Brigham and Women's Rheumatoid Arthritis Sequential Study (BRASS)

September 23, 2025 updated by: Nancy Shadick, Brigham and Women's Hospital

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.

Study Overview

Status

Active, not recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

1598

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults 18 years or older with Rheumatoid Arthritis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
15 years
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.
15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Bristol-Myers Squibb
Sanofi
UCB Pharma
Janssen, LP
Crescendo Bioscience
Aqtual, Inc.

Investigators

  • Principal Investigator: Nancy A Shadick, MD, MPH, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

February 14, 2013

First Submitted That Met QC Criteria

February 14, 2013

First Posted (Estimated)

February 15, 2013

Study Record Updates

Last Update Posted (Estimated)

September 26, 2025

Last Update Submitted That Met QC Criteria

September 23, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2002P0001762

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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