Treatment Efficacy and Toxicity in Rheumatoid Arthritis Database and Repository (TETRAD)

This study has been completed.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Duke University
Johns Hopkins University
North Shore Medical Center
Stanford University
University of California, San Francisco
University of Colorado, Denver
University of Nebraska
University of Pittsburgh
Information provided by (Responsible Party):
S. Louis Bridges, MD, PhD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01070121
First received: February 16, 2010
Last updated: April 28, 2013
Last verified: April 2013
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment Efficacy and Toxicity in Rheumatoid Arthritis Database and Repository

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • The number of enrolled patients will be used as a measure of success. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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


Enrollment: 200
Study Start Date: February 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
RA patients/participants

Detailed Description:

Rheumatoid arthritis (RA) is the most common inflammatory arthritis, affecting ~1% of the US population. Severity of RA varies from mild synovitis to joint destruction with associated disability and increased mortality. Methotrexate (MTX) is the major drug used to treat RA and the anchor drug for clinical trials of investigational new drugs (INDs) in RA. Eight biologic agents are currently FDA-approved for RA. No drug is effective in every patient, and there is great variability in toxicity and price.

The use of concomitant MTX and biologic agents has dramatically improved the outcomes of RA treatment in the US. This proposal is based on the premise the next major advance needed in the treatment of RA is not additional drugs, but rather a dramatic improvement in the efficiency and cost-effectiveness of the use of drugs for individual patients with RA. One of the hopes for modern medicine is the realization of "personalized" medicine, which allows accurate, quick prediction of which drug will be the most efficacious, least toxic, and least expensive for an individual patient.

One of the major obstacles to identifying clinically useful markers of treatment response in RA is the lack of cohorts with prospectively collected treatment response data coupled with biological samples. Because of the importance of this issue and the paucity of funding for such efforts, multiple efforts to establish single institution (using institutional funds) or multisite cohorts and repositories (typically dependent on private practitioners and pharmaceutical company support) are planned. To date, there has been no attempt to harmonize the efforts of the US academic RA research community to create a public resource.

Recognizing that building de novo cohorts within a short time frame is not feasible, our current proposal will fill a critical need: establishing an infrastructure of academic investigators to lay the foundation for future collaborative large-scale registries; and uniting the efforts of many organizations with the common goal of improving care of RA patients. This project will facilitate future research that will result in significant, publicly visible improvements in health care. Identifying predictors of treatment response in RA will lead to rapid, early institution of optimal drugs rather than a "hit or miss" sequential approach; reduce adverse events; improve patient compliance; and lead to substantial reduction in the cost of health care. By unifying the efforts of academic researchers, we can create unique resources, such as a bank of cryopreserved blood cells to allow sophisticated immunologic research to dissect molecular signals of successful treatment of RA.

In order to determine the feasibility of this infrastructure for prospectively collecting data and samples we will enroll a small number of participants (10/site/year for each of 2 years, for a total of 200 participants).

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Speciality/referral clinic, Community

Criteria

Inclusion Criteria:

  1. Age 19 years or older;
  2. Diagnosis of RA based on the cumulative presence of at least 4 of 7 ACR Criteria;
  3. 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.

There are no combinations of drugs to be excluded, except those that do not include at least one of the seven drugs noted above.

Use of corticosteroids (oral, parenteral, intra-articular) is allowed, but must be recorded.

Exclusion Criteria:

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

  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: NCT01070121

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Stanford University
Palo Alto, California, United States, 94304
United States, Colorado
University of Colorado in Denver
Aurora, Colorado, United States, 80045
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68105
United States, New York
North Shore Medical Center (LIJ Health System)
Lake Success, New York, United States, 11042
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Alabama at Birmingham
Brigham and Women's Hospital
Duke University
Johns Hopkins University
North Shore Medical Center
Stanford University
University of California, San Francisco
University of Colorado, Denver
University of Nebraska
University of Pittsburgh
Investigators
Principal Investigator: S. Louis Bridges, Jr., MD, PhD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: S. Louis Bridges, MD, PhD, Director, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01070121     History of Changes
Other Study ID Numbers: F091007003
Study First Received: February 16, 2010
Last Updated: April 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Rheumatoid Arthritis
RA
Autoimmune Disease
Muscular Skeletal Disease

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

ClinicalTrials.gov processed this record on October 23, 2014