NCT01793103

Brief Summary

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

  1. 1.Determine and validate biomarkers that predict drug response and toxicity in RA.
  2. 2.Determine and validate biomarkers that predict disease activity and prognosis in RA.
  3. 3.Evaluate the natural history of treated RA in terms of its clinical, functional and economic outcomes.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,598

participants targeted

Target at P75+ for all trials

Timeline
22mo left

Started Mar 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Mar 2003Mar 2028

Study Start

First participant enrolled

March 1, 2003

Completed
10 years until next milestone

First Submitted

Initial submission to the registry

February 14, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2013

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

25 years

First QC Date

February 14, 2013

Last Update Submit

September 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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.

    15 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults 18 years or older with Rheumatoid Arthritis

You may qualify if:

  • 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.

You may not qualify if:

  • less than 18 years of age
  • do not have a diagnosis of RA
  • have a history of SLE or Psoriasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (7)

  • 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.

  • Zhuo 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.

  • Shadick 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.

  • Alemao 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.

  • Ahmad 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.

  • Alemao 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.

  • Alemao 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.

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, DNA

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Nancy A Shadick, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 14, 2013

First Posted

February 15, 2013

Study Start

March 1, 2003

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

September 26, 2025

Record last verified: 2025-09

Locations