Brigham and Women's Rheumatoid Arthritis Sequential Study

Rheumatoid Arthritis Clinical Trial

— BRASS  

Official title:

Brigham and Women's Rheumatoid Arthritis Sequential Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01793103
• Other study ID #: 2002P0001762
• Status: Active, not recruiting
• Start date: March 2003
• Est. completion date: March 2028

Study information

• Verified date: March 2021
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The goal of the present study is to establish a prospective observational cohort of Rheumatoid Arthritis patients in order to

1. Determine and validate biomarkers that predict drug response and toxicity in RA.

2. Determine and validate biomarkers that predict disease activity and prognosis in RA.

3. Evaluate the natural history of treated RA in terms of its clinical, functional and economic outcomes.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1600
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Bristol-Myers Squibb, Crescendo Bioscience, UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine and validate biomarkers that predict drug response and toxicity in RA.	Determine and validate biomarkers that predict drug response and toxicity in RA.	15 years
Secondary	Determine and validate biomarkers that predict disease activity and prognosis in RA.	Determine and validate biomarkers that predict disease activity and prognosis in RA.	15 years
Secondary	Evaluate the natural history of treated RA in terms of its clinical, functional and economic outcomes.	Evaluate the natural history of treated RA in terms of its clinical, functional and economic outcomes.	15 years