Genetic and Immune Studies of Rheumatoid Arthritis and Related Conditions
|First Received Date ICMJE||November 3, 1999|
|Last Updated Date||March 4, 2008|
|Start Date ICMJE||December 1991|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001291 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Genetic and Immune Studies of Rheumatoid Arthritis and Related Conditions|
|Official Title ICMJE||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:
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||January 2001|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00001291|
|Other Study ID Numbers ICMJE||920065, 92-AR-0065|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||December 1999|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP