ArthritisNCT00001375
The Pathogenesis of Inflammatory Synovitis: A Study of Early Arthritis
An observational study of Arthritis and Arthritis, Reactive, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Arthritis, Arthritis, Reactive, Arthritis, Rheumatoid
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1994to Jun 2000
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Bethesda, Maryland, 20892
About this study
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.
Read the detailed description
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.
- Keywords
- Infection, Reactive Arthritis, Rheumatoid Arthritis, Synovial Biopsy, Synovial Fluid, Synovitis
- Medical subject headings
- Arthritis, Arthritis, Reactive, Arthritis, Rheumatoid, Synovitis, Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startAug 1994
- Study completionJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001375
- Sponsor's protocol ID
- 940194
- Other IDs
- 94-AR-0194
- Status last verified
- Aug 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Kotake S, Schumacher HR Jr, Yarboro CH, Arayssi TK, Pando JA, Kanik KS, Gourley MF, Klippel JH, Wilder RL. In vivo gene expression of type 1 and type 2 cytokines in synovial tissues from patients in early stages of rheumatoid, reactive, and undifferentiated arthritis. Proc Assoc Am Physicians. 1997 May;109(3):286-301.
PubMed 9154645Kanik KS, Hagiwara E, Yarboro CH, Schumacher HR, Wilder RL, Klinman DM. Distinct patterns of cytokine secretion characterize new onset synovitis versus chronic rheumatoid arthritis. J Rheumatol. 1998 Jan;25(1):16-22.
PubMed 9458197Schumacher HR, Kitridou RC. Synovitis of recent onset. A clinicopathologic study during the first month of disease. Arthritis Rheum. 1972 Sep-Oct;15(5):465-85. doi: 10.1002/art.1780150502. No abstract available.
PubMed 4117789
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pathogenesis of Inflammatory Synovitis: A Study of Early Arthritis
- ClinicalTrials.gov ID
- NCT00001375
- Acronym / sponsor ID
- 940194
- Keywords
- Infection, Reactive Arthritis, Rheumatoid Arthritis, Synovial Biopsy, Synovial Fluid, Synovitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- Aug 1994
- Study completion
- Jun 2000
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 9154645Kotake S, Schumacher HR Jr, Yarboro CH, Arayssi TK, Pando JA, Kanik KS, Gourley MF, Klippel JH, Wilder RL. In vivo gene expression of type 1 and type 2 cytokines in synovial tissues from patients in early stages of rheumatoid, reactive, and undifferentiated arthritis. Proc Assoc Am Physicians. 1997 May;109(3):286-301.
- Background: PubMed 9458197Kanik KS, Hagiwara E, Yarboro CH, Schumacher HR, Wilder RL, Klinman DM. Distinct patterns of cytokine secretion characterize new onset synovitis versus chronic rheumatoid arthritis. J Rheumatol. 1998 Jan;25(1):16-22.
- Background: PubMed 4117789Schumacher HR, Kitridou RC. Synovitis of recent onset. A clinicopathologic study during the first month of disease. Arthritis Rheum. 1972 Sep-Oct;15(5):465-85. doi: 10.1002/art.1780150502. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis and Arthritis, Reactive, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001375, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.