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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lexicon Pharmaceuticals
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)