Completed

The Pathogenesis of Inflammatory Synovitis: A Study of Early Arthritis

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What is being collected

Data Collection

Who is being recruted

Post-Infectious Disorders+20

+ Arthritis, Infectious

+ Autoimmune Diseases

See all eligibility criteria
How is the trial designed

Observational
Study Start: August 1994
See protocol details

Summary

Principal SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 1994

Actual date on which the first participant was enrolled.

This study will evaluate patients with inflammatory forms of arthritis within the first year of onset. The study will attempt to clarify factors that may predict disease course such as evolution into rheumatoid arthritis (RA) or other chronic inflammatory arthropathies. Synovial biopsies and synovial fluid will be obtained to search for microbial agents and other initiating and modulating factors that may be most readily distinguished early in the disease and to determine the stage of disease at which certain immunologic and hormonal changes become evident. The study will also search for genetic and other features that may be associated with specific forms of inflammatory arthropathies that might predict the subsequent clinical disease course or response to different agents used in treatment of RA, Reiter's syndrome and other types of chronic inflammatory arthropathies.

NCT00001375
Principal SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last updated: March 4, 2008
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Post-Infectious DisordersArthritis, InfectiousAutoimmune DiseasesBone DiseasesChronic DiseaseConnective Tissue DiseasesImmune System DiseasesJoint DiseasesMusculoskeletal DiseasesPathologic ProcessesRheumatic DiseasesSpinal DiseasesSpondylitisPathological Conditions, Signs and SymptomsSkin and Connective Tissue DiseasesDisease AttributesSpondylarthritisSpondylarthropathiesArthritisArthritis, RheumatoidInfectionsSynovitisArthritis, Reactive

Criteria

Patients to be studied will be required to have an inflammatory arthritis of less than one year's duration. Patients must be greater than 18 years of age. Pregnant patients may be entered into the study, but they will not undergo percutaneous needle biopsy or joint radiographs. No patients with known bacterial septic arthritis, crystal-induced, or degenerative arthritis. Synovial biopsies will not be performed if patients have platelet counts less than 70,000/mm(3), other bleeding diathesis in the skin over the joint or sepsis. Joint MRI: Patient must currently be evaluated at the NIH through protocol 94-AR-0194 or 98-AR-0150. Joint MRI: Patient must have at least one clinically active arthritic joint that is under consideration for percutaneous needle synovial biopsy. Joint MRI: Patients must not have the following: cardiac pacemakers, auto defibrillators, neural stimulators, aneurysm clips, metallic prostheses, cochlear (ear) implants, any implanted devices (pumps, infusion devices, etc.), metal fragments in the eye, or shrapnel injuries. Joint MRI: Patients must not exceed the size limitations of the MRI scanner. Joint MRI: Must not suffer from claustrophobia. Joint MRI: Must not have had a previous anaphylactoid reaction to gadolinium-based contrast material. Joint MRI: Must not be pregnant.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

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

Bethesda, United StatesOpen National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) in Google Maps
CompletedOne Study Center