Open Label Multicenter Induction of CII Tolerance in Patients With Rheumatoid Arthritis

Note: accrual into this trial has been discontinued, but patients previously enrolled are still being followed.

• Clinically stable RA and unlikely to require adjustment of doses of DMARDs, NSAIDs, prednisone, or anti-TNFα therapies for the treatment phase of the study
• Meets American College of Rheumatology (ACR) 1988 revised criteria for RA
• Onset of disease at age 16 or older
• Onset of disease at least 3 months prior to enrollment
• PBMC - IFNγ - α1(II)/PBS stimulation index greater than or equal to 1.5 in 6 months prior to baseline visit
• Agree to discontinue herbal remedies described in this protocol
• Agree to use acceptable forms of contraception

• Participation in another clinical research study involving the evaluation of another investigational drug within 90 days prior to study entry
• Currently taking greater than 7.5 mg prednisone daily
• Intra-articular corticosteroid injections within 30 days prior to study entry
• Concurrent serious medical condition which, in the opinion of the investigator, makes the patient inappropriate for the study
• Pregnancy
• Beef allergy
• Use of fish oil within 4 weeks of study entry
• Previous use of auranofin or cyclophosphamide (all other DMARDs are allowed)
• Previous autologous or heterologous stem cell transplantation
• Active malignancy or past treatment consisting of antineoplastic drugs or total lymphoid irradiation
• Intolerance to citrus juices or colorless carbonated beverages