Division of Rheumatology Website - Clinical Trials

Name of Study:	Interleukin-1 Receptor Antagonist (IL-1ra) versus Acetaminophen for Treatment of Osteoarthritis of the Hip or Knee
Principal Investigator:	H. Ralph Schumacher, Jr., MD
Sponsor:	Amgen
Coordinator:	Jan Dinnella 215.823.5800 ext. 2560 jdinnell@mail.med.upenn.edu
Short Description of the Study/Study Compound:	The purpose of this study is to compare IL-1ra with acetaminophen in the treatment of osteoarthritis of the hip or knee. Patients will take medication and give themselves an injection daily for 16 weeks. For one 8-week period they will receive acetaminophen and a placebo injection. For the other 8-week period they will receive an IL-1ra injection. There will be a 1-week "washout" period between these two treatment sessions to cleanse the body of the previous medication. Neither the patients nor the doctors will know when they are receiving acetaminophen and when they are receiving IL-1ra. Patients will come to the doctor's office 7 times during the study to be checked and to fill out questionnaires about how they are feeling. Participants will receive $50.00 at visit 4 and $100.00 at the final visit. IL-1ra is currently used for the treatment of rheumatoid arthritis but has not been formally studied for the treatment of osteoarthritis.
Inclusion:	40 years of age or older Osteoarthritis of the hip or knee measurable by x-ray with moderate to severe pain Women must not intend to become pregnant during the study period
Exclusion:	History of intolerance to acetaminophen Already has taken IL-1ra Been in a research study involving receiving an investigational drug or using an investigational device within the last 30 days Pregnant or nursing Bleeding disorder Current active infection Inflammatory rheumatic disease such as rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis Uncontrolled high blood pressure Joint surgery planned for during the study period Taking more than 325 mg per day of aspirin, anticoagulants, or lithium Narcotic or alcohol abuse within 12 months of entering the study Abnormal liver or renal function Know hypersensitivity to E. coli-derived proteins or components of the IL-1ra formulation Unable to give a daily intraarticular injection (training provided)