RHEUMATOID ARTHRITIS

RESEARCH STUDY

Bone and Joint Hospital Research Department, in conjunction with McBride Clinic Rheumatologists, is recruiting subjects with active rheumatoid arthritis (RA) who have an inadequate response to methotrexate therapy.  The purpose of the research study is to determine the efficacy and safety of single or dual-infusion doses of an investigational drug  compared to placebo.

You may be eligible for participation if you meet these criteria:

v     Active RA that is inadequately controlled by methotrexate

v     Age 18 years or older

v     Swollen and tender joints at the Screening and Baseline study

visits

v     Specific laboratory test results that indicate continued

inflammation

v     Inadequate response to methotrexate when taken at doses of 7.5

to 25 mg/week for at least 12 weeks

Once a subject has been screened and determined eligible for study participation, the trial consists of two distinct periods: the double-blind treatment period (receive investigational drug and/or placebo) and the study-extension period (receive investigational drug). 

The duration of the double blind treatment period is 48 weeks during which subjects may receive two courses of study treatment; each course consists of two infusions. During the first phase of the double blind period, some subjects will receive active study drug and some will receive placebo. During the second phase, all subjects will receive active drug, but at different doses. You are required to continue your weekly dose of methotrexate throughout the 48 week period.

At the end of the double blind treatment period, you may be eligible to receive multiple courses of an open label study drug administered as a single infusion.

Eligible subjects will receive study medication and study-related treatment at no charge, as well as a stipend for visits completed.

For additional information, please call Lori at the Bone and Joint Hospital Research Department, at 405-552-9466, or lori_patton@ssmhc.com.

For more information on our Clinical Research Trials, go to http://centerwatch.com/professional/pro269.html