Rheumatoid Arthritis Clinical Trial
Official title:
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
Verified date | October 2007 |
Source | Ionis Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | February 1, 2003 |
Est. primary completion date | February 1, 2003 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Ionis Pharmaceuticals, Inc. |
United States, Canada,
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