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Study of Arthritis and Related Conditions

Studies of the Pathogenesis and Natural History of Arthritis and Related Conditions

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00006333
Enrollment
697
Registered
2000-10-05
Start date
2000-10-03
Completion date
2021-03-10
Last updated
2021-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Pathogenesis

Brief 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. 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.

Interventions

None listed

Sponsors

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

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* INCLUSION CRITERIA: 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.

Exclusion criteria

None if patients fulfill inclusion criteria.

Design outcomes

Primary

MeasureTime frameDescription
Determine patterns of arthritisEnd of the studyEvaluate natural history and disease trajectories in rheumatoid arthritis

Secondary

MeasureTime frameDescription
Co-culture experiments using synovial tissue and surgical cartilage specimensEnd of the studyThe 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
MRI Imaging in RA and related diseasesEnd of the studyWe 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.
Collection of DNA in RA and related diseasesEnd of the studyGenetic 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.
Confirmatory Studies In RA and related diseasesEnd of the studyWe 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.
Assess cytokine profilesEnd of the studyWe 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.
Correlate the cartilage and bone markers of tissue destruction and repair with MRI imagesEnd of the studyWe 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.
Determine the degree of early disabilityEnd of the studyVery 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.
Evaluation of early disability in RA and related diseasesEnd of the studyAnalysis 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026