The Effects of SCH 351125 on Mononuclear Cell Trafficking to Joints, Synovial Inflammation and Expression of Chemokines in Subjects With Rheumatoid Arthritis (Protocol No. P03653)

INTERVENTION: Subjects with active rheumatoid arthritis (RA) were enrolled in a randomized double‐blind, placebo‐controlled, parallel‐group study exposed to either SCH 351125 50 mg BID or matched placebo, in a 2:1 ratio. for 28 days. CONDITION: ; Rheumatoid arthritis ; ; PRIMARY OUTCOME: 1. To determine the effects of SCH 351125, a CCR5 receptor antagonist, on mononuclear cell migration into synovial tissue in subjects with rheumatoid arthritis;; ; 2. to evaluate the safety and tolerability of multiple‐dose administration of SCH 351125 50 mg twice‐daily in subjects with rheumatoid arthritis when administered for 28 days. SECONDARY OUTCOME: 1. To explore the effects of SCH 351125 on: ; ; a. Synovial inflammation via MRI; ; ; b. chemokine expression and concentrations in the plasma, synovial tissue and synovial fluid (mRNA expression only); ; ; c. mononuclear cell concentrations in the peripheral blood; ; ; d. clinical signs and symptoms of rheumatoid arthritis and to; ; ; e. determine the single‐dose and multiple dose pharmacokinetic profile of SCH 351125 in subjects with rheumatoid arthritis. INCLUSION CRITERIA: 1. Subjects 18 to 70 years of age, of either sex, and of any race; 2. Diagnosis of RA according to the American College of Rheumatology (ACR) criteria, for at least 6 weeks prior to entry in the study (see Appendix 6); 3. Active RA defined as: three or more tender joints, three or more swollen joints and at least one of the following three: a. duration of morning stiffness equal to or greater than 45 minutes; b. erythrocyte sedimentation rate equal to or greater than 28 mm/hr; c. or C‐reactive protein equal to or greater than 10 mg/L; 4. Functional Class I, II or III (see Appendix 6); 5. Subjects must be free of any clinically significant disease (other than rheumatoid arthritis) that would interfere with the study evaluations and/or safety; 6. Subjects must be willing to give written informed consent and able to adhere to dose and visit schedules; 7. Females must not be breast‐fe