Brigham and Women's Rheumatoid Arthritis Sequential Study (BRASS)
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|ClinicalTrials.gov Identifier: NCT01793103|
Recruitment Status : Active, not recruiting
First Posted : February 15, 2013
Last Update Posted : March 15, 2021
The goal of the present study is to establish a prospective observational cohort of Rheumatoid Arthritis patients in order to
- Determine and validate biomarkers that predict drug response and toxicity in RA.
- Determine and validate biomarkers that predict disease activity and prognosis in RA.
- Evaluate the natural history of treated RA in terms of its clinical, functional and economic outcomes.
|Condition or disease|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1600 participants|
|Target Follow-Up Duration:||20 Years|
|Official Title:||Brigham and Women's Rheumatoid Arthritis Sequential Study|
|Study Start Date :||March 2003|
|Estimated Primary Completion Date :||March 2028|
|Estimated Study Completion Date :||March 2028|
- Determine and validate biomarkers that predict drug response and toxicity in RA. [ Time Frame: 15 years ]Determine and validate biomarkers that predict drug response and toxicity in RA.
- Determine and validate biomarkers that predict disease activity and prognosis in RA. [ Time Frame: 15 years ]Determine and validate biomarkers that predict disease activity and prognosis in RA.
- Evaluate the natural history of treated RA in terms of its clinical, functional and economic outcomes. [ Time Frame: 15 years ]Evaluate the natural history of treated RA in terms of its clinical, functional and economic outcomes.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793103
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Nancy A Shadick, MD, MPH||Brigham and Women's Hospital|