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Prognostic Indicators and Determinants of the 2-5 Year Outcome in a Cohort of Early Synovitis Patients

This study has been completed.

Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001679
  Purpose

This study will evaluate the 2-5 year outcome of a cohort of 250 patients with early synovitis, who were recruited into protocol 94-AR-0194 (The Pathogenesis of Inflammatory Synovitis: A Study of Early Arthritis). Clinical, radiographic, and functional outcome parameters, particularly those relating to articular damage and functional loss, will be evaluated and related back to clinical, serologic, immunogenetic, and pathologic variables identified at the onset of the arthropathy. A model will be generated which incorporates and weighs the variables in order to determine diagnostic and prognostic markers in the early stages of arthritis. Synovial tissue samples have been obtained from the entire cohort at the initial visit of protocol 94-AR-0194. Studies of these biopsies have so far demonstrated evidence for the presence of infectious agents in a proportion of the samples, and have generated information regarding the cytokine profiles in the early stages of synovitis. In an attempt to further define the pathogenetic mechanisms of synovitis longitudinally, biopsies will be repeated on selected subsets of the cohort. Specific questions to be answered relate to the persistence of microbial agents in the synovium, and to the evolution of cellular and molecular mechanisms which mediate the invasive, destructive potential of the synovial lesion. It is anticipated that these studies should prove valuable to clinicians who are attempting to stratify patients for therapeutic strategies, early in their disease course. They should also prove valuable in enhancing the understanding of the pathogenetic mechanisms of synovitis.


Condition
Arthritis, Reactive
Arthritis, Rheumatoid
Synovitis

MedlinePlus related topics:   Rheumatoid Arthritis   

U.S. FDA Resources

Study Type:   Observational
Official Title:   Prognostic Indicators and Determinants of the 2-5 Year Outcome in a Cohort of Early Synovitis Patients

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

Estimated Enrollment:   250
Study Start Date:   August 1998
Estimated Study Completion Date:   June 2000

Detailed Description:

This study will evaluate the 2-5 year outcome of a cohort of 250 patients with early synovitis, who were recruited into protocol 94-AR-0194 (The Pathogenesis of Inflammatory Synovitis: A Study of Early Arthritis). Clinical, radiographic, and functional outcome parameters, particularly those relating to articular damage and functional loss, will be evaluated and related back to clinical, serologic, immunogenetic, and pathologic variables identified at the onset of the arthropathy. A model will be generated which incorporates and weighs the variables in order to determine diagnostic and prognostic markers in the early stages of arthritis. Synovial tissue samples have been obtained from the entire cohort at the initial visit of protocol 94-AR-0194. Studies of these biopsies have so far demonstrated evidence for the presence of infectious agents in a proportion of the samples, and have generated information regarding the cytokine profiles in the early stages of synovitis. In an attempt to further define the pathogenetic mechanisms of synovitis longitudinally, biopsies will be repeated on selected subsets of the cohort. Specific questions to be answered relate to the persistence of microbial agents in the synovium, and to the evolution of cellular and molecular mechanisms which mediate the invasive, destructive potential of the synovial lesion. It is anticipated that these studies should prove valuable to clinicians who are attempting to stratify patients for therapeutic strategies, early in their disease course. They should also prove valuable in enhancing the understanding of the pathogenetic mechanisms of synovitis.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

All patients who have been recruited into, and completed, the 1 year follow up of protocol 94-AR-0194.

FOR ENTRY ONTO 98-AR-0150 JOINT MRI:

Patients currently being evaluated at the NIH through Protocol 94-AR-0194 or 98-AR-1050.

Must have at least one clinically active arthritic joint that is under consideration for percutaneous needle synovial biopsy.

No patients who have any of the following: cardiac pacemakers, auto defribrillators, neural stimulators, aneurysm clips, metallic prostheses, cochlear (ear) implants, any implanted devices (pumps, infusion devices, etc.), metal fragments in the eye, or shrapnel injuries.

No patients who exceed the size limitations of the MRI scanner.

No patients who suffer from claustrophobia.

No patients who have had a previous anaphylactoid reaction to gadolinium-based contrast material.

No patients who are currently pregnant.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001679

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:

Study ID Numbers:   980150, 98-AR-0150
First Received:   November 3, 1999
Last Updated:   March 3, 2008
ClinicalTrials.gov Identifier:   NCT00001679
Health Authority:   United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Immunogenetics  
Joint Damage  
Reactive Arthritis  
Rheumatoid Arthritis
Synovium
Synovitis

Study placed in the following topic categories:
Spinal Diseases
Autoimmune Diseases
Spondylarthropathy
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Arthritis, Infectious
Bone Diseases
Arthritis, Reactive
Musculoskeletal Diseases
Arthritis
Reiter's Syndrome
Connective Tissue Diseases
Synovitis
Spondylarthritis
Spondylarthropathies

Additional relevant MeSH terms:
Immune System Diseases
Infection

ClinicalTrials.gov processed this record on October 31, 2008




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