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The Pathogenesis of Inflammatory Synovitis: A Study of Early Arthritis - Article


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Reactive Arthritis

 




Clinical Trial: The Pathogenesis of Inflammatory Synovitis: A Study of Early Arthritis

This study has been completed.

Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: Warren G Magnuson Clinical Center (CC)

Purpose

This study will evaluate patients with inflammatory forms of arthritis within the first year of onset. The study will attempt to clarify factors that may predict disease course such as evolution into rheumatoid arthritis (RA) or other chronic inflammatory arthropathies. Synovial biopsies and synovial fluid will be obtained to search for microbial agents and other initiating and modulating factors that may be most readily distinguished early in the disease and to determine the stage of disease at which certain immunologic and hormonal changes become evident. The study will also search for genetic and other features that may be associated with specific forms of inflammatory arthropathies that might predict the subsequent clinical disease course or response to different agents used in treatment of RA, Reiter's syndrome and other types of chronic inflammatory arthropathies.

Condition
Arthritis
Arthritis, Reactive
Arthritis, Rheumatoid
Reiter's Disease
Synovitis

MedlinePlus related topics:  Arthritis;   Rheumatoid Arthritis;   Spinal Diseases;   Tailbone Disorders

Study Type: Observational
Study Design: Natural History

Further Study Details: 

Expected Total Enrollment:  500

Study start: August 24, 1994;  Study completion: June 19, 2000

This study will evaluate patients with inflammatory forms of arthritis within the first year of onset. The study will attempt to clarify factors that may predict disease course such as evolution into rheumatoid arthritis (RA) or other chronic inflammatory arthropathies. Synovial biopsies and synovial fluid will be obtained to search for microbial agents and other initiating and modulating factors that may be most readily distinguished early in the disease and to determine the stage of disease at which certain immunologic and hormonal changes become evident. The study will also search for genetic and other features that may be associated with specific forms of inflammatory arthropathies that might predict the subsequent clinical disease course or response to different agents used in treatment of RA, Reiter's syndrome and other types of chronic inflammatory arthropathies.

Eligibility

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Patients to be studied will be required to have an inflammatory arthritis of less than one year's duration.
Patients must be greater than 18 years of age.
Pregnant patients may be entered into the study, but they will not undergo percutaneous needle biopsy or joint radiographs.
No patients with known bacterial septic arthritis, crystal-induced, or degenerative arthritis.
Synovial biopsies will not be performed if patients have platelet counts less than 70,000/mm(3), other bleeding diathesis in the skin over the joint or sepsis.
Joint MRI: Patient must currently be evaluated at the NIH through protocol 94-AR-0194 or 98-AR-0150.
Joint MRI: Patient must have at least one clinically active arthritic joint that is under consideration for percutaneous needle synovial biopsy.
Joint MRI: Patients must not have the following: cardiac pacemakers, auto defibrillators, neural stimulators, aneurysm clips, metallic prostheses, cochlear (ear) implants, any implanted devices (pumps, infusion devices, etc.), metal fragments in the eye, or shrapnel injuries.
Joint MRI: Patients must not exceed the size limitations of the MRI scanner.
Joint MRI: Must not suffer from claustrophobia.
Joint MRI: Must not have had a previous anaphylactoid reaction to gadolinium-based contrast material.
Joint MRI: Must not be pregnant.

Location Information


Maryland
      National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States

More Information

Publications

Kotake S, Schumacher HR Jr, Yarboro CH, Arayssi TK, Pando JA, Kanik KS, Gourley MF, Klippel JH, Wilder RL. In vivo gene expression of type 1 and type 2 cytokines in synovial tissues from patients in early stages of rheumatoid, reactive, and undifferentiated arthritis. Proc Assoc Am Physicians. 1997 May;109(3):286-301.

Kanik KS, Hagiwara E, Yarboro CH, Schumacher HR, Wilder RL, Klinman DM. Distinct patterns of cytokine secretion characterize new onset synovitis versus chronic rheumatoid arthritis. J Rheumatol. 1998 Jan;25(1):16-22.

Schumacher HR, Kitridou RC. Synovitis of recent onset. A clinicopathologic study during the first month of disease. Arthritis Rheum. 1972 Sep-Oct;15(5):465-85. No abstract available.

Study ID Numbers:  940194; 94-AR-0194
Record last reviewed:  August 13, 1999
Last Updated:  December 11, 2002
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00001375
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 6, 2009



Page Updated: October 15, 2009
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