Rheumatoid ArthritisNCT00006333
Study of Arthritis and Related Conditions
An observational study of Rheumatoid Arthritis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial summary
This research protocol will recruit patients with arthritis and related conditions for the purpose of screening patients for treatment protocols, and evaluating the natural history of arthritis and related conditions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 697 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2000to 10 Mar 2021
- 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
Study population: Subjects with known or suspected arthritis
Who may be able to join
- No age limits.
- History of inflammatory synovitis of at least one or more swollen joints.
- Patient's ability and willingness to give informed consent or in the pediatric patients, the parent's willingness to give informed consent and the patient's willingness to assent to the protocol whenever possible.
Who cannot join
- None if patients fulfill inclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Studies of the Pathogenesis and Natural History of Arthritis and Related Conditions
This research protocol will recruit patients with arthritis and related conditions for the purpose of screening patients for treatment protocols, and evaluating the natural history of arthritis and related conditions. Patients will be evaluated clinically, radiographically and serologically, and standardized data will be uniformly collected on all patients. Additional imaging using sensitive MRI methods will be obtained in some patients. The collected blood and tissue will be utilized for laboratory studies to continue research on the pathogenic mechanisms of rheumatoid arthritis and related autoimmune joint diseases. Data from the history and physical examination as well as several disability questionnaires in the adult and pediatric population will be used to phenotypically characterize these patients and assess outcome and functional status. Any medical care recommended or provided to the patients will be consistent with routine standards of practice and provided in consultation with the patient's referring physician.
Read the detailed description
This research protocol will recruit patients with arthritis and related conditions for the purpose of screening patients for treatment protocols, and evaluating the natural history of arthritis and related conditions. Patients will be evaluated clinically, radiographically and serologically, and standardized data will be uniformly collected on all patients. Additional imaging using sensitive MRI methods will be obtained in some patients. The collected blood and tissue will be utilized for laboratory studies to continue research on the pathogenic mechanisms of rheumatoid arthritis and related autoimmune joint diseases. Data from the history and physical examination as well as several disability questionnaires in the adult and pediatric population will be used to phenotypically characterize these patients and assess outcome and functional status. Any medical care recommended or provided to the patients will be consistent with routine standards of practice and provided in consultation with the patient's referring physician.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Pathogenesis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with known or suspected arthritis | Subjects with known or suspected arthritis will be evaluated longitudinally |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine patterns of arthritis
Evaluate natural history and disease trajectories in rheumatoid arthritis
Measured: End of the study
Secondary outcomes (8)
Confirmatory Studies In RA and related diseases
We would like to continue confirmatory studies and test whether serologic disease markers identified early in the course of the disease are indeed markers of disease severity in patients with more established forms of the disease.
Measured: End of the study
Co-culture experiments using synovial tissue and surgical cartilage specimens
The erosive potential of some but not all forms of arthritis is still poorly understood. We propose to resume co-culture experiments using synovial tissue and surgical cartilage specimens to develop a tissue model of bone erosions using the bioreactor
Measured: End of the study
MRI Imaging in RA and related diseases
We would like to use patients from this cohort to develop the analysis of MRI images, including three dimensionally reconstructed images, and test their use in the evaluation of joint damage and impact on early diagnosis and therapeutic decisions.
Measured: End of the study
Collection of DNA in RA and related diseases
Genetic associations need to be tested in large populations of patients with heterogenous diseases. We would like to continue the collection of DNA in a cohort of clinically well-characterized patients to allow for genetic analysis once a critical body of patients has been collected.
Measured: End of the study
Evaluation of early disability in RA and related diseases
Analysis of the degree of early disability resulting from inflammatory arthritis in the early synovitis cohort patients is currently ongoing. We intend to continue work with the rehabilitation department on the analysis of the extent of disability related to the inflammatory conditions and associated factors in the adult and pediatric population.
Measured: End of the study
Assess cytokine profiles
We would like to comprehensively assess cytokine profiles in the serum of patients with pauciarticular, poly-articular and systemic onset JRA and the influence of response to treatment on cytokine changes.
Measured: End of the study
Correlate the cartilage and bone markers of tissue destruction and repair with MRI images
We would further like to correlate the cartilage and bone markers of tissue destruction and repair with the amount of damage seen on MRI in the different patient disease subsets.
Measured: End of the study
Determine the degree of early disability
Very subtle degrees of early disability have been seen in patients with relatively short disease duration. We would like to determine the degree of early disability in JRA patients and correlate measures of disability with the number, joint location and degree of joint damage on MRI.
Measured: End of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2000 (estimated)
- Study start3 Oct 2000
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 697 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- James D Katz, M.D., Principal investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006333
- Sponsor's protocol ID
- 000222
- Other IDs
- 00-AR-0222
- Status last verified
- Mar 2021
- First submitted
- 4 Oct 2000
- Last updated
- 12 Mar 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of the Pathogenesis and Natural History of Arthritis and Related Conditions
- ClinicalTrials.gov ID
- NCT00006333
- Acronym / sponsor ID
- 000222
- Conditions
- Rheumatoid Arthritis
- Keywords
- Pathogenesis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 697 participants (actual)
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- 3 Oct 2000 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 5 Oct 2000 (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 research protocol will recruit patients with arthritis and related conditions for the purpose of screening patients for treatment protocols, and evaluating the natural history of arthritis and related conditions. Patients will be evaluated clinically, radiographically and serologically, and standardized data will be uniformly collected on all patients. Additional imaging using sensitive MRI methods will be obtained in some patients. The collected blood and tissue will be utilized for laboratory studies to continue research on the pathogenic mechanisms of rheumatoid arthritis and related autoimmune joint diseases. Data from the history and physical examination as well as several disability questionnaires in the adult and pediatric population will be used to phenotypically characterize these patients and assess outcome and functional status. Any medical care recommended or provided to the patients will be consistent with routine standards of practice and provided in consultation with the patient's referring physician.
Detailed description
This research protocol will recruit patients with arthritis and related conditions for the purpose of screening patients for treatment protocols, and evaluating the natural history of arthritis and related conditions. Patients will be evaluated clinically, radiographically and serologically, and standardized data will be uniformly collected on all patients. Additional imaging using sensitive MRI methods will be obtained in some patients. The collected blood and tissue will be utilized for laboratory studies to continue research on the pathogenic mechanisms of rheumatoid arthritis and related autoimmune joint diseases. Data from the history and physical examination as well as several disability questionnaires in the adult and pediatric population will be used to phenotypically characterize these patients and assess outcome and functional status. Any medical care recommended or provided to the patients will be consistent with routine standards of practice and provided in consultation with the patient's referring physician.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with known or suspected arthritis | – | –Subjects with known or suspected arthritis will be evaluated longitudinally |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with known or suspected arthritis
Key inclusion criteria (3 listed)
- No age limits.
- History of inflammatory synovitis of at least one or more swollen joints.
- Patient's ability and willingness to give informed consent or in the pediatric patients, the parent's willingness to give informed consent and the patient's willingness to assent to the protocol whenever possible.
Key exclusion criteria (1 listed)
- None if patients fulfill inclusion criteria.
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
Determine patterns of arthritis
Time frame: End of the study
Evaluate natural history and disease trajectories in rheumatoid arthritis
8 secondary outcomes
Confirmatory Studies In RA and related diseases
Time frame: End of the study
Co-culture experiments using synovial tissue and surgical cartilage specimens
Time frame: End of the study
MRI Imaging in RA and related diseases
Time frame: End of the study
Collection of DNA in RA and related diseases
Time frame: End of the study
Evaluation of early disability in RA and related diseases
Time frame: End of the study
Assess cytokine profiles
Time frame: End of the study
Correlate the cartilage and bone markers of tissue destruction and repair with MRI images
Time frame: End of the study
Determine the degree of early disability
Time frame: End of the study
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 12 Mar 2021.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
James D Katz, M.D. principal investigator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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 Rheumatoid Arthritis, 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.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2021. 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.
What does the primary outcome measure?
Determine patterns of arthritis (time frame: End of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2021; AzTrials last refreshed its copy on 7 Nov 2026.