NCT01070121

Brief Summary

To stimulate collaborative efforts of federal funding agencies, voluntary health agencies, professional organizations and industry partners to enable creation of a large, sustainable database and repository to better understand the molecular basis of treatment and rapidly accelerate translational research in RA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2010

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
completed

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 Start

First participant enrolled

February 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 17, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

October 14, 2015

Status Verified

October 1, 2015

Enrollment Period

2.5 years

First QC Date

February 16, 2010

Last Update Submit

October 12, 2015

Conditions

Keywords

Rheumatoid ArthritisRAAutoimmune DiseaseMuscular Skeletal Disease

Outcome Measures

Primary Outcomes (1)

  • The number of enrolled patients will be used as a measure of success.

    2 years

Study Arms (1)

RA patients/participants

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Speciality/referral clinic, Community

You may qualify if:

  • Age 19 years or older;
  • Diagnosis of RA based on the cumulative presence of at least 4 of 7 ACR Criteria;
  • Willing and able to provide informed consent; and
  • One of the following:
  • Starting MTX OR
  • Previous or current use of Methotrexate and starting (or switching to) any of the following medications (with or without MTX)
  • Etanercept
  • Infliximab
  • Adalimumab
  • Rituximab
  • Abatacept
  • Golimumab
  • Certolizumab
  • Tocilizumab
  • There is no minimum disease activity (number of swollen joints, DAS28, CRP or ESR, etc.) necessary for enrollment. Treatment decisions are entirely at the discretion of the treating rheumatologist.
  • +2 more criteria

You may not qualify if:

  • Concomitant diagnosis of RA and systemic lupus erythematosus, juvenile arthritis, psoriatic arthritis, hepatitis C infection, current pregnancy or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

University of Colorado in Denver

Aurora, Colorado, 80045, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68105, United States

Location

North Shore Medical Center (LIJ Health System)

Lake Success, New York, 11042, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Related Publications (1)

  • Ormseth MJ, Yancey PG, Solus JF, Bridges SL Jr, Curtis JR, Linton MF, Fazio S, Davies SS, Roberts LJ 2nd, Vickers KC, Kon V, Michael Stein C; TETRAD Investigators. Effect of Drug Therapy on Net Cholesterol Efflux Capacity of High-Density Lipoprotein-Enriched Serum in Rheumatoid Arthritis. Arthritis Rheumatol. 2016 Sep;68(9):2099-105. doi: 10.1002/art.39675.

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, red blood cells, white blood cells, plasma, serum, DNA, RNA

MeSH Terms

Conditions

Arthritis, RheumatoidAutoimmune Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

  • S. Louis Bridges, Jr., MD, PhD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Division of Clinical Immunology and Rheumatology

Study Record Dates

First Submitted

February 16, 2010

First Posted

February 17, 2010

Study Start

February 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

October 14, 2015

Record last verified: 2015-10

Locations