ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

ISIS 104838 is an antisense oligonucleotide drug that reduces the production of a specific protein called tumor necrosis factor (TNF-alpha), a substance that contributes to joint pain and swelling in rheumatoid arthritis. ISIS 104838 works by blocking TNF-alpha messenger RNA, the "instruction" molecule that is required for the production of TNF-alpha protein. This trial will assess the safety and efficacy of ISIS 1048383 by subcutaneous injection, administered by 3 different dosing regimens for 3 months, versus placebo. Approximately 160 TNF-alpha inhibitor-naïve rheumatoid arthritis patients will be evaluated at 32 sites in the U.S. and Canada.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.

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.