- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001291
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:
- 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.
- 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 The samples are usually taken at the same times that synovial fluid is withdrawn.
- 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.
Study Overview
Status
Detailed Description
Study Type
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Lafyatis R, Remmers EF, Roberts AB, Yocum DE, Sporn MB, Wilder RL. Anchorage-independent growth of synoviocytes from arthritic and normal joints. Stimulation by exogenous platelet-derived growth factor and inhibition by transforming growth factor-beta and retinoids. J Clin Invest. 1989 Apr;83(4):1267-76. doi: 10.1172/JCI114011.
- Kumkumian GK, Lafyatis R, Remmers EF, Case JP, Kim SJ, Wilder RL. Platelet-derived growth factor and IL-1 interactions in rheumatoid arthritis. Regulation of synoviocyte proliferation, prostaglandin production, and collagenase transcription. J Immunol. 1989 Aug 1;143(3):833-7.
- Lafyatis R, Thompson NL, Remmers EF, Flanders KC, Roche NS, Kim SJ, Case JP, Sporn MB, Roberts AB, Wilder RL. Transforming growth factor-beta production by synovial tissues from rheumatoid patients and streptococcal cell wall arthritic rats. Studies on secretion by synovial fibroblast-like cells and immunohistologic localization. J Immunol. 1989 Aug 15;143(4):1142-8.
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Immune System Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Skin Diseases, Papulosquamous
- Spinal Diseases
- Bone Diseases
- Spondylarthropathies
- Spondylarthritis
- Spondylitis
- Psoriasis
- Arthritis
- Arthritis, Rheumatoid
- Osteoarthritis
- Joint Diseases
- Arthritis, Psoriatic
- Autoimmune Diseases
Other Study ID Numbers
- 920065
- 92-AR-0065
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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