Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Lexicon Pharmaceuticals
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
