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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001679
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: August 1999
  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

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

Resource links provided by NLM:


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
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: 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:
ClinicalTrials.gov Identifier: NCT00001679     History of Changes
Other Study ID Numbers: 980150, 98-AR-0150
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):
Immunogenetics
Joint Damage
Reactive Arthritis
Rheumatoid Arthritis
Synovium
Synovitis

Additional relevant MeSH terms:
Synovitis
Arthritis
Arthritis, Reactive
Arthritis, Rheumatoid
Arthritis, Infectious
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