Clinical trial NCT00006333: Study of Arthritis and Related Conditions
Official title: Studies of the Pathogenesis and Natural History of Arthritis and Related Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Pathogenesis
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2000-10-05
Enrollment: 697
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with known or suspected arthritis

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.

Eligibility 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.

Primary outcomes:
measure: Determine patterns of arthritis
timeFrame: End of the study
Secondary outcomes:
measure: Confirmatory Studies In RA and related diseases
timeFrame: End of the study
measure: Co-culture experiments using synovial tissue and surgical cartilage specimens
timeFrame: End of the study
measure: MRI Imaging in RA and related diseases
timeFrame: End of the study
measure: Collection of DNA in RA and related diseases
timeFrame: End of the study
measure: Evaluation of early disability in RA and related diseases
timeFrame: End of the study
measure: Assess cytokine profiles
timeFrame: End of the study
measure: Correlate the cartilage and bone markers of tissue destruction and repair with MRI images
timeFrame: End of the study
measure: Determine the degree of early disability
timeFrame: End of the study
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: James D Katz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: