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

Primary Purpose

Arthritis, Reactive, Arthritis, Rheumatoid, Synovitis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Arthritis, Reactive focused on measuring Immunogenetics, Joint Damage, Reactive Arthritis, Rheumatoid Arthritis, Synovium, Synovitis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00001679
Brief Title
Prognostic Indicators and Determinants of the 2-5 Year Outcome in a Cohort of Early Synovitis Patients
Official Title
Prognostic Indicators and Determinants of the 2-5 Year Outcome in a Cohort of Early Synovitis Patients
Study Type
Observational

2. Study Status

Record Verification Date
August 1999
Overall Recruitment Status
Completed
Study Start Date
August 1998 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Reactive, Arthritis, Rheumatoid, Synovitis
Keywords
Immunogenetics, Joint Damage, Reactive Arthritis, Rheumatoid Arthritis, Synovium, Synovitis

7. Study Design

Enrollment
250 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
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
9088522
Citation
Emery P, Symmons DP. What is early rheumatoid arthritis?: definition and diagnosis. Baillieres Clin Rheumatol. 1997 Feb;11(1):13-26. doi: 10.1016/s0950-3579(97)80030-1.
Results Reference
background
PubMed Identifier
8856609
Citation
Harrison BJ, Symmons DP, Brennan P, Bankhead CR, Barrett EM, Scott DG, Silman AJ. Inflammatory polyarthritis in the community is not a benign disease: predicting functional disability one year after presentation. J Rheumatol. 1996 Aug;23(8):1326-31.
Results Reference
background
PubMed Identifier
7774101
Citation
Hulsemann JL, Zeidler H. Undifferentiated arthritis in an early synovitis out-patient clinic. Clin Exp Rheumatol. 1995 Jan-Feb;13(1):37-43.
Results Reference
background

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

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