ABOUT THIS STUDY
- Must be legal age of consent
- Must have active rheumatoid arthritis based upon the American College of Rheumatology (ACR) 1987 (Revised Criteria); minimum disease criteria required for entry into the efficacy component of the study
- Must meet ACR 1991 Revised Criteria for Global Functional Status in RA, Class I, II, or III
- Must be receiving methotrexate for at least 12 weeks duration and on a stable dose for 4 weeks.
- Diagnosed with any other inflammatory arthritis or a secondary non-inflammatory
arthritis that would interfere with disease activity assessments.
- Subject receiving prior treatment with certain medications for rheumatoid arthritis
- Tuberculosis and/or a positive tuberculin reaction
- Significant trauma or major surgery within 2 months
- History of alcohol and/or drug abuse outside of a defined period of abstinence
- History of or a finding at screening of postural hypotension
- Any condition that would affect the oral absorption of the drug
- History of cancer and in remission less than 3 years or Grade III-IV congestive heart
- Having an infection of human immunodeficiency virus (HIV), Hepatitis B or C or
evidence of any active infection
- Abnormalities of clinical or laboratory assessments completed at the screening visit
such as elevated liver enzymes, decreased hemoglobin or an abnormal ECG
- Having a positive chemokine receptor 5 (CCR5) delta 32 mutation
- Requiring the use of certain medications
- Lactating or pregnant women or subjects have reproductive potential unwilling to use
an adequate method of birth control
- Chronic or recent serious or life-threatening infection; severe , progressive and/or
uncontrollable renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary,
cardiac, neurological disease within 12 weeks of the first dose.
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- Birmingham, Alabama