Trial record 1 of 3923 for:    "Arthritis"
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The Pathogenesis of Inflammatory Synovitis: A Study of Early Arthritis

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001375
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: August 1999
  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

Study Type: Observational
Official Title: The Pathogenesis of Inflammatory Synovitis: A Study of Early Arthritis

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 500
Study Start Date: August 1994
Estimated Study Completion Date: June 2000
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001375

Locations
United States, Maryland
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00001375     History of Changes
Other Study ID Numbers: 940194, 94-AR-0194
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Infection
Reactive Arthritis
Rheumatoid Arthritis
Synovial Biopsy
Synovial Fluid
Synovitis

Additional relevant MeSH terms:
Arthritis
Arthritis, Reactive
Arthritis, Rheumatoid
Arthritis, Infectious
Synovitis
Autoimmune Diseases
Bone Diseases
Connective Tissue Diseases
Immune System Diseases
Infection
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis

ClinicalTrials.gov processed this record on October 23, 2014