ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis
NCT ID: NCT00048321
Last Updated: 2022-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2002-01-01
2003-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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ISIS 104838
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Locations
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Birmingham, Alabama, United States
Paradise Valley, Arizona, United States
Los Angeles, California, United States
Rancho Cucamonga, California, United States
Fort Lauderdale, Florida, United States
Palm Harbor, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Decatur, Georgia, United States
Chicago, Illinois, United States
Wichita, Kansas, United States
Louisville, Kentucky, United States
Greenbelt, Maryland, United States
Fall River, Massachusetts, United States
Lansing, Michigan, United States
St Louis, Missouri, United States
Albuquerque, New Mexico, United States
Mayfield, Ohio, United States
Duncansville, Pennsylvania, United States
Willow Grove, Pennsylvania, United States
Amarillo, Texas, United States
Carrollton, Texas, United States
Dallas, Texas, United States
Lubbock, Texas, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Victoria, British Columbia, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Countries
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References
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Burel SA, Machemer T, Baker BF, Kwoh TJ, Paz S, Younis H, Henry SP. Early-Stage Identification and Avoidance of Antisense Oligonucleotides Causing Species-Specific Inflammatory Responses in Human Volunteer Peripheral Blood Mononuclear Cells. Nucleic Acid Ther. 2022 Dec;32(6):457-472. doi: 10.1089/nat.2022.0033. Epub 2022 Aug 17.
Related Links
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Other Identifiers
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ISIS 104838-CS7
Identifier Type: -
Identifier Source: org_study_id
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