ISIS 104838-CS7, A Double-Blind, Placebo-Controlled, Randomized Trial of the Safety, Efficacy and Pharmacokinetic Profile of ISIS 104838 (TNF-Alpha Antisense Oligonucleotide) Subcutaneous Injections in Active Rheumatoid Arthritis Patients

Inclusion Criteria

Inclusion Criteria

1. Age >/= 18 years.

2. Rheumatoid arthritis for >/= 6 months.

3. Active disease as defined by >/= 6 swollen and >/= 9 tender joints, AND an abnormal
C-reactive protein or Westergren Erythrocyte Sedimentation Rate lab test, OR Morning
Stiffness >/= 1 hour.

4. Use of at least one DMARD, and ability to discontinue any current DMARD.

Exclusion Criteria

1. Onset of rheumatoid arthritis before the 16th birthday.

2. Wheelchair or bed-bound functional level.

3. No previous infliximab or etanercept treatment, or investigational therapy (not
placebo) with other TNF-alpha inhibitors.

4. Prednisone > 10 mg per day or more than one nonsteroidal anti-inflammatory drug.

5. Patients with an active infection, a history of tuberculosis, multiple sclerosis,
other poorly controlled medical illness, or a malignancy within the last 5 years.

6. Patients who require intravenous heparin therapy or with a history of a bleeding
problem.