Brigham and Women's Rheumatoid Arthritis Sequential Study

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.

Inclusion Criteria:

1. Are 18 years of age or older;

2. Are a patient registered at the R.B.Brigham Arthritis Center.

3. Have, at the time of enrollment a diagnosis of RA made by a board certified
rheumatologist.

4. Are able and willing to provide informed consent.

Exclusion Criteria:

- less than 18 years of age

- do not have a diagnosis of RA

- have a history of SLE or Psoriasis