Genetic and Immune Studies of Rheumatoid Arthritis and Related Conditions

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001291
First received: November 3, 1999
Last updated: March 4, 2008
Last verified: December 1999

November 3, 1999
March 4, 2008
December 1991
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00001291 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Genetic and Immune Studies of Rheumatoid Arthritis and Related Conditions
Investigations of Blood, Synovial Tissue and Synovial Fluids From Patients With Rheumatoid Arthritis and Related Conditions

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 The samples are usually taken at the same times that synovial fluid is withdrawn.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.

Blood, synovial fluids and/or 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.

Observational
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
  • Arthritis, Psoriatic
  • Autoimmune Diseases
  • Joint Diseases
  • Osteoarthritis
  • Rheumatoid Arthritis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
January 2001
Not Provided

Patients with rheumatoid arthritis, particularly new onset disease, but certain patients with other forms of arthritis will also be included.

Significantly swollen or tender knee or significantly swollen shoulders, elbows, wrists, ankles, olecranon bursa or even smaller joints.

Synovial tissue specimens will not be obtained from patients when any of the following conditions are present: abnormal bleeding or clotting tests, platelet count less than 100,000, or sepsis.

Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001291
920065, 92-AR-0065
Not Provided
Not Provided
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Not Provided
Not Provided
National Institutes of Health Clinical Center (CC)
December 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP