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ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis Clinical research trials and ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis. ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis clinical trial. Subjects typically recieve the finest healthcare available for their ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis  ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis
ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis
For Condition: Rheumatoid Arthritis
Status: No longer recruiting
Sponsor(s): Isis Pharmaceuticals ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional,Treatment,Randomized,Double-Blind,Placebo Control,Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 160
Location and Contact Information:
Additional Information:
Study ID Numbers: ISIS 104838-CS7;
Study Start Date: January 2002
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00048321
Other Rheumatoid Arthritis Studies:
1. Relaxation Response Training for the Treatment of Rheumatoid Arthritis
2. A Safety Study of Escalating Doses of PRO70769 for Subjects with Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant Methotrexate
3. Lung Disease Associated with Rheumatoid Arthritis
4. ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis
5. Safety Study for Remicade
Related Studies:
Other Rheumatoid Arthritis Clinical Trials
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ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis
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