Rheumatoid Arthritis Clinical Trial
— TETRADOfficial title:
Treatment Efficacy and Toxicity in Rheumatoid Arthritis Database and Repository
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado in Denver | Aurora | Colorado |
United States | Johns Hopkins University | Baltimore | Maryland |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Duke University | Durham | North Carolina |
United States | North Shore Medical Center (LIJ Health System) | Lake Success | New York |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Stanford University | Palo Alto | California |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
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 |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The number of enrolled patients will be used as a measure of success. | 2 years | No |
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