Have you or your loved ones been diagnosed with rheumatoid arthritis?

You may be eligible to participate in a rheumatoid arthritis clinical trial.

Have you or your loved ones been diagnosed with rheumatoid arthritis? You may be eligible to participate in a rheumatoid arthritis clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Rheumatoid Arthritis Clinical Trial in Bethesda MD

NCT00006333 | Observational

Have you or your loved ones been diagnosed with rheumatoid arthritis?

You may be eligible to participate in a rheumatoid arthritis clinical trial.

Have you or your loved ones been diagnosed with rheumatoid arthritis? You may be eligible to participate in a rheumatoid arthritis clinical trial.

Active not recruiting

Male & Female

All ages

This study has recruited 697 Participants

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.

Show me more details

Details for the study

Population

Subjects with known or suspected arthritis

Brief Title

Study of Arthritis and Related Conditions

Official Title

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

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

Determine patterns of arthritis

Evaluate natural history and disease trajectories in rheumatoid arthritis

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

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

Study 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.