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NCT00048321 · ClinicalTrials.gov registry record · Phase 2
ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis
A Phase 2 study, sponsored by Ionis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
NCT00048321 is a Phase 2 study that has completed, run by Ionis Pharmaceuticals. The registered enrollment target is 160 participants.
The verdict
NCT00048321, a Phase 2 study, has completed, sponsored by Ionis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
Study 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
- DRUG ISIS 104838
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2002-01-01 |
| Est. Completion | 2003-02-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00048321
The ClinicalTrials.gov registry entry for NCT00048321 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ionis Pharmaceuticals, which has 76 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ISIS 104838 is the first listed.
NCT00048321 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00048321 about?
NCT00048321 is a clinical study titled "ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis". 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" molec...
What is the current status of trial NCT00048321?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2002-01-01. Estimated completion is 2003-02-01.
What interventions are being tested in trial NCT00048321?
The interventions under investigation include: ISIS 104838 (DRUG).
Who is sponsoring clinical trial NCT00048321?
This trial is sponsored by Ionis Pharmaceuticals, which has 76 total clinical trials registered on ClinicalTrials.gov.
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