Status:
COMPLETED
Study of LX3305 and Methotrexate in Subjects With Stable Rheumatoid Arthritis
Lead Sponsor:
Lexicon Pharmaceuticals
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of the study is to evaluate the effect of LX3305 on methotrexate (MTX) pharmacokinetics and to evaluate the safety and tolerability of LX3305 given over 14 days in subjects with stable rhe...
Eligibility Criteria
Inclusion
- Males and females ≥ 18 years old
- Must be willing to practice 2 adequate methods of contraception for the duration of the study
- Rheumatoid arthritis present for at least 3 months; functional class I, II, or III as defined by ACR criteria
- Treatment with methotrexate (7.5 to 25 mg per week) for at least the last 3 months, and currently receiving stable dose methotrexate for at least one month prior to the start of the study
- Ability to provide written informed consent
Exclusion
- Women who are pregnant or nursing
- History of other current inflammatory arthritis
- History of opportunistic infection
- History of recurrent infections or current infection 2 weeks prior to start of study
- Presence of significant, uncontrolled medical problems
- Treatment with any disease-modifying anti-rheumatoid drugs other than methotrexate within 4 weeks prior to start of study
- Use of chondroitin sulfate, glucosamine sulfate, minocycline, or matrix metalloproteinase inhibitors, H-2 blockers, proton pump inhibitors, or misoprostol within 4 weeks prior to study start
- Receipt of live vaccine within 8 weeks prior to study start
- Rheumatoid arthritis, functional class IV as defined by ACR criteria
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00847886
Start Date
February 1 2009
End Date
March 1 2009
Last Update
June 3 2010
Active Locations (1)
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1
Metroplex Clinical Research Center
Dallas, Texas, United States, 75235