Back to resultsThe Pathogenesis of Inflammatory Synovitis: A Study of Early Arthritis
Primary Purpose
Arthritis, Arthritis, Reactive, Arthritis, Rheumatoid
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Arthritis focused on measuring Infection, Reactive Arthritis, Rheumatoid Arthritis, Synovial Biopsy, Synovial Fluid, Synovitis
Eligibility 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.
Sites / Locations
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001375
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT00001375
Brief Title
The Pathogenesis of Inflammatory Synovitis: A Study of Early Arthritis
Official Title
The Pathogenesis of Inflammatory Synovitis: A Study of Early Arthritis
Study Type
Observational
2. Study Status
Record Verification Date
August 1999
Overall Recruitment Status
Completed
Study Start Date
August 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Arthritis, Reactive, Arthritis, Rheumatoid, Reiter's Disease, Synovitis
Keywords
Infection, Reactive Arthritis, Rheumatoid Arthritis, Synovial Biopsy, Synovial Fluid, Synovitis
7. Study Design
Enrollment
500 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9154645
Citation
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.
Results Reference
background
PubMed Identifier
9458197
Citation
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.
Results Reference
background
PubMed Identifier
4117789
Citation
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. doi: 10.1002/art.1780150502. No abstract available.
Results Reference
background
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The Pathogenesis of Inflammatory Synovitis: A Study of Early Arthritis
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