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NCT00001679 · ClinicalTrials.gov registry record

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

A clinical trial of Arthritis, Rheumatoid and Synovitis, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

Completed
Registry status
250
Enrollment target
1
Study location

NCT00001679 is a study of Arthritis, Rheumatoid and Synovitis that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 250 participants, below the 632-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00001679, a study of Arthritis, Rheumatoid and Synovitis, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

COMPLETED
Registry status
250 participants
Enrollment target
1
Study location

Study 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.

Study Locations (1)

Maryland

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

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 1998-08
Est. Completion 2000-06

What the Registry Record Tells You About NCT00001679

The ClinicalTrials.gov registry entry for NCT00001679 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 632-participant average among 27 other Arthritis, Rheumatoid trials with a reported enrollment target (60% lower). The listed sponsor is National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Arthritis, Rheumatoid appearing as the primary indexed condition, and to 0 interventions.

NCT00001679 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.

Frequently Asked Questions

What is clinical trial NCT00001679 about?

NCT00001679 is a clinical study titled "Prognostic Indicators and Determinants of the 2-5 Year Outcome in a Cohort of Early Synovitis Patients". 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...

What is the current status of trial NCT00001679?

This trial is currently completed. The enrollment target is 250 participants. The study started on 1998-08. Estimated completion is 2000-06.

What conditions does trial NCT00001679 study?

This clinical trial studies the following conditions: Arthritis, Rheumatoid, Synovitis, Arthritis, Reactive.

Who is sponsoring clinical trial NCT00001679?

This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00001679 being conducted?

This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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