Status:
COMPLETED
A Study to Determine the Safety and Efficacy of LX3305 in Subjects With Active Rheumatoid Arthritis
Lead Sponsor:
Lexicon Pharmaceuticals
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to determine the safety of LX3305 in a dose escalation compared with placebo over 12 weeks in subjects with active rheumatoid arthritis (RA).
Eligibility Criteria
Inclusion
- Adult subjects, aged 18 to 75 years
- Active rheumatoid arthritis (RA), class I to III (defined by the American College of Rheumatology), diagnosed at least 3 months prior to Screening
- Minimum of 4 swollen joints (at Screening and Day 1), minimum of 4 tender joints (at Screening and Day 1), and serum C-reactive protein (CRP) level \>1.2x the upper limit of normal and/or elevated erythrocyte sedimentation rate (ESR)
- If receiving methotrexate (7.5 mg to 25 mg/week), subject must have been treated for at least 6 weeks prior to Screening and currently receiving a stable dose of methotrexate (MTX) with a stable route of administration, and have no plans to change MTX dose during the study
- Ability to give written informed consent
Exclusion
- Women who are pregnant or nursing
- RA diagnosis prior to 16 years of age (juvenile RA)
- Intra-articular and/or parenteral corticosteroids within 4 weeks of study Day 1
- Receipt of live vaccine within 4 weeks prior to Day 1
- Major surgical procedure within 8 weeks prior to Day 1
- Blood donation within 4 weeks prior to Day 1
- Any systemic inflammatory condition
- History of bleeding diathesis
- History of medically significant opportunistic infection
- History of drug or alcohol abuse within 3 years prior to Day 1
- 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)
- Any clinically significant laboratory test results, in the opinion of the investigator
- Use of any investigational agent or participation in an investigative trial within 30 days of Day 1
- Concurrent use of any biologic agent for the treatment of RA or concomitant disease modifying antirheumatoid drugs (other than MTX, hydroxychloroquine, leflunomide, and sulfasalazine - at stables doses for 8 weeks)
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01417052
Start Date
September 1 2011
End Date
June 1 2012
Last Update
August 2 2012
Active Locations (1)
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1
Lexicon Investigational Site
Dallas, Texas, United States, 75231