Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048321
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2002-10-29
Brief Title:
ISIS 104838 an Inhibitor of Tumor Necrosis Factor for Active Rheumatoid Arthritis
Sponsor:
Ionis Pharmaceuticals Inc
Organization:
Ionis Pharmaceuticals Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 US and Canada
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None