Maraviroc in Rheumatoid Arthritis

• Drug: Maraviroc
  300 mg (2- 150 mg tablets) are administered by mouth twice a day (BID) for 12 weeks.
• Drug: Maraviroc Placebo
  Placebo tablets to match active drug. Two tablets are administered by mouth twice a day (BID) for 12 weeks.

• Placebo Comparator: 2
  Intervention: Drug: Maraviroc Placebo
• Experimental: 1
  This study was divided into two components: safety/pharmacokinetic (PK) and proof-of-concept (POC). In the safety/PK component either 150 mg or 300 mg tablets of maraviroc was administered twice a day (BID) to 16 rheumatoid arthritis subjects for 4 weeks.
  Intervention: Drug: Maraviroc

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 failure
• 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.