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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Brigham and Women's Hospital
Sponsor:
Collaborators:
Crescendo Bioscience
Bristol-Myers Squibb
UCB, Inc.
Information provided by (Responsible Party):
Nancy Shadick, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01793103
First received: February 14, 2013
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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.

Condition
Rheumatoid Arthritis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Years
Official Title: Brigham and Women's Rheumatoid Arthritis Sequential Study

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Determine and validate biomarkers that predict drug response and toxicity in RA. [ Time Frame: 15 years ] [ Designated as safety issue: No ]
    Determine and validate biomarkers that predict drug response and toxicity in RA.


Secondary Outcome Measures:
  • Determine and validate biomarkers that predict disease activity and prognosis in RA. [ Time Frame: 15 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Evaluate the natural history of treated RA in terms of its clinical, functional and economic outcomes.


Biospecimen Retention:   Samples With DNA

whole blood, serum, DNA


Estimated Enrollment: 1600
Study Start Date: March 2003
Estimated Study Completion Date: March 2028
Estimated Primary Completion Date: March 2028 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adults 18 years or older with Rheumatoid Arthritis

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793103

Contacts
Contact: Christine K Iannaccone, MPH 617-732-5083 ciannaccone@partners.org
Contact: Michelle L Frits 617-732-5149 mfrits@partners.org

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Christine K Iannaccone, MPH    617-732-5083    ciannaccone@partners.org   
Contact: Michelle L Frits    617-732-5149    mfrits@partners.org   
Principal Investigator: Nancy A Shadick, MPH         
Sponsors and Collaborators
Brigham and Women's Hospital
Crescendo Bioscience
Bristol-Myers Squibb
UCB, Inc.
Investigators
Principal Investigator: Nancy A Shadick, MD, MPH Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Nancy Shadick, Assistant Professor, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01793103     History of Changes
Other Study ID Numbers: 2002P0001762
Study First Received: February 14, 2013
Last Updated: January 9, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 18, 2014