Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001679
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Prognostic Indicators and Determinants of the 2-5 Year Outcome in a Cohort of Early Synovitis Patients
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Prognostic Indicators and Determinants of the 2-5 Year Outcome in a Cohort of Early Synovitis Patients
Status:
COMPLETED
Status Verified Date:
1999-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 98-AR-0150 | None | None | None |