ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis
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
1 other identifier
interventional
160
2 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 rheumatoid-arthritis
Started Jan 2002
Shorter than P25 for phase_2 rheumatoid-arthritis
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 29, 2002
CompletedFirst Posted
Study publicly available on registry
October 31, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2003
CompletedDecember 5, 2022
October 1, 2007
1.1 years
October 29, 2002
December 1, 2022
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- Age \>/= 18 years.
- Rheumatoid arthritis for \>/= 6 months.
- 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.
- Use of at least one DMARD, and ability to discontinue any current DMARD.
You may not qualify if:
- Onset of rheumatoid arthritis before the 16th birthday.
- Wheelchair or bed-bound functional level.
- No previous infliximab or etanercept treatment, or investigational therapy (not placebo) with other TNF-alpha inhibitors.
- Prednisone \> 10 mg per day or more than one nonsteroidal anti-inflammatory drug.
- Patients with an active infection, a history of tuberculosis, multiple sclerosis, other poorly controlled medical illness, or a malignancy within the last 5 years.
- Patients who require intravenous heparin therapy or with a history of a bleeding problem.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Paradise Valley, Arizona, United States
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Los Angeles, California, United States
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Rancho Cucamonga, California, United States
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Fort Lauderdale, Florida, United States
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Palm Harbor, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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Decatur, Georgia, United States
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Chicago, Illinois, United States
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Wichita, Kansas, United States
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Louisville, Kentucky, United States
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Greenbelt, Maryland, United States
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Fall River, Massachusetts, United States
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Lansing, Michigan, United States
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St Louis, Missouri, United States
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Albuquerque, New Mexico, United States
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Mayfield, Ohio, United States
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Duncansville, Pennsylvania, United States
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Willow Grove, Pennsylvania, United States
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Amarillo, Texas, United States
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Carrollton, Texas, United States
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Dallas, Texas, United States
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Lubbock, Texas, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Victoria, British Columbia, Canada
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Ottawa, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Related Publications (1)
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.
PMID: 35976085DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 29, 2002
First Posted
October 31, 2002
Study Start
January 1, 2002
Primary Completion
February 1, 2003
Study Completion
February 1, 2003
Last Updated
December 5, 2022
Record last verified: 2007-10