The Registry will be a prospective observational study totaling 1600 patients diagnosed
with RA. Patients who are 18 years of age or greater, are a patient at the R.B. Brigham
Arthritis Center and have been diagnosed with RA meet entry criteria.
Once patients have agreed to participate and sign an informed consent form, they will
undergo a detailed baseline examination to include demographic and clinical information,
functional status, disease activity, comorbidity, laboratory testing and hand
radiographs. RA criteria will be determined by the rheumatologist documenting ACR
criteria and a medical record review. The primary outcomes of interest will be the
presence of erosive and extra-articular disease, decline in functional status and
significant drug toxicity. A sample of blood and urine will be stored for DNA/RNA
testing. During this time either through interview or self-administered questionnaires,
they will be asked information about their disease severity, functional status, resource
utilization, level of fatigue, employment status, medications and adverse events.
Information will be obtained at the time of enrollment in the Registry, during annual
examinations, from semi-annual questionnaires and annual follow-up visits, as well as
from medical records. Subjects will be followed for 5 years at which time they will be
asked if they would like to consent to an additional 5 years. At the 10 year visit,
subjects still enrolled will be given the option to consent for an additional 5 years.
Subjects will be given the option within the consent forms to agree or not to the
collection of their discarded specimens to analyze cells and soluble factors such as
proteins in the blood to determine how they can affect the course of rheumatoid arthritis
and how it develops in different individuals.
Patients with a billing diagnosis of RA (714.0) or seronegative inflammatory arthritis
(714.9) over the age of 18 years old who are enrolled in the Robert Breck Brigham
Arthritis Center will be eligible for recruitment. Rheumatologists within the Division of
Rheumatology, Immunology and Allergy who evaluate patients in the R.B. Brigham Arthritis
Center will be asked for permission to contact patients with a tentative diagnosis of RA
based upon ICD billing code. A letter describing the study, Dr. Nancy Shadick, and the
primary rheumatologist will be sent to the subject 7-10 days prior to their next
scheduled visit. The consent form will be included with the letter so they will have time
to discuss it with family and others. In the case of non-English speaking patients, the
short form consent form will be presented and an interpreter will be supplied.
A letter describing the study, signed by Dr. Shadick, the PI, and the patient's primary
rheumatologist will be sent to the patient 7-10 days prior to their next scheduled visit.
An informed consent document will be sent at that time for the patient to read over and
to discuss with family and others. If they are interested in participating in the study,
the subject will be asked to bring the informed consent document to the appointment with
their rheumatologist. Either the participating rheumatologist or research coordinator
trained in explaining the protocol in detail will obtain the consent. Each research
coordinator that will be involved in obtaining consents will undergo a 1 hour training
session with the principal investigator, Nancy A. Shadick, MD. The investigator will
review the general principles, benefits and risks of genetic analysis as well as details
of the study. All subjects must be able to give consent for the study themselves.
