Drugs / ISIS 104838
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT00048321 | Jan 2002 → Feb 2003 | rheumatoid arthritis | Ionis Pharmaceuticals, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2004-01-05 | Ionis Pharmaceuticals | Results Isis Pharmaceuticals Reports Positive Data from Phase 2 Trial Of ISIS 104838 in Rheumatoid Arthritis ionis.com ↗
Isis Pharmaceuticals, Inc. (Nasdaq: ISIS) today reported data from a Phase 2 clinical trial which demonstrate that ISIS 104838, an antisense TNF-alpha inhibitor, produced a statistically significant disease response in patients with rheumatoid arthritis (RA). |
| 2003-10-27 | Ionis Pharmaceuticals | Results Isis Pharmaceuticals Updates Positive Clinical Data on Multiple Antisense Drugs ionis.com ↗
Final results from Phase 2 studies of ISIS 104838 in patients with rheumatoid arthritis and ISIS 14803 for the treatment of the hepatitis C virus (HCV) were presented last weekend at the 67th Annual Meeting of the American College of Rheumatology (ACR) and the 54th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), respectively. |
| 2003-09-18 | Ionis Pharmaceuticals | Results Second-Generation Antisense Drug ISIS 104838 Reduces TNF-alpha In Rheumatoid Arthritis Patients ionis.com ↗
ISIS 104838 reduced TNF-alpha mRNA levels in synovial tissue and stabilized levels of TNF-alpha in blood, according to interim results of a Phase 2a clinical trial in rheumatoid arthritis (RA) patients receiving 300 mg of the second-generation antisense drug. |
| 2002-11-12 | Ionis Pharmaceuticals | Results New Data on Capsule Form of ISIS 104838 Demonstrate Antisense Drugs Can Be Administered Orally Orasense Joint Venture Makes Fundamental Advance in Antisense Technology ionis.com ↗
In a Phase I study, a proprietary solid oral formulation of ISIS 104838 achieved drug plasma concentrations sufficient to support further clinical development of oral antisense drugs. |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2004-01-05 | Ionis Pharmaceuticals | Webcast Alert: Isis Pharmaceuticals Announces Phase 2 Results of ISIS 104838 in Rheumatoid Arthritis ionis.com ↗ |
| 2004-01-05 | Ionis Pharmaceuticals | Isis Pharmaceuticals Reports Positive Data from Phase 2 Trial Of ISIS 104838 in Rheumatoid Arthritis ionis.com ↗ |
| 2003-10-27 | Ionis Pharmaceuticals | Isis Pharmaceuticals Updates Positive Clinical Data on Multiple Antisense Drugs ionis.com ↗ |
| 2003-09-18 | Ionis Pharmaceuticals | Second-Generation Antisense Drug ISIS 104838 Reduces TNF-alpha In Rheumatoid Arthritis Patients ionis.com ↗ |
| 2002-11-12 | Ionis Pharmaceuticals | New Data on Capsule Form of ISIS 104838 Demonstrate Antisense Drugs Can Be Administered Orally Orasense Joint Venture Makes Fundamental Advance in Antisense Technology ionis.com ↗ |
| 2002-03-13 | Ionis Pharmaceuticals | Isis Pharmaceuticals Initiates Phase II Clinical Trial of ISIS 104838, A TNF-Alpha Inhibitor, in Rheumatoid Arthritis ionis.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ISIS 104838 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00048321 ↗ |
| Action | Inhibit | “reduces the production of a specific protein called tumor necrosis factor (TNF-alpha)” NCT00048321 ↗ |
| Modality | Antisense oligonucleotide | “ISIS 104838 is an antisense oligonucleotide drug” NCT00048321 ↗ |
| Route | Subcutaneous | “by subcutaneous injection” NCT00048321 ↗ |