Status:
COMPLETED
Study of LX3305 in Subjects With Active Rheumatoid Arthritis on Stable Methotrexate
Lead Sponsor:
Lexicon Pharmaceuticals
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT00903383
Start Date
July 1 2009
Last Update
December 15 2011
Active Locations (38)
Enter a location and click search to find clinical trials sorted by distance.
1
Lexicon Investigational Site
Gainesville, Florida, United States, 32607
2
Lexicon Investigational Site
Orange Park, Florida, United States, 32073
3
Lexicon Investigational Site
Orlando, Florida, United States, 32804
4
Lexicon Investigational Site
Tampa, Florida, United States, 33614