A Study to Determine the Safety and Efficacy of LX3305 in Subjects With Active Rheumatoid Arthritis

Last updated: August 1, 2012
Sponsor: Lexicon Pharmaceuticals
Overall Status: Completed

Phase

1

Condition

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Dermatomyositis (Connective Tissue Disease)

Treatment

N/A

Clinical Study ID

NCT01417052
LX3305.1-106-RA
LX3305.106
  • Ages 18-75
  • All Genders

Study 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

Inclusion Criteria:

  • Adult subjects, aged 18 to 75 years

  • Active rheumatoid arthritis (RA), class I to III (defined by the American College ofRheumatology), diagnosed at least 3 months prior to Screening

  • Minimum of 4 swollen joints (at Screening and Day 1), minimum of 4 tender joints (atScreening and Day 1), and serum C-reactive protein (CRP) level >1.2x the upper limitof normal and/or elevated erythrocyte sedimentation rate (ESR)

  • If receiving methotrexate (7.5 mg to 25 mg/week), subject must have been treated forat least 6 weeks prior to Screening and currently receiving a stable dose ofmethotrexate (MTX) with a stable route of administration, and have no plans to changeMTX dose during the study

  • Ability to give written informed consent

Exclusion

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 30days of Day 1

  • Concurrent use of any biologic agent for the treatment of RA or concomitant diseasemodifying antirheumatoid drugs (other than MTX, hydroxychloroquine, leflunomide, andsulfasalazine - at stables doses for 8 weeks)

Study Design

Total Participants: 10
Study Start date:
September 01, 2011
Estimated Completion Date:
June 30, 2012

Connect with a study center

  • Lexicon Investigational Site

    Dallas, Texas 75231
    United States

    Site Not Available

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