Arthritis, PsoriaticNCT00001291
Genetic and Immune Studies of Rheumatoid Arthritis and Related Conditions
An observational study of Arthritis, Psoriatic and Autoimmune Diseases, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial summary
This protocol will examine blood, synovial fluid and synovial tissue from patients with rheumatoid arthritis and other chronic inflammatory joint diseases to study genetic and immunologic factors involved in the cause, development and progression of these conditions. Synovial fluid is the lubricating fluid in joints. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthritis, Psoriatic, Autoimmune Diseases, Joint Diseases
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Dec 1991to Jan 2001
- 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
- No healthy volunteers
- Child, Adult, Older adult
Patients with rheumatoid arthritis, particularly new onset disease, but certain patients with other forms of arthritis will also be included.
Significantly swollen or tender knee or significantly swollen shoulders, elbows, wrists, ankles, olecranon bursa or even smaller joints.
Synovial tissue specimens will not be obtained from patients when any of the following conditions are present: abnormal bleeding or clotting tests, platelet count less than 100,000, or sepsis.
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
Official title: Investigations of Blood, Synovial Tissue and Synovial Fluids From Patients With Rheumatoid Arthritis and Related Conditions
This protocol will examine blood, synovial fluid and synovial tissue from patients with rheumatoid arthritis and other chronic inflammatory joint diseases to study genetic and immunologic factors involved in the cause, development and progression of these conditions. Synovial fluid is the lubricating fluid in joints. The synovial membrane is a delicate tissue lining the inner surface of joints, which, in arthritic conditions, thickens and becomes infiltrated with various types of cells.
Patients with rheumatoid arthritis and certain patients with other forms of arthritis may be eligible for this study. Those enrolled will be followed periodically for follow-up and disease evaluation. They may undergo the following procedures:
Read more
- Synovial fluid aspiration, when medically indicated (for example, for joint swelling and inflammation). For this procedure, an area of skin around the joint is numbed with an anesthetic, and a needle is inserted into the joint to withdraw a small fluid sample.
- Periodic blood sampling, not to exceed 450 milliliters (15 ounces) during any 6-week period, for genetic studies of rheumatoid arthritis. The samples are usually taken at the same times that synovial fluid is withdrawn.
- Synovial tissues, collected by needle biopsy or during surgical procedures for arthroscopy (examination of the interior of the joint and repair of the joint) or total joint replacement. For the needle biopsy, the skin over the biopsy site is washed and anesthetized. A needle is inserted and fluid is aspirated. The biopsy needle is then inserted through the outer needle and a tissue sample is suctioned.
Patients who qualify for other research studies may be invited to participate.
Read the detailed description
Blood, synovial fluids and/or synovial tissues will be obtained from patients with rheumatoid arthritis and related chronic inflammatory arthritides. The synovial tissues will be obtained by one of the following methods: a) needle biopsy, or b) at the time of a total joint replacement or a therapeutic arthroscopic procedure. These materials will be utilized for laboratory studies of etiopathogenetic mechanisms of rheumatoid arthritis and related autoimmune joint diseases.
- Conditions
- Arthritis, Psoriatic, Autoimmune Diseases, Joint Diseases, Osteoarthritis, Rheumatoid Arthritis
- Keywords
- Osteoarthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Synovial Biopsy, Synovitis, Synovium
- Medical subject headings
- Arthritis, Psoriatic, Autoimmune Diseases, Joint Diseases, Osteoarthritis, Arthritis, Rheumatoid, Synovitis
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 startDec 1991
- Study completionJan 2001
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 Arthritis, PsoriaticStudies 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
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
- NCT00001291
- Sponsor's protocol ID
- 920065
- Other IDs
- 92-AR-0065
- Status last verified
- Dec 1999
- First submitted
- 3 Nov 1999
- Last updated
- 5 Mar 2008
- Results posted
- No
Publications
Lafyatis R, Remmers EF, Roberts AB, Yocum DE, Sporn MB, Wilder RL. Anchorage-independent growth of synoviocytes from arthritic and normal joints. Stimulation by exogenous platelet-derived growth factor and inhibition by transforming growth factor-beta and retinoids. J Clin Invest. 1989 Apr;83(4):1267-76. doi: 10.1172/JCI114011.
PubMed 2784799Kumkumian GK, Lafyatis R, Remmers EF, Case JP, Kim SJ, Wilder RL. Platelet-derived growth factor and IL-1 interactions in rheumatoid arthritis. Regulation of synoviocyte proliferation, prostaglandin production, and collagenase transcription. J Immunol. 1989 Aug 1;143(3):833-7.
PubMed 2545778Lafyatis R, Thompson NL, Remmers EF, Flanders KC, Roche NS, Kim SJ, Case JP, Sporn MB, Roberts AB, Wilder RL. Transforming growth factor-beta production by synovial tissues from rheumatoid patients and streptococcal cell wall arthritic rats. Studies on secretion by synovial fibroblast-like cells and immunohistologic localization. J Immunol. 1989 Aug 15;143(4):1142-8.
PubMed 2663990
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigations of Blood, Synovial Tissue and Synovial Fluids From Patients With Rheumatoid Arthritis and Related Conditions
- ClinicalTrials.gov ID
- NCT00001291
- Acronym / sponsor ID
- 920065
- Conditions
- Arthritis, Psoriatic, Autoimmune Diseases, Joint Diseases, Osteoarthritis, Rheumatoid Arthritis
- Keywords
- Osteoarthritis, Psoriatic Arthritis, Rheumatoid Arthritis, Synovial Biopsy, Synovitis, Synovium
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- Dec 1991
- Study completion
- Jan 2001
- 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 protocol will examine blood, synovial fluid and synovial tissue from patients with rheumatoid arthritis and other chronic inflammatory joint diseases to study genetic and immunologic factors involved in the cause, development and progression of these conditions. Synovial fluid is the lubricating fluid in joints. The synovial membrane is a delicate tissue lining the inner surface of joints, which, in arthritic conditions, thickens and becomes infiltrated with various types of cells.
Patients with rheumatoid arthritis and certain patients with other forms of arthritis may be eligible for this study. Those enrolled will be followed periodically for follow-up and disease evaluation. They may undergo the following procedures:
- Synovial fluid aspiration, when medically indicated (for example, for joint swelling and inflammation). For this procedure, an area of skin around the joint is numbed with an anesthetic, and a needle is inserted into the joint to withdraw a small fluid sample.
- Periodic blood sampling, not to exceed 450 milliliters (15 ounces) during any 6-week period, for genetic studies of rheumatoid arthritis. The samples are usually taken at the same times that synovial fluid is withdrawn.
- Synovial tissues, collected by needle biopsy or during surgical procedures for arthroscopy (examination of the interior of the joint and repair of the joint) or total joint replacement. For the needle biopsy, the skin over the biopsy site is washed and anesthetized. A needle is inserted and fluid is aspirated. The biopsy needle is then inserted through the outer needle and a tissue sample is suctioned.
Patients who qualify for other research studies may be invited to participate.
Detailed description
Blood, synovial fluids and/or synovial tissues will be obtained from patients with rheumatoid arthritis and related chronic inflammatory arthritides. The synovial tissues will be obtained by one of the following methods: a) needle biopsy, or b) at the time of a total joint replacement or a therapeutic arthroscopic procedure. These materials will be utilized for laboratory studies of etiopathogenetic mechanisms of rheumatoid arthritis and related autoimmune joint diseases.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not 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 5 Mar 2008.
- Background: PubMed 2784799Lafyatis R, Remmers EF, Roberts AB, Yocum DE, Sporn MB, Wilder RL. Anchorage-independent growth of synoviocytes from arthritic and normal joints. Stimulation by exogenous platelet-derived growth factor and inhibition by transforming growth factor-beta and retinoids. J Clin Invest. 1989 Apr;83(4):1267-76. doi: 10.1172/JCI114011.
- Background: PubMed 2545778Kumkumian GK, Lafyatis R, Remmers EF, Case JP, Kim SJ, Wilder RL. Platelet-derived growth factor and IL-1 interactions in rheumatoid arthritis. Regulation of synoviocyte proliferation, prostaglandin production, and collagenase transcription. J Immunol. 1989 Aug 1;143(3):833-7.
- Background: PubMed 2663990Lafyatis R, Thompson NL, Remmers EF, Flanders KC, Roche NS, Kim SJ, Case JP, Sporn MB, Roberts AB, Wilder RL. Transforming growth factor-beta production by synovial tissues from rheumatoid patients and streptococcal cell wall arthritic rats. Studies on secretion by synovial fibroblast-like cells and immunohistologic localization. J Immunol. 1989 Aug 15;143(4):1142-8.
Related trials for Arthritis, Psoriatic
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingPhase 4
Impact of Glucagon-like Peptide-1 (GLP-1) Analogs on Disease Outcomes in Psoriatic Arthritis: A Pragmatic Randomized Controlled Trial
Psoriatic Arthritis (PsA)
Active, not recruitingPhase 3
Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
Psoriatic Arthritis
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, Psoriatic and Autoimmune Diseases, 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 5 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 NCT00001291, 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 5 Mar 2008.