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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: Completed Phase 2 study, sponsored by Ionis Pharmaceuticals.
NCT00048321 is a Phase 2 study that has completed, run by Ionis Pharmaceuticals. The registered enrollment target is 160 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00048321 record still lists
NCT00048321 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 1 intervention - of which ISIS 104838 is the first listed.
NCT00048321 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00048321's enrollment target sits among peer trials
160 422nd of 2000 higher than 1,559 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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