral corticosteroids within 4 weeks prior to study Day 1
• Blood donation or receipt of live vaccine within 4 weeks prior to Day 1
• Major surgical procedure within 8 weeks prior to Day 1
• Any systemic inflammatory condition, recurrent infection, or current infection other than onychomycosis
• History of cancer within 5 years prior to Day 1
• Presence of hepatic or biliary disease
• History of tuberculosis
• History of human immunodeficiency virus (HIV)

Where it is running

• Lexicon Investigational Site — Gainesville, Florida, United States
• Lexicon Investigational Site — Orange Park, Florida, United States
• Lexicon Investigational Site — Orlando, Florida, United States
• Lexicon Investigational Site — Tampa, Florida, United States
• Lexicon Investigational Site — Cumberland, Maryland, United States
• Lexicon Investigational Site — Hagerstown, Maryland, United States
• Lexicon Investigational Site — Kalamazoo, Michigan, United States
• Lexicon Investigational Site — Flowood, Mississippi, United States
• Lexicon Investigational Site — Hickory, North Carolina, United States
• Lexicon Investigational Site — Philadelphia, Pennsylvania, United States
• Lexicon Investigational Site — Nashville, Tennessee, United States
• Lexicon Investigational Site — Dallas, Texas, United States
• Lexicon Investigational Site — La Crosse, Wisconsin, United States
• Lexicon Investigational Site — Pleven, Bulgaria
• Lexicon Investigational Site — Plovdiv, Bulgaria
• Lexicon Investigational Site — Rousse, Bulgaria
• Lexicon Investigational Site — Sofia, Bulgaria
• Lexicon Investigational Site — Veliko Tarnovo, Bulgaria
• Lexicon Investigational Site — Bruntál, Czechia
• Lexicon Investigational Site — Hlučín, Czechia
• Lexicon Investigational Site — Sokolov, Czechia
• Lexicon Investigational Site — Zlín, Czechia
• Lexicon Investigational Site — Békéscsaba, Hungary
• Lexicon Investigational Site — Budapest, Hungary
• Lexicon Investigational Site — Kecskemét, Hungary

Full record on ClinicalTrials.gov

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