Study of Arthritis and Related Conditions

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006333
• Other study ID #: 000222
• Secondary ID: 00-AR-0222
• Status: Completed
• Start date: October 3, 2000
• Est. completion date: March 10, 2021

Study information

• Verified date: March 2021
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 697
• Est. completion date: March 10, 2021
• Est. primary completion date: March 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Arthritis
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine patterns of arthritis	Evaluate natural history and disease trajectories in rheumatoid arthritis	End of the study
Secondary	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.	End of the study
Secondary	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	End of the study
Secondary	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.	End of the study
Secondary	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.	End of the study
Secondary	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.	End of the study
Secondary	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.	End of the study
Secondary	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.	End of the study
Secondary	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.	End of the study

External Links

•   NIH Clinical Center Detailed Web Page