Rheumatoid ArthritisBRASSNCT01793103
Brigham and Women's Rheumatoid Arthritis Sequential Study
An observational study of Rheumatoid Arthritis, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 1,598 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Mar 2028
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults 18 years or older with Rheumatoid Arthritis
Who may be able to join
- Are 18 years of age or older;
- Are a patient registered at the R.B.Brigham Arthritis Center.
- Have, at the time of enrollment a diagnosis of RA made by a board certified rheumatologist.
- Are able and willing to provide informed consent.
Who cannot join
- less than 18 years of age
- do not have a diagnosis of RA
- have a history of SLE or Psoriasis
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine and validate biomarkers that predict drug response and toxicity in RA.
Determine and validate biomarkers that predict drug response and toxicity in RA.
Measured: 15 years
Secondary outcomes (2)
Determine and validate biomarkers that predict disease activity and prognosis in RA.
Determine and validate biomarkers that predict disease activity and prognosis in RA.
Measured: 15 years
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.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startMar 2003
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,598 participants (actual)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Crescendo Bioscience, Bristol-Myers Squibb, UCB Pharma, Sanofi, Janssen, LP, Aqtual, Inc.
- Responsible party
- Principal investigator, Nancy Shadick, Brigham and Women's Hospital
- Investigators
- Nancy A Shadick, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793103
- Sponsor's protocol ID
- 2002P0001762
- Acronym
- BRASS
- Status last verified
- Sep 2025
- First submitted
- 14 Feb 2013
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Shadick N, Hagino O, Praestgaard A, Fiore S, Weinblatt M, Burmester G. Association of hemoglobin levels with radiographic progression in patients with rheumatoid arthritis: an analysis from the BRASS registry. Arthritis Res Ther. 2023 May 27;25(1):88. doi: 10.1186/s13075-023-03068-w.
PubMed 37237405Zhuo J, Xia Q, Sharma N, Gao S, Lama S, Cui J, Feathers V, Shadick N, Weinblatt ME. The Role of Shared Epitope in Rheumatoid Arthritis Prognosis in Relation to Anti-Citrullinated Protein Antibody Positivity. Rheumatol Ther. 2022 Apr;9(2):637-647. doi: 10.1007/s40744-022-00427-y. Epub 2022 Feb 16.
PubMed 35174462Shadick NA, Gerlanc NM, Frits ML, Stolshek BS, Brady BL, Iannaccone C, Collier D, Cui J, Mutebi A, Weinblatt ME. The longitudinal effect of biologic use on patient outcomes (disease activity, function, and disease severity) within a rheumatoid arthritis registry. Clin Rheumatol. 2019 Nov;38(11):3081-3092. doi: 10.1007/s10067-019-04649-4. Epub 2019 Jul 29.
PubMed 31353421Alemao E, Iannaccone CK, Weinblatt ME, Shadick NA. Association of Changes in Anticitrullinated Protein Antibody Levels With Resource Use and Disease Activity Measures in Rheumatoid Arthritis Patients a US Observational Cohort. Clin Ther. 2019 Jun;41(6):1057-1065.e3. doi: 10.1016/j.clinthera.2019.04.029. Epub 2019 May 23.
PubMed 31130229Ahmad HA, Alemao E, Guo Z, Iannaccone CK, Frits ML, Weinblatt M, Shadick NA. Association of Low Bone Mineral Density with Anti-Citrullinated Protein Antibody Positivity and Disease Activity in Established Rheumatoid Arthritis: Findings from a US Observational Cohort. Adv Ther. 2018 Feb;35(2):232-242. doi: 10.1007/s12325-017-0657-x. Epub 2018 Jan 25.
PubMed 29368271Alemao E, Guo Z, Frits ML, Iannaccone CK, Shadick NA, Weinblatt ME. Association of anti-cyclic citrullinated protein antibodies, erosions, and rheumatoid factor with disease activity and work productivity: A patient registry study. Semin Arthritis Rheum. 2018 Apr;47(5):630-638. doi: 10.1016/j.semarthrit.2017.10.009. Epub 2017 Oct 13.
PubMed 29241640Alemao E, Joo S, Kawabata H, Al MJ, Allison PD, Rutten-van Molken MP, Frits ML, Iannaccone CK, Shadick NA, Weinblatt ME. Effects of Achieving Target Measures in Rheumatoid Arthritis on Functional Status, Quality of Life, and Resource Utilization: Analysis of Clinical Practice Data. Arthritis Care Res (Hoboken). 2016 Mar;68(3):308-17. doi: 10.1002/acr.22678.
PubMed 26238974
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brigham and Women's Rheumatoid Arthritis Sequential Study
- ClinicalTrials.gov ID
- NCT01793103
- Acronym / sponsor ID
- BRASS / 2002P0001762
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,598 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Crescendo Bioscience, Bristol-Myers Squibb, UCB Pharma, Sanofi, Janssen, LP, Aqtual, Inc.
- Study start
- Mar 2003
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 15 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 18 years or older with Rheumatoid Arthritis
Key inclusion criteria (4 listed)
- Are 18 years of age or older;
- Are a patient registered at the R.B.Brigham Arthritis Center.
- Have, at the time of enrollment a diagnosis of RA made by a board certified rheumatologist.
- Are able and willing to provide informed consent.
Key exclusion criteria (3 listed)
- less than 18 years of age
- do not have a diagnosis of RA
- have a history of SLE or Psoriasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Determine and validate biomarkers that predict disease activity and prognosis in RA.
Time frame: 15 years
Evaluate the natural history of treated RA in terms of its clinical, functional and economic outcomes.
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Derived from this study: PubMed 37237405Shadick N, Hagino O, Praestgaard A, Fiore S, Weinblatt M, Burmester G. Association of hemoglobin levels with radiographic progression in patients with rheumatoid arthritis: an analysis from the BRASS registry. Arthritis Res Ther. 2023 May 27;25(1):88. doi: 10.1186/s13075-023-03068-w.
- Derived from this study: PubMed 35174462Zhuo J, Xia Q, Sharma N, Gao S, Lama S, Cui J, Feathers V, Shadick N, Weinblatt ME. The Role of Shared Epitope in Rheumatoid Arthritis Prognosis in Relation to Anti-Citrullinated Protein Antibody Positivity. Rheumatol Ther. 2022 Apr;9(2):637-647. doi: 10.1007/s40744-022-00427-y. Epub 2022 Feb 16.
- Derived from this study: PubMed 31353421Shadick NA, Gerlanc NM, Frits ML, Stolshek BS, Brady BL, Iannaccone C, Collier D, Cui J, Mutebi A, Weinblatt ME. The longitudinal effect of biologic use on patient outcomes (disease activity, function, and disease severity) within a rheumatoid arthritis registry. Clin Rheumatol. 2019 Nov;38(11):3081-3092. doi: 10.1007/s10067-019-04649-4. Epub 2019 Jul 29.
- Derived from this study: PubMed 31130229Alemao E, Iannaccone CK, Weinblatt ME, Shadick NA. Association of Changes in Anticitrullinated Protein Antibody Levels With Resource Use and Disease Activity Measures in Rheumatoid Arthritis Patients a US Observational Cohort. Clin Ther. 2019 Jun;41(6):1057-1065.e3. doi: 10.1016/j.clinthera.2019.04.029. Epub 2019 May 23.
- Derived from this study: PubMed 29368271Ahmad HA, Alemao E, Guo Z, Iannaccone CK, Frits ML, Weinblatt M, Shadick NA. Association of Low Bone Mineral Density with Anti-Citrullinated Protein Antibody Positivity and Disease Activity in Established Rheumatoid Arthritis: Findings from a US Observational Cohort. Adv Ther. 2018 Feb;35(2):232-242. doi: 10.1007/s12325-017-0657-x. Epub 2018 Jan 25.
- Derived from this study: PubMed 29241640Alemao E, Guo Z, Frits ML, Iannaccone CK, Shadick NA, Weinblatt ME. Association of anti-cyclic citrullinated protein antibodies, erosions, and rheumatoid factor with disease activity and work productivity: A patient registry study. Semin Arthritis Rheum. 2018 Apr;47(5):630-638. doi: 10.1016/j.semarthrit.2017.10.009. Epub 2017 Oct 13.
- Derived from this study: PubMed 26238974Alemao E, Joo S, Kawabata H, Al MJ, Allison PD, Rutten-van Molken MP, Frits ML, Iannaccone CK, Shadick NA, Weinblatt ME. Effects of Achieving Target Measures in Rheumatoid Arthritis on Functional Status, Quality of Life, and Resource Utilization: Analysis of Clinical Practice Data. Arthritis Care Res (Hoboken). 2016 Mar;68(3):308-17. doi: 10.1002/acr.22678.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy A Shadick, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine and validate biomarkers that predict drug response and toxicity in RA. (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01793103, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.