Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000433
Status:
COMPLETED
Last Update Posted:
2007-01-04
First Post:
2000-01-18
Brief Title:
Blocking Tumor Necrosis Factor in Ankylosing Spondylitis
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Study Overview
Official Title:
Anti-Tumor Necrosis Factor TNFRFc in Ankylosing Spondylitis
Status:
COMPLETED
Status Verified Date:
2003-02
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:
The Division of Rheumatology at University of California San Francisco is conducting a research study on the treatment of ankylosing spondylitis AS with a new therapy currently used for people with other forms of arthritis The drug called Enbrel or etanercept is a protein that is given twice weekly by injection underneath the skin It blocks the action of tumor necrosis factor-alpha TNF-alpha a substance that may be involved in AS rheumatoid arthritis and other inflammatory conditions We will randomly assign patients to receive either the drug or a placebo inactive treatment for 4 months The results we will monitor include morning stiffness spinal mobility activities of daily life and safety of the drug
Detailed Description:
In this Phase II clinical trial we will use tumor necrosis factor receptor p75 fusion protein TNFRFc or etanercept to treat patients with ankylosing spondylitis AS TNFRFc is an antagonist of tumor necrosis factor TNF a cytokine that researchers have shown to play a possible role in disease pathogenesis of ankylosing spondylitis rheumatoid arthritis and vasculitis as well as other inflammatory conditions
TNFRFc consists of two molecules of the extracellular portion of the p75 receptor each consisting of 235 amino acids The two receptors are fused to the Fc portion of human IgG1 which consists of 232 amino acids The gene fragments encoding the truncated TNFR and the Fc portion of human IgG1 are expressed in a Chinese hamster ovary cell line
Recent observations from animal and human studies suggest that tumor necrosis factor-alpha TNF-alpha may play a role in disease activity in AS and other seronegative spondyloarthropathies This study aims to test the efficacy of TNFRFc used in conjunction with standard medications in the treatment of AS We will give patients either 25mg of TNFRFc or placebo subcutaneously twice a week for 4 months Outcome measures will include measures of function pain morning stiffness patient global assessment and swollen joint count as well as safety measures
TNFRFc consists of two molecules of the extracellular portion of the p75 receptor each consisting of 235 amino acids The two receptors are fused to the Fc portion of human IgG1 which consists of 232 amino acids The gene fragments encoding the truncated TNFR and the Fc portion of human IgG1 are expressed in a Chinese hamster ovary cell line
Recent observations from animal and human studies suggest that tumor necrosis factor-alpha TNF-alpha may play a role in disease activity in AS and other seronegative spondyloarthropathies This study aims to test the efficacy of TNFRFc used in conjunction with standard medications in the treatment of AS We will give patients either 25mg of TNFRFc or placebo subcutaneously twice a week for 4 months Outcome measures will include measures of function pain morning stiffness patient global assessment and swollen joint count as well as safety measures
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAMS-043 | None | None | None |