Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001291
Status:
COMPLETED
Last Update Posted:
2008-03-05
First Post:
1999-11-03
Brief Title:
Genetic and Immune Studies of Rheumatoid Arthritis and Related Conditions
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Investigations of Blood Synovial Tissue and Synovial Fluids From Patients With Rheumatoid Arthritis and Related Conditions
Status:
COMPLETED
Status Verified Date:
1999-12
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:
This protocol will examine blood synovial fluid and synovial tissue from patients with rheumatoid arthritis and other chronic inflammatory joint diseases to study genetic and immunologic factors involved in the cause development and progression of these conditions Synovial fluid is the lubricating fluid in joints The synovial membrane is a delicate tissue lining the inner surface of joints which in arthritic conditions thickens and becomes infiltrated with various types of cells
Patients with rheumatoid arthritis and certain patients with other forms of arthritis may be eligible for this study Those enrolled will be followed periodically for follow-up and disease evaluation They may undergo the following procedures
1 Synovial fluid aspiration when medically indicated for example for joint swelling and inflammation For this procedure an area of skin around the joint is numbed with an anesthetic and a needle is inserted into the joint to withdraw a small fluid sample
2 Periodic blood sampling not to exceed 450 milliliters 15 ounces during any 6-week period for genetic studies of rheumatoid arthritis The samples are usually taken at the same times that synovial fluid is withdrawn
3 Synovial tissues collected by needle biopsy or during surgical procedures for arthroscopy examination of the interior of the joint and repair of the joint or total joint replacement For the needle biopsy the skin over the biopsy site is washed and anesthetized A needle is inserted and fluid is aspirated The biopsy needle is then inserted through the outer needle and a tissue sample is suctioned
Patients who qualify for other research studies may be invited to participate
Patients with rheumatoid arthritis and certain patients with other forms of arthritis may be eligible for this study Those enrolled will be followed periodically for follow-up and disease evaluation They may undergo the following procedures
1 Synovial fluid aspiration when medically indicated for example for joint swelling and inflammation For this procedure an area of skin around the joint is numbed with an anesthetic and a needle is inserted into the joint to withdraw a small fluid sample
2 Periodic blood sampling not to exceed 450 milliliters 15 ounces during any 6-week period for genetic studies of rheumatoid arthritis The samples are usually taken at the same times that synovial fluid is withdrawn
3 Synovial tissues collected by needle biopsy or during surgical procedures for arthroscopy examination of the interior of the joint and repair of the joint or total joint replacement For the needle biopsy the skin over the biopsy site is washed and anesthetized A needle is inserted and fluid is aspirated The biopsy needle is then inserted through the outer needle and a tissue sample is suctioned
Patients who qualify for other research studies may be invited to participate
Detailed Description:
Blood synovial fluids andor synovial tissues will be obtained from patients with rheumatoid arthritis and related chronic inflammatory arthritides The synovial tissues will be obtained by one of the following methods a needle biopsy or b at the time of a total joint replacement or a therapeutic arthroscopic procedure These materials will be utilized for laboratory studies of etiopathogenetic mechanisms of rheumatoid arthritis and related autoimmune joint diseases
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 |
|---|---|---|---|
| 92-AR-0065 | None | None | None |