ISIS 104838, an Inhibitor of Tumor Necrosis Factor, for Active Rheumatoid Arthritis
Public ClinicalTrials.gov record NCT00048321. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00048321
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 160 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2001
- Primary completion
- Jan 31, 2003
- Completion
- Jan 31, 2003
- Last update posted
- Dec 4, 2022
2002 – 2003
United States locations
- U.S. sites
- 26
- U.S. states
- 18
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | — | — |
| Not listed | Paradise Valley | Arizona | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | Rancho Cucamonga | California | — | — |
| Not listed | Fort Lauderdale | Florida | — | — |
| Not listed | Palm Harbor | Florida | — | — |
| Not listed | Sarasota | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Decatur | Georgia | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Wichita | Kansas | — | — |
| Not listed | Louisville | Kentucky | — | — |
| Not listed | Greenbelt | Maryland | — | — |
| Not listed | Fall River | Massachusetts | — | — |
| Not listed | Lansing | Michigan | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Albuquerque | New Mexico | — | — |
| Not listed | Mayfield | Ohio | — | — |
| Not listed | Duncansville | Pennsylvania | — | — |
| Not listed | Willow Grove | Pennsylvania | — | — |
| Not listed | Amarillo | Texas | — | — |
| Not listed | Carrollton | Texas | — | — |
| Not listed | Dallas | Texas | — | — |
| Not listed | Lubbock | Texas | — | — |
| Not listed | Richmond | Virginia | — | — |
| Not listed | Seattle | Washington | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00048321, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 4, 2022 · Synced Sep 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00048321 live on ClinicalTrials.gov.