Rheumatoid Arthritis
Conditions
Brief 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.
Interventions
DRUGISIS 104838
Sponsors
Ionis Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
Canada, United States
Outcome results
None listed