Phase 1 Trial of Type II Collagen (CII) APL A12 in Rheumatoid Arthritis Patients

Inclusion Criteria:

Patients must meet the following criteria for participation in the study.

• Male or female; age > 18 years.
• American College of Rheumatology (ACR) 1988 revised criteria for rheumatoid arthritis.
• Onset of disease age 16 or older.
• Onset of disease at least 3 months prior to enrollment.
• RA patients ages 18-85 with RA of 3 month duration which in the opinion of the examining rheumatologist is "clinically stable" and will likely not require adjustment of doses of Disease-modifying antirheumatic drugs (DMARDS), NSAIDS, prednisone, anti-tumor necrosis factor (anti-TNF) alpha therapies for the 16 weeks of the treatment phase of the study.
• Patients must agree to discontinue all "herbal remedies" as described in this protocol.
• Women of childbearing age will be advised to use effective means of contraception for the treatment phase of the trial and for 90 days thereafter. They must have a negative urine pregnancy test at the randomization visit. (Required by the FDA.)
• Men will be advised to use effective means of contraception for the treatment phase of the trial and for 90 days thereafter. (Required by the FDA.)
• Crohn's Disease Activity Index (CDAI) less than or equal to 30 at the baseline visit.
• Patients with a past history of malignant neoplasm will be eligible if they are 1 or greater years with no recurrence of malignant neoplasm.

Exclusion Criteria:

• Inability to render an informed consent in accordance with institutional guidelines.
• Participation in another clinical research study involving the evaluation of another investigational drug within 90 days of entry into this study.
• RA patients on >7.5 mg prednisone a day.
• RA patients with intra-articular corticosteroid injections during the previous 30 days.
• Concurrent serious medical condition which in the opinion of the investigator makes the patient inappropriate for the study. Hepatitis B abd/or C patients with inactive disease (as determined by PI) will be enrolled.
• Positive urine pregnancy test
• Age 85 years or greater.
• Use of "fish oil" within the previous 4 weeks of the baseline visit.
• Therapy consisting of auranofin or cyclophosphamide (all other DMARDs are allowed).
• Previous autologous or heterologous stem cell transplantation.
• Active malignant neoplasm or past treatment for malignant neoplasm 1 year from screening visit.
• Use of oral CII within the past 1 year. (Since oral tolerance is short-lived, we will permit patients in the study who have been off oral CII for > 1 year)
• Diabetes requiring insulin or on oral medications must be well managed at baseline. Adjustment of insulin or on oral medications will be allowed during the study.
• Serum creatinine 2.0 mcg/dL.
• An 1(II) IFN value <100% of the PBS IFN value within 1 month or less prior to the baseline and less than 25% reduction in APL A12 + 1(II) IFN from 1(II) IFN concentration.
• CDAI > 30 at the baseline visit.