Rheumatoid Arthritis Clinical Trial
Official title:
A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects With Active Rheumatoid Arthritis (RA)
Verified date | August 2012 |
Source | Lexicon Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 10 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Lexicon Investigational Site | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Lexicon Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of subjects experiencing an adverse event (AE) | 14 weeks | No | |
Secondary | Change from baseline in absolute lymphocyte counts | 14 weeks | No | |
Secondary | Maximum observed plasma concentration | 14 weeks | No | |
Secondary | Time at which maximum observed plasma concentration occurs | 14 weeks | No | |
Secondary | Half-life of drug in plasma | 14 weeks | No | |
Secondary | Changes from baseline in global health | 14 weeks | No |
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