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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)

This study is currently Recruiting

September 2011 By Lexicon Pharmaceuticals

First Recieved on August 12, 2011

Last Updated on September 15, 2011

Sponsor: Lexicon Pharmaceuticals
Collaborators:
Information provided by: Lexicon Pharmaceuticals
Identifier: NCT01417052

Purpose

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).

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

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)

Investigators

  • Investigator: Joel Freiman, MD, MPH - Study Director - Lexicon Pharmaceuticals, Inc.

Locations

  • Lexicon Investigational Site

    Dallas, Texas 75231 United States

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